Job Summary: 

• Plan, direct, or coordinat activities related to clinical and healthcare-related business operations to ensure compliance with regulations and units’ adherence to standard operating procedures.
• Provide guidance and assistance to the Chief Operating Officer for clinical/healthcare-related contract implementation.
• Supervise office and field-based teams of direct and indirect reports to include work allocation, training, reporting of all activity, and problem resolution.
• Evaluate overall team performance and make recommendations for team personnel actions.
• Consistently provide direct reports and/or indirect reports with support, coaching and encouragement necessary to achieve business goals.
• Use judgment and discretion to resolve less routine questions and problems and refer more complex issues to higher levels.
• Assure that staff have necessary professional, safety, and compliance training.
• Develop, implement, and enforce standard operating procedures for assigned units.
• Oversee daily allocation of resources to achieve SLAs.
• Create, edit, analyze, and present weekly, monthly, or quarterly deliverables.
• Maintain knowledge of all applicable industry standards, best practices, and regulatory impacts to assigned units of oversight.
• Ensure the pre-read, agenda, and meeting attendance and document meeting output and actions.

Skills on Resume: 

• Regulatory Compliance Management (Hard Skills)
• Contract Implementation Support (Hard Skills)
• Team Supervision and Leadership (Soft Skills)
• Performance Management (Soft Skills)
• Resource Allocation and SLA Management (Hard Skills)
• Operational Procedure Development (Hard Skills)
• Data Analysis and Reporting (Hard Skills)
• Meeting Management and Documentation (Hard Skills)

Job Summary: 

• Serves as the point-of-contact for CEP Medical to ensure operational delivery of assigned EG studies to time, budget and quality expectations as defined in the study protocol, ICH-GCP guidelines, GSK Corporate, SOPS and POLs.
• Works in close collaboration with SAPs to ensure the correct study information is in the GSK primary systems. 
• Maintains accurate, up-to-date information for planned, ongoing, and completed studies within CEP using GSK tracking systems. 
• Ensures that data and outputs are accurate and complete to ensure good decision-making.
• Provides oversight to SAPs/ SDLs to ensure that critical study timelines related to study activities are accurately forecasted and achieved and that recruitment targets, patient recruitment cycle times, data and audit quality are met for all CEP studies. 
• Provides troubleshooting and problem resolution support for local/regional study teams to ensure productive, efficient study delivery.
• Identifies and resolves or escalates issues and risks that may impact study delivery. 
• Takes a leadership role in identifying the root cause of issues, and implementing/influencing corrective and preventative actions locally or at a broader study level.
• Has accountability to estimate, track and deliver against the budget for the studies.
• Advises on contract development with CRO/Vendors and may participate in budget/contract negotiations with study vendors in collaboration with Global Procurement teams.
• Provides inputs/ advice to study teams in preparation of Informed Consent Form, Study Protocol, and Questionnaires ensuring all regulatory requirements are adhered to.
• Assists the Study team with audits/inspections for all EG studies.
• Leads/ manages the logistics and planning for meetings concerning EG e.g. IEP review meetings

Skills on Resume: 

• Project Management and Operational Oversight (Hard Skills)
• Expertise in GSK Systems and Tracking (Hard Skills)
• Data Accuracy and Decision Support (Hard Skills)
• Leadership and Team Collaboration (Soft Skills)
• Issue Identification and Risk Management (Soft Skills)
• Budget Management and Contract Negotiation (Hard Skills)
• Regulatory and Compliance Knowledge (Hard Skills)
• Audit and Inspection Support (Hard Skills)

Job Summary: 

• Ensuring we constantly improve quality in an evidence-based manner
• Ensuring uniformity across the Group
• Ensure there is a system in place to guarantee shared learning across all Homes
• Auditing all clinical aspects of each Home in a structured manner and developing an action plan
• Driving policies and updating and implementing new policies
• Ensure various budgets and agreed rostered hours are adhered to
• Provide a key role in managerial succession management
• Oversee complaints. Give guidance and direction to the DONs
• Liaising with stakeholders, HIQA, HSE, Discharge Planners, Disability Service Providers, Acute Hospitals, PHNs, NTPFs, etc.
• Chair the monthly DON meetings and attend scheduled meetings as set out by the CEO
• Keep up to date with changes in clinical governance, risk management, and infection control and drive best clinical practice through research/conferences/seminars etc.
• Play a key role in the growth strategy of the business

