CLINICAL OPERATIONS MANAGER JOB DESCRIPTION

A Clinical Operations Manager is the person a hospital or ambulatory care organization trusts to keep staff, patients, and processes moving in the right direction at the same time. This role owns staffing adequacy, regulatory and accreditation compliance, and the day-to-day delivery of care across one or more clinical departments or service lines. Bed allocation, incident resolution, and budget stewardship are all live concerns. Few management roles require holding both clinical standards and financial targets simultaneously, and fewer still do it while remaining accountable to state licensure bodies and Joint Commission requirements.

As the Clinical Operations Manager, you translate organizational priorities into reliable, compliant care delivery across assigned clinic sites or inpatient units, managing staff performance, facility readiness, and financial integrity in equal measure. The role reports to a Director or VP of Clinical Operations and works in close partnership with nursing leadership, physician groups, and multidisciplinary care teams spanning both clinical and administrative functions.

Career Impact: Overseeing compliance with Joint Commission standards and state licensure requirements builds the kind of regulatory fluency that distinguishes healthcare operations leaders from general administrators.

Business Impact: When bed allocation, staffing ratios, and care plan adherence are managed well, patient throughput improves and avoidable readmissions fall - outcomes that directly affect the organization's clinical reputation and operating margin.

Growth Opportunity: The Clinical Operations Manager seat is a recognized pipeline to Director of Clinical Operations and VP-level roles, particularly for those who develop budget ownership experience and advanced practice collaborative management.

• Lead staffing planning and resource allocation across assigned clinical units to maintain safe patient-to-staff ratios.
• Manage staff performance through goal setting, coaching, recognition, disciplinary action, and performance reviews.
• Oversee compliance with accreditation, regulatory, and institutional requirements across all assigned clinical areas.
• Coordinate patient admissions, discharges, and transfers using established flow protocols to reduce congestion and wait times.
• Administer departmental budgets, monitor financial targets, and identify opportunities for cost efficiencies within scope.
• Drive process improvements in access management, care quality, and service delivery based on monthly key indicator reports.
• Partner with physician groups, nursing leadership, and interdisciplinary teams to resolve care issues and align operational priorities.
• Develop and implement policies and procedures that promote clinical standards and frontline decision-making autonomy.

• Bachelor's degree in Nursing, Healthcare Administration, or a related field, or equivalent work experience.
• 3 or more years of clinical operations or healthcare management experience, with demonstrated responsibility for staff and budget.
• Knowledge of accreditation and regulatory requirements applicable to hospital or ambulatory care settings.
• Demonstrated ability to manage staffing, resolve patient care issues, and maintain financial integrity across clinic sites.
• Knowledge of managed care concepts, medical insurance coding including ICD-10 and CPT, and physician practice management.
• Strong organizational, delegation, and change management skills with a track record of meeting operational targets.
• Effective verbal and written communication skills with the ability to engage clinical staff, physicians, and senior leadership.

• Master's degree in Nursing, Healthcare Administration, or a related field, with exposure to programmatic quality improvement.
• Project Management certification or equivalent experience leading multi-workstream operational initiatives.
• Experience with Advanced Practice Clinician collaborative models or managed care population programs such as ACO or MCO structures.
• Familiarity with telehealth workflows and electronic medical record systems used in ambulatory or inpatient environments.

• Staff-to-patient ratio compliance rate, measured against regulatory and accreditation standards across assigned units.
• Percentage of patient complaints resolved within defined service recovery timeframes.
• Budget variance against departmental allocation, tracked monthly against financial targets.
• Regulatory audit readiness score, reflecting status of documentation, staff training records, and compliance logs.
• Bed utilization rate, measuring how effectively patient flow is managed to reduce over-census events.
• Typical tools: EMR platforms (commonly Epic or eClinicalWorks); reporting and care management software (commonly Excel-based dashboards or Looker).

• Base Salary Range: $85,000 to $115,000 annually, depending on setting and scope
• Bonus: Annual performance bonus of 5% to 10% of base salary
• Equity: Not typical at this level in hospital settings
• Health Benefits: Medical, dental, and vision coverage; employer contribution standard
• PTO: 18 to 25 days annually, plus standard holidays
• Common Perks: Tuition reimbursement, continuing education support, licensure renewal assistance

Figures are estimates based on general US market benchmarks and may be outdated. Adjust based on location, company size, and seniority level.

A background check, including verification of professional licensure and references, is required as a condition of employment in this role. All qualified applicants will be considered without regard to race, color, religion, sex, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, or local law. Candidates requiring a reasonable accommodation to participate in any part of the selection process should notify the hiring organization. Candidates must be authorized to work in the United States.

The Clinical Operations Manager owns daily operations of assigned clinical practice teams, overseeing staffing, compliance, and service issue resolution across medical, nursing, and ancillary staff. Reporting to senior leadership, this role delivers safe, accessible care by aligning interdisciplinary workflows with regulatory, accreditation, and financial targets.

Key Responsibilities

• Manages daily operations of assigned clinical practice teams to ensure safe, accessible care delivery.
• Coordinates workflow across medical, nursing, technical, ancillary, and office staff.
• Collaborates with leaders to align operations and implement interdisciplinary change initiatives.
• Maintains adequate staffing levels to meet patient needs.
• Ensures clinic teams effectively assess, plan, implement, and evaluate care.
• Resolves service and care issues, including patient complaints, within assigned area.
• Manages within allocated resources and makes operational adjustments to meet financial targets.
• Identifies capital needs and oversees background research for requests.
• Manages project activities, space planning, facility maintenance, supply procurement, and contract services.
• Implements changes related to access management, clinical quality, safety standards, and service excellence.
• Manages staff through selection, training, performance management, recognition, discipline, and termination.
• Assures a safe, productive, and supportive work environment for all staff.
• Ensures compliance with policy, regulatory, accreditation, and institutional requirements.
• Oversees frontline staff to maintain clinical standards in accordance with local, state, and federal requirements.

Required Qualifications

• Master's degree in behavioral health science.
• Licensed Marriage and Family Therapist, Mental Health Counselor License, or Licensed Independent Clinical Social Worker required at hire.
• Minimum 2 years of post-master's experience as a therapist.
• Minimum 1 year of management or supervisory experience in a clinical environment.
• Knowledge of regulatory requirements, managed care, and healthcare delivery systems.
• Demonstrated success in managing financial resources and meeting customer requirements.
• Demonstrated ability to recruit, mentor, develop, and engage staff and hold them accountable.
• Ability to manage multiple tasks simultaneously and prioritize effectively.
• Effective communication, collaboration, and change management skills.

Embedded within a veterinary hospital, the Veterinary Clinical Operations Manager shapes quality control processes, staff supervision, and daily departmental flow across clinical and support functions. Working closely with hospital and medical directors, inventory, facilities, and nursing development teams, this role builds a cohesive, compliant, and safe care environment.

Core Functions

• Ensures quality control within the hospital and oversees quality control processes.
• Maintains awareness of the day-to-day flow of services and hospital staff.
• Completes daily walkthroughs to ensure each department functions cohesively and efficiently.
• Assists hospital and medical directors in ensuring all staff work collaboratively.
• Ensures practice software operates at the highest level of efficiency.
• Assists clinical training managers with ongoing staff training and development, including evaluations and meetings.
• Assists department supervisors in facilitating resolutions and communicating determinations to appropriate team members.
• Supports the nursing development team with implementing hospital protocols and standards.
• Supports the inventory manager with controlled drug reporting and compliance.
• Assists the facilities manager with troubleshooting medical equipment.
• Participates in new medication, product, and equipment research and implementation.
• Provides effective supervision while enforcing hospital policies and procedures.
• Collaborates with the hospital operations manager on staffing needs.
• Facilitates meetings with clinical staff and hospital leadership team.
• Facilitates and maintains appropriate hospital certifications including Fear Free, RACE, and VECCS.
• Promotes a safe working environment and ensures adherence to OSHA guidelines and safety procedures.
• Upholds strict confidentiality of information related to operations, financial matters, and personnel management.

Qualifications & Experience

• College degree required.
• Minimum 5 years of experience in managing service-oriented operations.
• Veterinary or human medical leadership experience required.
• Proficient computer skills with the ability to navigate new software.
• Ability to plan, organize, and effectively present ideas and concepts.
• Ability to stay calm and efficient during a medical crisis.
• Proactive and problem-solving approach to challenges and tasks.
• Ability to assess information from multiple sources objectively and discern credibility.
• Ability to multi-task and manage high levels of stress in an environment of changing priorities.
• Excellent communication skills.