Skills on Resume: 

• Quality Improvement (Hard Skills)
• Standardization and Uniformity (Hard Skills)
• System Implementation for Shared Learning (Hard Skills)
• Auditing and Action Planning (Hard Skills)
• Policy Development and Implementation (Hard Skills)
• Budget Management (Hard Skills)
• Stakeholder Liaison (Soft Skills)
• Clinical Governance and Best Practices (Hard Skills)

Job Summary: 

• Support and execute the day-to-day operational aspects of clinical studies from the protocol concept through the clinical study report by project goals and objectives
• In compliance with applicable GCP/ICH guidelines, regulations, SOPs, and other global regulatory requirements
• Develop and manage comprehensive timelines and metrics
• Assist in the evaluation, selection, and management of external vendors, including organizing and/or hosting study-specific meetings, measuring key performance indicators, and vendor management governance
• Participate and have input in the development of clinical study synopsis and protocol in conjunction with the clinical development plan
• Assist in the planning of quality assurance activities and coordinate the resolution of audit findings
• Manage and oversee clinical vendors and their project deliverables
• Participate in the selection, training, and evaluation of study personnel (contract and internal) to ensure operational efficiency
• Serve as subject matter expert (SME) in one or more areas such as the development of SOPs, systems, tools, best in class standards for operational execution
• Takes a leadership role in standardizing processes within and across countries, identifying and sharing best practices in support of continuous improvement. 
• Represents local/regional clinical operations on global and cross-functional initiatives. 
• Serve in a subject matter expert (SME) capacity locally/globally & serve as an expert in ICH GCP and GSK written standards.

Skills on Resume: 

• Clinical Study Management (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Project Planning and Timeline Management (Hard Skills)
• Vendor Management (Hard Skills)
• Protocol Development (Hard Skills)
• Quality Assurance and Audit Resolution (Hard Skills)
• Training and Personnel Management (Soft Skills)
• Process Standardization and Improvement (Soft Skills)

Job Summary: 

• Leading implementation of clinical services with partner healthcare organizations
• Acting as a liaison between providers and partner healthcare organizations, and serving as the primary point person on each service-line
• Providing clinical operations based on consultative services and support
• Managing conflict and solving workflow challenges for the services you are responsible for
• Scheduling and facilitating introductory meetings, orientations, training, and clinical start dates
• Overseeing the completion of the necessary paperwork for medical licensing and credentialing
• Overseeing technology training and providing support for video conferencing software and EMRs
• Communicating with IT professionals at the partner organizations to coordinate training and testing of telepsychiatry hardware and software
• Arrange/coordinate scientific meetings, seminars and conferences and provide appropriate background materials.
• Prepares or reviews study-specific materials (e.g. guidelines, training manuals)
• Provides presentations and study-specific training
• Provides oversight for the setup, maintenance, and close-out of the Trial Master File and ensures it is complete and audit-ready

Skills on Resume: 

• Clinical Operations Management (Hard Skills)
• Liaison and Stakeholder Engagement (Soft Skills)
• Conflict Resolution and Workflow Optimization (Soft Skills)
• Training and Onboarding (Hard Skills)
• Medical Licensing and Credentialing (Hard Skills)
• Technology Training and Support (Hard Skills)
• IT Coordination for Telepsychiatry (Hard Skills)
• Meeting and Documentation Management (Hard Skills)

Job Summary: 

• Oversees and manages all clinical aspects of studies, ensuring that assigned studies adhere to approved protocols
• Manages and provides accountability for day-to-day operations of projects, as defined by the contract and according to applicable laws, rules, and regulations
• Serves as primary sponsor contact for operational project-specific issues and study deliverables
• Participates in the selection and management of external vendors, including developing vendor specifications and reviewing vendor reports, budgets, and invoices
• Responsible for oversight of vendor performance and vendor management strategies
• Perform periodic vendor visits to ensure compliance and maintenance of quality standards
• Manages recruitment efforts and activities to meet study enrollment goals and timelines, and provides status to upper management
• Provides input and coordinates the delivery of clinical trial supplies in collaboration with the study team
• Responsible for clinical trial material (CTM) label review and approval and assisting with CTM forecasting
• Ensures a consistent, standardized approach to operational activities and project management
• Establishes and reports key performance metrics to monitor progress of studies
• Proactively identifies and resolves operational issues, escalates study-related issues appropriately and promptly