Reporting to senior management, the Clinical Operations Manager oversees all clinical and administrative aspects of clinical trial execution at a research site, including staff management, vendor contracts, and patient recruitment. Partnering with site teams and leadership on capacity planning and compliance, this role leads the delivery of study targets on time and to quality standards.

Primary Duties

• Manages staff through interviewing, selection, professional development, goal setting, performance management, coaching, mentoring, counselling, and separations.
• Approves decisions on salary administration, hiring, corrective action, and terminations.
• Reviews and approves time records, expense reports, leave requests, and overtime.
• Manages site activities to ensure delivery of targets received from senior management.
• Provides direct or indirect supervision of all clinical and administrative aspects of a clinical trial within the research site.
• Oversees cost efficiencies within the site and all vendor contracts for services.
• Continuously oversees staff schedules to ensure highest utilization of all resources.
• Evaluates and implements new operational strategies to enhance efficiencies and improve overall profitability.
• Communicates targets to site teams and continuously measures progress.
• Plans proactively for future studies and implements new therapeutic area initiatives.
• Collaborates with site and management on capacity planning and backup plans.
• Ensures patient recruitment activities are adequate for study requirements.
• Ensures compliance with the quality framework, regulatory legislation, and international standards.

Skills & Qualifications

• Knowledge of clinical trial processes, data management, clinical operations, quality management, and systems applications.
• Proficiency in EDC and eCRF systems.
• Advanced computer skills with proficiency in Microsoft Office and content management software.
• Demonstrated ability to analyze data, determine root cause of deficiencies, and provide recommendations.
• Skilled in leading process improvement activities.
• Ability to successfully mentor and train junior staff.
• Proficiency in reviewing and analyzing audit reports.
• Strong attention to detail and problem-solving abilities.
• Good organizational and time management skills.
• Excellent oral and written communication skills.
• Effective coaching and counselling skills.

Sitting at the intersection of clinical operations and medical device development, the Clinical Operations Manager oversees partner performance through meaningful metrics and implements continuous improvement objectives across quality, cost, and global clinical systems. Operating across cross-functional teams, geographies, and regulatory environments, this role leads delivery of interventional cardiology study commitments on time and within budget.

Duties

• Oversees and manages clinical functional work from partners through meaningful performance metrics.
• Provides direction and guidance to ensure business commitments such as timelines, quality, and budget are met.
• Implements continuous improvement objectives of quality, simplification, efficiency, and cost control.
• Supports global initiatives related to development of policies and procedures and implementation of global clinical systems.
• Interfaces and collaborates with clinical functions and departments across the clinical organization.

Requirements

• Bachelor's degree in Life Science, Nursing, Pharmacy, or Health Science.
• Minimum 8 years of related work experience.
• Minimum 4 years of experience in monitoring or study site management in the medical device industry.
• Minimum 3 years of experience in direct or indirect management of monitoring or trial operations staff.
• Knowledge of laws, regulations, and guidance governing conduct of pre- and post-market clinical studies on medical devices.
• Experience working with interventional cardiology products such as coronary therapy products and cardiac heart valves preferred.
• Experience working with and overseeing CRO work performance.
• Experience working in cross-functional teams across different locations and geographical regions.
• Proven experience with EDC, trial management, reporting, and documentation systems.
• Proven experience supporting internal audits and regulatory body audits.
• Experience contributing to or leading department initiatives focused on process improvement.
• Strong communication and presentation skills.
• Ability to work independently and solve complex problems.

A key member of the clinic leadership team, the Clinical Operations Manager I leads staff supervision, facility management, and financial compliance across clinic sites to ensure consistent care delivery and customer satisfaction. Collaborating across clinical and administrative functions, this role builds operational standards that support safety, regulatory compliance, and long-term business planning.

Functions

• Provides supervision to department staff and collaborates with clinician leadership on relevant clinical issues.
• Recruits and retains talented staff and ensures proper training, resource allocation, and performance evaluation.
• Implements and maintains clinical and business policies and procedures.
• Ensures customer satisfaction within clinic sites and resolves patient issues.
• Enforces strict adherence to policies related to financial integrity, including co-pays and charge entry.
• Manages facility planning and overall facility maintenance.
• Analyzes monthly key indicator reports relating to customer services, access, and financial goals.
• Educates staff and providers on monthly goals and areas for improvement.
• Contributes to the development of short- and long-term business planning.
• Ensures achievement of clinical and business compliance and licensure requirements for labs and staff.
• Manages all safety functions in clinics and ensures completion of safety training and proper orientation for new employees.

Experience & Qualifications

• Undergraduate degree or equivalent experience, or bachelor's degree in Healthcare, Nursing, Business Administration, or related field.
• 3 or more years of experience in healthcare, preferably in a clinic setting.
• 1 or more years of financial and cost accounting experience.
• Knowledge of financial cost analysis relating to personnel, inventory, production, and profitability.
• Knowledge of medical insurance including ICD-10 and CPT coding.
• Understanding of process flows regarding service levels, cash handling, and collections.
• Knowledge of customer service best practices, managed care concepts, and physician practice management.
• Proficiency in Microsoft Office Suite.

Operational excellence and regulatory readiness in mental health telehealth depend on the Clinical Operations Manager, who builds and tracks clinical KPIs, co-develops strategies with leadership, and translates initiatives into process improvements across operations, clinical, and product teams. Based within a growing start-up environment, this role advances evidence-based operational change by analyzing trends and gathering direct clinician input.

Accountabilities

• Establishes a deep understanding of clinical operations and processes within a growing start-up.
• Co-develops strategies to improve clinical operations.
• Builds, tracks, and improves clinical operational KPIs.
• Translates strategic initiatives into action to improve clinical operations.
• Conducts analyses and presents recommendations to the leadership team.
• Collaborates cross-functionally with operations, clinical, and product teams to ensure alignment and correct prioritization.
• Proactively gathers clinician input and proposes improvements to existing clinical processes.
• Reviews processes periodically to ensure documentation and process maps are current.
• Ensures regulatory compliance in all clinical processes and maintains audit readiness.
• Analyzes mental health clinical operations trends and proposes strategic initiatives.

Technical Qualifications

• 4 or more years of experience in operations at a start-up, management consulting, or investment banking environment.
• Experience analyzing operational data and designing and implementing interventions.
• Domain expertise in healthcare including knowledge of healthcare workflows, regulations, and software such as clinical notes, patient intake, HIPAA compliance, and EMRs.
• Digital health and telehealth experience a plus.
• Experience in a fast-paced environment with ability to work independently and with ambiguity.
• Strong analytical skills with ability to translate quantitative and qualitative findings into actionable insights.
• Strong interpersonal and collaboration skills with ability to work across a diverse team.
• Excellent presentation and communication skills.

As the Manager, Clinical Operations, this role leads budget administration, staff development, and evaluation of services to ensure quality, efficiency, and cost effectiveness within an inpatient cardiology setting. The clinical operations team relies on this work to maintain effective relationships with internal and external contacts and sustain ongoing professional growth.

Activities

• Plans, manages, implements, and evaluates operations and services to ensure quality, efficiency, and cost effectiveness.
• Prepares and administers budgets to ensure adequate personnel, facilities, and supplies.
• Selects, develops, motivates, and evaluates staff.
• Maintains effective working relationships with internal and external contacts.
• Pursues personal and professional growth and development.

Position Requirements

• Bachelor's degree in Nursing and master's degree in any field, or bachelor's degree in any field with a Master's degree in Nursing.
• RN licensure in the State of Illinois.
• 2 or more years of previous management experience in an inpatient setting, with cardiology experience preferred.
• 4 or more years of clinical RN experience with 2 years in telemetry or medical-surgical.
• Strong organization, planning, and delegation skills.

Clinical Operations Manager line-manages a team of disability assessors, delivering training and maintaining performance records to uphold assessment quality and regulatory standards. Success in the position means demonstrating full HCPC, NMC, or GMC membership and applying mentoring experience to continuously improve clinical support and new starter development.

Operational Focus

• Clinically and operationally line-manages a team of disability assessors.
• Delivers training effectively to team members.
• Modifies and improves clinical support based on self-reflection and new starter feedback.
• Maintains accurate records of disability assessors' performance and support plans.
• Assists the regional manager and other managers with additional duties as required.

Knowledge Skills & Abilities

• Full HCPC, NMC, or GMC membership required.
• Extensive knowledge of the PIP assessment process.
• Mentoring experience in a current or previous role.
• Strong IT skills.
• Excellent communication skills.
• Ability to work under pressure and prioritize effectively.