Skills on Resume: 

• Clinical Study Management (Hard Skills)
• Vendor Management (Hard Skills)
• Operational Oversight (Hard Skills)
• Recruitment and Enrollment (Hard Skills)
• Clinical Trial Supply Coordination (Hard Skills)
• Performance Metrics and Reporting (Hard Skills)
• Problem Solving and Issue Resolution (Soft Skills)
• Standardization and Process Improvement (Hard Skills)

Job Summary: 

• Provide technical experience needed to manage the administrative functions within the clinic.
• Plan, coordinate and manage various programs and work projects.
• Coordinate committees for improving clinical program policies and procedures.
• Coordinate revisions to current clinical program activities.
• Coordinate special clinical projects, and the the activities of various clinical committees by providing logistical and technical support.
• Coordinate recruitment efforts for clinical fellowship programs.
• Act as a liaison with staff and other government and non-government offices.
• Ensure compliance with required program, administrative and management deadlines.
• Collect, enter and update data into the tracking database. 
• Assists with budget tracking and protocol management.
• Perform various clinical literature searches and receive, review and prepare clinical/technical reports.
• Advocates continuous quality improvement by evaluating methods and recommending efficient or novel approaches
• Supervises a team of direct reports, and assists in hiring, training, management, and evaluation

Skills on Resume: 

• Administrative Management (Hard Skills)
• Program Coordination (Hard Skills)
• Policy and Procedure Development (Hard Skills)
• Project Management (Hard Skills)
• Recruitment and Liaison Skills (Soft Skills)
• Compliance and Data Management (Hard Skills)
• Budget and Protocol Management (Hard Skills)
• Team Supervision and Quality Improvement (Soft Skills)

Job Summary: 

• Provide leadership and daily operational support to account teams to ensure outstanding service delivery
• Formulate strategic and operational objectives
• Work closely with GM to manage P&L with a focus on retention and growth of assigned accounts
• Develop, assess, and implement operational policies and procedures to ensure outstanding delivery of service.
• Support company QA standards and fortify a culture of continual quality improvement
• Establish and maintain excellent lines of communication with staff, internal teams, and client contacts.
• Proactively monitor team activity including daily check-ins with team leads and activity participation in Teams chats.
• Manage financial health of assigned book of business via P&L
• Hire, supervise, and evaluate the performance of all employees
• Work with internal leadership to meet contractual obligations
• Find ways to increase the quality of customer service
• Strike out agreements and ensure projects are running on time.
• Build relationships with KOL at sites, and work closely with vendors.

Skills on Resume: 

• Leadership and Team Management (Soft Skills)
• Strategic Planning and Operational Oversight (Hard Skills)
• P&L Management (Hard Skills)
• Quality Assurance and Improvement (Hard Skills)
• Effective Communication (Soft Skills)
• Team Activity Monitoring (Hard Skills)
• Contract and Project Management (Hard Skills)
• Relationship Building (Soft Skills)

Job Summary: 

• Ensures timely and quality responses to client inquiries regarding order status, test specifics, collection kit orders, and resolution of open tickets.
• Manages customer feedback and complaints resolution. 
• Functions as the customer contact on quality and delivery issues outside the routine scope of the Client Service Specialist
• Develops key performance metrics and robust reporting for measuring results, success, and impact, defining what success looks like for client services and clinical operations
• Drive efforts to refine clinical operations, investigate client-critical issues, scale best practices, identify challenges, and implement solutions
• Influences strategic decisions within the organization by making process recommendations, and implementing process improvement. 
• Extracts and analyzes the operational data to support any recommendations
• Leads projects that enhance the scalability of customer services and clinical operations solutions
• Establishes workflows and documentation for new client/product implementation, and asses the feasibility of customized workflows
• Partners with Lab Operations and Logistic Managers to ensure that patients/sample flow and volumes match current capacity and inventory levels, and to implement a system to maximize revenue and required service levels
• Leads and coaches Client Services team to drive a high-performance culture that accommodates rapid and dynamic growth and results in operational excellence and high employee engagement
• Collaborates with the teams across the organization including Customer Success, Logistic, Laboratory, and Engineering to meet client's expectations and to comply with regulatory requirements
• Work to maintain high-quality clinical studies that meet ICH, Good Clinical Practice standards, and local regulations.