The Manager, Clinical Operations owns program management, data analytics, and operational support for the Advanced Practice Clinician Collaborative, designing and implementing projects and workstreams that advance APC-centric care delivery. Reporting to the VP of Clinical Quality, Practice, and Innovation and working closely with APC Directors and cross-functional teams, this role delivers professional development programs, quality improvement initiatives, and fiscal target compliance across the organization.

Key Deliverables

• Provides oversight of all projects, programs, and initiatives including project management, timelines, and progress updates.
• Provides programmatic and operational support for the Advanced Practice Clinician Collaborative.
• Develops strategic vision for expansion of APC-centric work through partnership, collaboration, and innovative programmatic changes.
• Designs and develops professional development opportunities and programs for APCs across the organization.
• Manages program processes and quality improvement of clinical practice initiatives.
• Collects, interprets, and tracks data for multiple initiatives.
• Evaluates and presents programmatic process and outcome measures.
• Facilitates meetings for multiple teams across the organization.
• Presents initiatives and programmatic progress to leadership.
• Develops and implements workflows, standards of practice documentation, and operational processes.
• Works cross-functionally across clinical and non-clinical teams to break down communication and operational barriers.
• Ensures operational and organizational compliance throughout all cross-functional settings.
• Resolves administrative problems and maintains open communication with staff to ensure a healthy work environment.
• Provides administrative support to APC Director and VP as needed.
• Supports preparation of the annual budget and maintains fiscal targets.

Professional Experience

• Master's degree in a healthcare-related field.
• Project Management Certification.
• 3 or more years of experience working in a healthcare or health insurance setting.
• Experience with quality improvement methodologies.
• Experience analyzing and leveraging data to support programmatic approaches and react to data trends.
• Experience working with a managed care or vulnerable patient population.
• Experience with MassHealth or Medicare programming and insurance products such as ACO, MCO, PACE, SCO, or OneCare.
• Intermediate to advanced proficiency in Excel.
• Familiarity with Medicare and MassHealth insurance products, programs, or operations.
• Proficiency in electronic medical record systems such as Epic or eCW preferred.
• Familiarity with telehealth technologies including video and chat platforms.
• Familiarity with IT platforms including EMR systems, care management software, Looker, Tableau, and project management software.
• Excellent organizational, problem-solving, and time management skills.
• Ability to function effectively within a multidisciplinary team.
• Ability to maintain confidential work relationships and handle confidential information with discretion.
• Demonstrated leadership skills.
• Strong interpersonal and customer relations skills.

Embedded within a hospital's after-hours operational structure, the Clinical Operations Manager delivers bed allocation management, patient flow coordination, and on-site leadership support across nursing units, emergency services, and interdisciplinary care teams. Working closely with on-call leaders, support services, and frontline staff, this role builds the communication infrastructure and policy frameworks that keep care safe, compliant, and efficient.

Areas of Ownership

• Provides leadership and support to staff, physicians, patients, and families during emergency or difficult situations.
• Executes day-to-day bed allocation activities after hours and on weekends.
• Liaises with on-site supervisors in support services and police and ambulance services as required.
• Escalates issues to the leader on-call or senior leader on-call where appropriate.
• Ensures follow-up and communication with managers and directors on any relevant issues.
• Ensures care is safe, evidence-based, competent, caring, and comprehensive in compliance with professional and regulatory standards.
• Ensures compliance with interdisciplinary patient care plans that include patient and family collaboration.
• Conducts regular rounds on all nursing units and continuously tracks alternate options for bed placements.
• Optimizes resource utilization, including staffing, and reorganizes staff to ensure safe and efficient workflow.
• Coordinates and supervises patient admissions, discharges, and transfers using established flow and access tools.
• Develops and maintains effective liaison with health care team members to facilitate discharge and admission planning.
• Assesses and makes recommendations where processes are not effective in facilitating flow.
• Tracks use of over-census beds using established tracking tools.
• Facilitates timely two-way communication among all stakeholders through meetings, memos, and committee work.
• Identifies opportunities for cost savings and revenue generation within areas of responsibility.
• Develops policy and procedures related to patient care to promote critical thinking and autonomy by frontline caregivers.