Skills on Resume: 

• Client Relationship Management (Soft Skills)
• Performance Metrics Development (Hard Skills)
• Operational Excellence (Hard Skills)
• Strategic Process Improvement (Hard Skills)
• Data Analysis and Reporting (Hard Skills)
• Project Leadership (Hard Skills)
• Cross-Functional Collaboration (Soft Skills)
• Team Leadership and Development (Soft Skills)

Job Summary: 

• Implementing training sessions and education events across all sites according to the training schedule
• Updating and managing upcoming training dates on the booking software
• Working closely with the courses team and the clinic staff to make sure that the training courses run smoothly and have an adequate number of students and clinical models scheduled for each session.
• Remotely managing training stock supply, room management & room hire for all out-of-London training sites.
• Providing operational support to the trainers who run the sessions setting up equipment, software support, capturing and updating student information, monitoring session timing, ordering catering for the students
• Informing the course team of any student lateness or now show
• Helping to identify trends in student satisfaction and dissatisfaction
• Supporting students in the clinic environment and being the main contact between the courses team (office-based) and the clinic team
• Building and continuously updating knowledge on the training courses and contributing to continuous improvement
• Maintaining an exceptional customer experience at every touchpoint of the client’s and student experiences in the clinic and over the phone
• Managing educational events outside of usual training activities e.g. live webinars, and in-house training.
• Liaises directly with investigative sites and ECs/IRBs to facilitate the submission, initiation, and conduct of clinical projects, including contracts and budgets.

Skills on Resume: 

• Training Coordination and Management (Hard Skills)
• Operational Support (Hard Skills)
• Customer Service Excellence (Soft Skills)
• Communication Skills (Soft Skills)
• Data Management and Reporting (Hard Skills)
• Knowledge of Training Content (Hard Skills)
• Event Management (Hard Skills)
• Regulatory and Compliance Liaison (Hard Skills)

Job Summary: 

• Manage development and tracking of Clinical Research Process Metrics to facilitate continuous improvement.
• Verify that changes related to process improvements have been established through objective evidence review of metrics, documents, or other clinical research-related data.
• Manages Clinical Monitoring of employee performance and career development
• Performs site observation visits for applicable staff and develops performance improvement plans
• Develops training material and trains staff to applicable standards
• Responsible for hiring and onboarding permanent and contract CRAs
• Provide input into the strategic plan and long-range plan for the Clinical Affairs organization,
• Responsible for budgeting across all programs.
• Oversee vendor management and oversight (deliverables: enrolment, data coming out, hands-on management of CRO).
• Provides input into the clinical development program strategy and timelines including periodic reporting of status updates and budgets to upper management and project leads.
• Takes part in vendor identification and selection.
• Provide oversight for vendors, including Clinical Research Organization and core laboratories.
• Prepare regulatory documents and provide local adaptation of global documents to meet local regulations.

Skills on Resume: 

• Process Metrics Management (Hard Skills)
• Objective Evidence Review (Hard Skills)
• Performance Management (Soft Skills)
• Training and Development (Soft Skills)
• Recruitment and Onboarding (Soft Skills)
• Strategic Planning and Budgeting (Hard Skills)
• Vendor Management (Hard Skills)
• Regulatory Documentation and Compliance (Hard Skills)

Job Summary: 