Education & Experience

• Undergraduate degree in a healthcare-related field required, with nursing preferred.
• Master's degree or evidence of substantial completion preferred.
• Current membership and good standing with a professional college required.
• Minimum 3 years of recent experience as a manager in a similar hospital environment.
• Excellent human resource management skills including recruitment and retention of staff.
• Excellent budgeting and financial management skills.
• Demonstrated commitment to continuing education.
• Superior verbal and written communication skills.
• Demonstrated change management skills.
• Strong conflict resolution skills.
• Patient and family engagement approach.
• Satisfactory employment and attendance record required.

Reporting to claims and medical vocational leadership, the Clinical Operations Manager leads a team of nurse disability consultants, coordinates high-quality clinical reviews, and manages external vendor services including peer reviews, IMEs, and FCEs. Partnering with claim operations peers and benefit specialists, this role shapes organizational capability, process improvements, and consistent clinical resource delivery across all assigned areas.

Role Responsibilities

• Analyzes reports and data to identify trends and resources that improve delivery of clinical review services.
• Builds organizational capability within assigned areas of responsibility.
• Collaborates with medical, vocational, and claims leadership to assess training needs and facilitate continuing education.
• Develops and implements clinical best practices in collaboration with management.
• Ensures top talent is hired and retained within assigned areas.
• Establishes and implements individual and team priorities, performance goals, and objectives.
• Identifies and recommends process improvements that reduce workloads or improve quality.
• Maintains current knowledge on emerging developments and trends and incorporates them into solutions.
• Manages a team and processes within assigned areas of responsibility.
• Manages and coordinates high-quality clinical reviews provided by nurse disability consultants.
• Manages and enhances organizational initiatives by supporting change management and departmental efforts.
• Manages and evaluates individual and team performance and takes action to meet or exceed performance standards.
• Ensures workloads are appropriately balanced among team members.
• Manages coordination of external clinical vendor services including peer reviews, IMEs, and FCEs.
• Partners with claim operations leadership and nurse disability consultants to ensure consistent clinical resource delivery.
• Performs quality assurance audits of nurse disability consultant written reviews and verbal consultations.
• Provides guidance to ensure individual work products meet or exceed defined management expectations.
• Provides training and development opportunities including stretch assignments and honest feedback.
• Serves as a resource to team members and stakeholders on complex assignments and projects.
• Finds common ground and gains collaboration among management, colleagues, and peers.

Background & Experience

• Ability to mentor others and provide constructive, performance-based feedback and coaching.
• Ability to perform under stress in cases of emergency or hazardous situations.
• Demonstrated ability to ensure workloads are appropriately balanced among team members.
• Demonstrated strong relationship management skills with internal clients including management, peers, and colleagues.
• Demonstrated success in hiring, retaining, coaching, and developing staff through a culture of real-time performance feedback.
• Demonstrated ability to identify and recommend process improvements.
• Excellent organizational skills with the ability to prioritize workload and multi-task while maintaining strict attention to detail.
• Strong interpersonal skills with a collaborative style.
• Ability to use sound judgment and discretion regarding confidential information.
• Effective planning, appropriate delegation, and persistent commitment to excellence.
• Ability to work with others in a team environment.

Sitting at the intersection of laboratory science and quality systems management, the Manager, Clinical Operations leads technical operations of the Clinical Laboratory, monitoring patient and quality control testing results, writing and reviewing SOPs, and ensuring CLIA and CAP standards are met. Operating under the Laboratory Director and Director of Clinical Operations, this role supervises licensed and unlicensed laboratory team members and drives assay validation, troubleshooting, and inspection readiness.

Job Functions

• Conducts and oversees daily quantitation and qualification assessment of molecular data generated during testing.
• Leads essential laboratory activities including reagent qualification, inventory management, procedure writing, inspection preparation, assay validation, and investigation.
• Works with laboratory supervisors on quality control and quality assurance procedures, technical troubleshooting, reagent manufacturing, and training programs.
• Reviews and documents routine preventive maintenance and independently troubleshoots highly complex problems affecting test performance.
• Identifies root cause and documents all corrective actions taken with test systems.
• Oversees training and competency of new and existing laboratory personnel.
• Manages stability studies, validation protocols, and process improvement projects.
• Participates in audits and inspections.
• Performs biennial review of standard operating procedures.
• Participates in introduction of assay improvements and new assay configurations.
• Supports the clinical operations team and manages daily laboratory operations including scheduling and independently troubleshooting complex technical and non-technical problems.
• Reports all concerns of test quality or safety to the laboratory director or safety officer.