• Supervise clinical research associates (CRA) and other employees in the completion of tasks and projects
• Train and mentor new employees, and serve as a resource for newly hired CRAs.
• Maintain a basic understanding of the principles of the assay and/or instrument.
• Implement and maintain the effectiveness of the quality system.
• Manage clinical operations activities in support of clinical study timelines and by applicable regulations, GCP, and divisional policies and procedures.
• Establish, track, and report Clinical Research Metrics to Senior Management.
• Participate in cross-divisional Clinical Research Collaborations
• Provide recommendations for strategic direction to align with the organization's long-range plan.
• Performs site observation visits for applicable staff and develops performance improvement plans
• Participates in SOP development/review and process improvement initiatives
• Assist with budgeting and contracting and provide project management for clinical trials
• Supports clinical research team with the review and monitoring of clinical study data

Skills on Resume: 

• Leadership and Supervision (Soft Skills)
• Training and Mentoring (Soft Skills)
• Technical Understanding (Hard Skills)
• Quality System Management (Hard Skills)
• Clinical Operations Management (Hard Skills)
• Metrics Tracking and Reporting (Hard Skills)
• Cross-Divisional Collaboration (Soft Skills)
• Strategic Planning and Project Management (Hard Skills)

Job Summary: 

• Support the organizational strategic objectives for all mental health services
• Support the Mental Health Programme Manager and provide leadership in clinical operations
• Manage clinical service delivery in schools and other settings, ensuring a high-quality service is provided
• Work with the Training & Development Manager to manage quality assurance processes.
• Oversee the management, retention and growth of mental health services contracts in a range of settings and organizations
• Recruit, deploy, oversee and quality assure a team of self-employed therapists and counsellors
• Develop and oversee the implementation of impact monitoring, assessment and outcome measurement processes to ensure services are needs-led, and evidence-effectiveness
• Identify, design and implement direct mental health services using evidence-based approaches involving consultation with stakeholders
• Adapt existing clinical services to new audiences such as youth organizations, housing, early years, and businesses.
• Support schools and settings with their mental health needs by providing advice, whole school wellbeing consultations and signposting to relevant services
• Work with the Training & Development Manager to actively keep up to date with new research, approaches and models to maintain high standards across all services
• Manage the development of non-clinical programs to raise awareness of mental health using a whole-setting approach, including the development of resilience programs, campaigns, events, PSHE curriculum resources, etc

Skills on Resume: 

• Strategic Leadership (Soft Skills)
• Quality Assurance Management (Hard Skills)
• Contract Management (Hard Skills)
• Impact Monitoring and Outcome Measurement (Hard Skills)
• Stakeholder Consultation and Service Design (Soft Skills)
• Adaptation and Innovation (Soft Skills)
• Training and Development (Hard Skills)
• Program Development and Management (Hard Skills)

Job Summary: 

• Lead, inspire and influence a team of 8-15 employees
• Responsible for ensuring robust performance management, development and succession management plans are in place for each employee
• Actively connect with people and champion employee engagement
• Build a network across the organization to remove barriers, resolve issues and champion operational excellence
• Participate in appropriate change management and Clinical Demand & Operations metrics to manage the business
• Lead by example in maintaining GMP/GCP compliance by following procedures applicable to clinical trial execution
• Appropriately escalate from issue identification through resolution within CTSP&E
• Actively work in partnership with CTSP&E roles to maintain effective relationships and ensure efficient and compliant processes
• Foster an environment of integrated teamwork and partnership via shared learning and accountability
• Able to use multiple technologies efficiently to participate in meetings and communicate within CTSP&E and across organizations
• Continuously identify and bring forth process improvement initiatives including standardization and/or re-engineering of processes and controls

Skills on Resume: 

• Leadership and Team Management (Soft Skills)
• Performance and Succession Management (Hard Skills)
• Employee Engagement (Soft Skills)
• Cross-Functional Networking (Soft Skills)
• Change Management and Metrics (Hard Skills)
• Compliance and Quality Assurance (Hard Skills)
• Issue Resolution and Escalation (Hard Skills)
• Process Improvement (Hard Skills)

Job Summary: 

• Foster a commitment within the operating room suites towards excellence, caring, cooperation, and collaboration to meet the needs of patients presenting for surgery or procedures. 
• Assist in the development, interpretation and implementation of policies and procedures. 
• Ensure periodic evaluation of operating room staff, including assisting with disciplinary action
• Develop and execute the scheduling and staffing plans for operating room personnel. 
• Make budgetary, scheduling and staffing decisions with direct input and oversight from the Director of Surgical Services.
• Review ancillary staff, make RN assignments and support and direct the clinical operation 
• Coordinate orientation precepts orients in conjunction with the education department.
• Evaluate patient acuity level, staff skill and experience level/mix and consider that when developing the schedule and staffing plans. 
• Collaborate with all hospital departments to ensure a strong, supportive organizational structure, functions and outcomes for both patients and staff members.
• Act as a liaison and fosters collaboration between staff, family, physicians, anesthesia and other patient care team members. 
• Possess the ability to understand, interpret and execute collective bargaining unit agreements. 
• Negotiate with patients and families to promote patient satisfaction when problems are identified.

Skills on Resume: 

• Leadership and Team Management (Soft Skills)
• Policy Development and Implementation (Hard Skills)
• Staff Evaluation and Disciplinary Action (Soft Skills)
• Budgeting and Scheduling (Hard Skills)
• Orientation and Training Coordination (Soft Skills)
• Patient and Staff Collaboration (Soft Skills)
• Collective Bargaining Agreement Knowledge (Hard Skills)
• Patient Satisfaction and Problem Resolution (Soft Skills)

Job Summary: 

• Provide some clinical sessions and an agreement depending on hours and qualifications.
• Proven ability to work on high-level value-add ad hoc projects while continuing to achieve routine goals
• Analyse and translate data into key strategic inputs and insights to drive decision-making
• Lead organizational changes
• Develop business plans to deliver clinical services that achieve a consistent standard of quality
• Contribute to area business planning with a focus on practice improvement and clinical interventions and support
• Apply knowledge of contemporary evidence-based practice models, including therapeutic models of care, delivering clinical supervision and reflective practice.
• Assess issues about preoperative and postoperative services
• Work together with all members of the surgical services areas to accomplish defined goals.
• Remain visible to staff and physicians throughout the day to be available
• Identify issues and roadblocks in surgical services areas needing improvements.
• Maintain a positive outlook and instill the same in staff.

Skills on Resume: 

• Project Management and Strategic Planning (Hard Skills)
• Data Analysis and Insight Generation (Hard Skills)
• Change Management (Hard Skills)
• Clinical Supervision and Evidence-Based Practice (Hard Skills)
• Surgical Services Coordination (Hard Skills)
• Visibility and Communication (Soft Skills)
• Problem-solving and Improvement Identification (Hard Skills)
• Leadership and Motivation (Soft Skills)

Job Summary: 

• Initiate appropriate action and address the issue using the chain of command, and escalate issues to the appropriate leadership personnel.
• Collaborate with staff to ensure appropriate follow-up and reporting of events that involve quality, safety and regulatory issues. 
• Coordinate and encourage staff development and clinical learning experiences for staff. 
• Monitor and validate staff competencies and education needs/ requirements.
• Promote an environment in which the patient care team can work cooperatively toward objectives. 
• Facilitate communication, critical thinking and problem-solving skills.
• Encourage staff to identify needs and areas where improvement in work processes or patient outcomes could be made. 
• Ensure adequacy of human and material resources, including equipment and deploy resources in a fiscally responsible manner with direct oversight from the Director. 
• Ensure that standards of patient care are appropriately implemented through concurrent oversight of the clinical area with support from the Director. 
• Ensure appropriate documentation of care delivered through chart review.
• Work independently in project teams to accomplish goals and objectives in the given time frame.
• Act as a role model for staff related to best practices.