Minimum Qualifications

• Bachelor's degree or equivalent in Biomedical Laboratory Science, Clinical Science, or related field.
• At least 8 years of high-complexity and high-volume laboratory experience preferred.
• At least 2 years of supervisory experience preferred.
• Working knowledge of local, state, and federal laboratory regulations.
• Working knowledge of FDA QSR and ISO 13485 requirements a plus.
• Experience in molecular biology techniques preferred.
• Ability to manage daily test processing needs with high emphasis on quality.
• Ability to analyze and problem-solve issues that impact test performance.
• Strong computer and automation skills.
• Ability to proactively communicate consistently, clearly, and honestly.
• Outstanding professionalism, leadership, and communication skills.
• Ability to integrate and apply feedback in a professional manner.
• Ability to work as part of a team.

A key member of the clinical operations leadership team, the Clinical Operations Manager leads recruitment, development, and oversight of direct reports while ensuring compliant, on-time delivery of clinical studies across an oncology therapeutic area portfolio. Collaborating across internal groups, business partners, and management at all levels, this role shapes inspection readiness, resource allocation, and process improvement within a pharmaceutical or CRO environment.

What You'll Do

• Provides performance management including coaching, mentoring, and routine feedback.
• Evaluates and projects resource needs on an ongoing basis.
• Ensures implementation of clinical studies through efficient allocation of staff and administrative associates.
• Ensures close working relationships between internal groups and business partners.
• Participates in and leads business-related task forces to improve processes.
• Ensures adequate, timely, and compliant monitoring and management of clinical studies.
• Ensures teams meet project deliverables according to timelines, within budget, and with quality.
• Ensures studies are in a constant state of inspection readiness.
• Communicates program changes, policy changes, and priority shifts to staff regularly.
• Monitors issues affecting staff workload and efficiency.
• Informs supervisor and fellow managers of potential problem situations and collaborates on problem resolution.
• Ensures staff fulfill roles and responsibilities appropriately and in a timely manner.
• Reviews and approves expense reports and ensures timely submission in compliance with policies.
• Participates in and conducts management and staff meetings.

Required Qualifications

• Minimum 5 years of experience in clinical research within the pharmaceutical, CRO, or biotech industry.
• Experience in the oncology therapeutic area required.
• Knowledge of CAR-T and cell and gene therapy preferred.
• Experience managing and executing clinical trials preferred.
• Experience with direct management of employees preferred.
• Demonstrated experience coaching and mentoring clinical operations team members preferred.
• Strong knowledge of Good Clinical Practices and FDA Code of Federal Regulations.
• Proficiency in Microsoft Office including Word, Excel, PowerPoint, and Outlook.
• Knowledge of GCO standard operating procedures.
• Excellent oral and written communication skills with strong presentation skills.
• Ability to collaborate with all levels of management in a matrix environment.
• Flexibility to work in a rapidly growing organization.

Consistent associate performance and regional compliance depend on the Clinical Operations Line Manager, who delivers line management, recruitment, training, and escalation support for CRO department staff across assigned countries and regions. Based within a growing clinical operations team and collaborating with project-level managers, this role builds associate capability against ICH and Good Clinical Practice standards.

Day-to-Day Responsibilities

• Manages line management of support and individual contributor-level associates within a specified department and country or region.
• Recruits, trains, develops, and allocates resources for associates in assigned country or region.
• Assists project-level managers with achieving project objectives by establishing performance standards and monitoring for consistency and compliance.
• Serves as a point of escalation for project teams related to individual associate performance.
• Supports development of departmental communications, training, and processes.
• Generates and conducts effective training programs.

Qualifications & Experience

• Bachelor's degree with 4 years of experience as a coordinator or specialist in a CRO-based department.
• Advanced knowledge of International Conference on Harmonisation and Good Clinical Practice standards.
• Strong leadership, mentoring, and motivational skills.
• Demonstrated ability to manage conflict and resolve problems effectively.
• Ability to provide constructive feedback on training performance and competency.
• Ability to monitor direct reports' overall capacity and performance.
• Excellent interpersonal, communication, and organizational skills.
• Proficient knowledge of Microsoft Office software.