Skills on Resume: 

• Leadership and Escalation Management (Soft Skills)
• Collaboration and Communication (Soft Skills)
• Staff Development and Education (Soft Skills)
• Critical Thinking and Problem-Solving (Soft Skills)
• Resource Management (Hard Skills)
• Standards Implementation and Oversight (Hard Skills)
• Documentation and Quality Assurance (Hard Skills)
• Independent Project Management (Hard Skills)

Job Summary: 

• Alert and aware at all times to ensure safety, accuracy and efficiency.
• Manage the overall Clinical Laboratory Operations and communicate with the Chief Operating Officer (COO) daily.
• Provide oversight for administration, production, quality assurance, quality control, and proficiency testing functions to meet all regulatory and accreditation standards.
• Provide direction by collaborating and communicating with lab supervisors and staff.
• Create a cohesive environment and promote teamwork and cross-training between the labs.
• Provide guidance and consultation to collection sites, customer service, and clients
• Direct adequate laboratory coverage through the development of staffing plans.
• Develop and direct implementation and updates of overall operational policies, procedures and services.
• Ensure safety standards and proper work habits are enforced.
• Act as working management that requires a physical presence in the laboratories.
• Manage multiple projects concurrently and set priorities in a fast-changing, results-oriented environment.
• Ensure timely review, release, and printing of client reports.

Skills on Resume: 

• Safety and Efficiency Management (Hard Skills)
• Operational Oversight (Hard Skills)
• Leadership and Communication (Soft Skills)
• Team Building and Cross-Training (Soft Skills)
• Consultation and Guidance (Soft Skills)
• Staffing and Coverage Planning (Hard Skills)
• Policy and Procedure Development (Hard Skills)
• Project Management and Prioritization (Hard Skills)

Job Summary: 

• Evaluate the quality of administration so performance standards are maintained for reporting test results, documenting validity, reliability, accuracy, precision, and performance characteristics of each test and each test system.
• Ensure remedial action is taken promptly when tests do not perform to specification.
• Conduct myself in an appropriate, professional manner and communicate timely with management and clients.
• Ensure self and staff receive education and training workshops, such as internal in-service programs, external seminars, meetings and continuing education courses required for CAP and other appropriate regulatory compliance.
• Directs compliance with regulatory standards and changes in test procedures.
• Coordinate company objectives with CLIA standards and establish lab priorities.
• Represent company for regulatory agencies such as CLIA, and CAP, including responsibility for regulatory inspections.
• Co-chair monthly CAP Laboratory meetings with the Laboratory Medical Director.
• Work directly with the COO and provide any support that is necessary for the areas such as, but not limited to, inventory control, purchasing, distribution, receiving, mobile phlebotomy, satellite Laboratories, potential service centers, sales, marketing, and R&D.
• Collaborate and sync with all teams and stakeholders to ensure timely completion of non-pivotal and pivotal studies
• Advise clinical team to streamline processes and maintain SOPs
• Represent the organization at internal and external events, membership groups, and strategic meetings to develop partnerships and share learning

Skills on Resume: 

• Quality Assurance and Compliance Management (Hard Skills)
• Remedial Action Implementation (Hard Skills)
• Professional Communication and Conduct (Soft Skills)
• Training and Development (Soft Skills)
• Regulatory Compliance and Coordination (Hard Skills)
• Leadership and Collaboration (Soft Skills)
• Process Improvement and SOP Maintenance (Hard Skills)
• Strategic Representation and Partnership Development (Soft Skills)

Job Summary: 

• Design and organize paper and EDC veterinary clinical studies to meet scientific goals and regulatory requirements (non-GCP and GCP)
• Produce required study documents and execute non-traditional study designs
• Identify and anticipate challenges in non-traditional clinical study designs and mitigate challenges
• Provide both on-site and remote training on study protocols, leadership, and general support to all internal and external study personnel
• Identify, select, and manage relationships with investigators, laboratories, and/or CROs
• Apply and obtain necessary study permits and licenses
• Plan and coordinate monitoring and data management activities for all clinical studies
• Prepare preliminary and final study reports and assist in the preparation of scientific publications
• Contributes to the development, implementation, and maintenance of standardized workflow and processes, SOPs, and systems
• Supports audits and inspection
• Support innovation and process optimization to speed drug development
• Responsible for oversight of study budgets, vendor contracts, and payments

Skills on Resume: 

• Clinical Study Design and Documentation (Hard Skills)
• Risk Management and Problem Solving (Hard Skills)
• Training and Support (Soft Skills)
• Relationship Management (Soft Skills)
• Regulatory Compliance and Permits (Hard Skills)
• Monitoring and Data Management (Hard Skills)
• Reporting and Publication (Hard Skills)
• Process Improvement and Budget Oversight (Hard Skills)