CLINICAL OPERATIONS MANAGER SKILLS, EXPERIENCE, AND JOB REQUIREMENTS

Updated: Dec 10, 2024 - The Clinical Operations Manager has experience in clinical operations management, with a strong background in global clinical studies and effective mentoring capabilities. This role involves proficiency in program and protocol management, budget tracking, and collaboration with cross-functional teams, adhering to GCP practices and ICH guidelines. The manager also possesses extensive healthcare experience, including clinical research and advanced therapies, alongside line management and account management expertise.

Essential Hard and Soft Skills for a Standout Clinical Operations Manager Resume
  • Clinical Trial Management
  • Regulatory Compliance
  • Budget Management
  • Data Analysis
  • SOP Development
  • Quality Assurance
  • Vendor Management
  • Project Management
  • Risk Assessment
  • Resource Allocation
  • Leadership
  • Communication
  • Problem-Solving
  • Adaptability
  • Team Collaboration
  • Attention to Detail
  • Time Management
  • Critical Thinking
  • Decision-Making
  • Conflict Resolution

Summary of Clinical Operations Manager Knowledge and Qualifications on Resume

1. BS in Clinical Research Management with 7 years of experience

  • Have progressive experience in clinical research within the biotech, pharmaceutical sector, CRO industry, or relevant field
  • Documented training, knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials
  • Management experience of CROs and other Vendors 
  • Therapeutic or medical knowledge
  • Experience developing trial plans including project plans, site monitoring, pharmacy and lab manuals, risk mitigation strategies, trial budgets and site selection/feasibility
  • Exhibits a strong understanding of methodologies and approaches
  • Strong written and verbal communication skills
  • Strong communication skills to be able to foster close collaboration with internal/external stakeholders
  • Demonstrated ability, or potential, to excel in smaller entrepreneurial organizations.
  • Excels at developing strong patient/family relationships that foster engagement and the best outcomes

2. BS in Nursing with 5 years of experience

  • Active Registered Nurse (RN) or Nurse Practitioner (NP) license
  • Have progressive experience in the management of clinical operations
  • Have management/leadership experience within the healthcare or related field
  • Ability to teach, strong organizational skills, excellent communication, customer service, relationship development, results orientation, team building and decision-making.
  • Understanding of Value-Based Care and having change management experience
  • A sense of humor, an optimistic outlook, and an ability to bounce back quickly 
  • Ability and willingness for occasional work over weekends
  • Have related clinical experience, including three years in a leadership role.
  • Current registration with the relevant professional college or association
  • Ability to create structure, protocols, policies, and procedures within the company and for BetterHelp counselors

3. BS in Health Sciences with 3 years of experience

  • Full licensure (unencumbered) - Equivalent of LMFT, LMHC, LPCC, LCPC, LCSW, Clinical Psychologist by date of hire
  • Have an online counseling forum from a clinical perspective 
  • B obsessed with privacy, security, confidentiality, and compliance
  • Experience providing counseling online
  • Understand and respect different therapeutic approaches
  • Ability to exercise sound judgment around who is a good fit for online counseling, as opposed to clients who might require a different level of care
  • Excellent written and verbal communication skills
  • Analytical and metrics-driven, with a proven track record of making decisions based on data
  • Experience working for a startup or other fast-paced, fast-growing environment
  • Experience providing customer support over email, phone, or chat

4. BS in Pharmaceutical Sciences with 7 years of experience

  • Experience in management within an ambulatory clinical practice setting
  • Be comfortable using a variety of computer systems, including practice management and electronic health record systems such as Athena, Epic, etc.
  • Be adept at identifying and implementing process improvement opportunities
  • Be familiar with regulatory requirements about medical practices, including documentation and billing, quality reporting (HEDIS, QARR), and environmental requirements to ensure safety for members and staff
  • Have excellent communication skills, including the ability to effectively interact with all members of the care team, and with members of the public
  • Have managed staff in a clinical practice setting and work well with clinical teams including physicians and Advanced Practice Clinicians
  • Experience with deep, hands-on process improvement
  • Be compassionate, open-minded, and non-judgemental
  • Ability to think quickly and solve problems in the moment
  • Understanding of general finance and budgeting, including profit and loss and balance sheet

5. BS in Public Health with 6 years of experience

  • Current California State Registered Nurse License and CPR certification
  • Havw full-time clinical nursing experience in oncology, apheresis, blood bank, or dialysis
  • Clinical supervisory experience with multiple direct reports
  • Demonstrated leadership skills and people management skills
  • Strong computer skills with knowledge of Microsoft Word, Excel, and Google Apps required
  • Willingness to learn additional job-relevant software (donor database management system, electronic medical records).
  • Usually walking or standing to do work with some sitting, bending, and stooping
  • Some pushing and/or pulling of wheeled equipment, as well as some lifting
  • Work is performed in an environment that involves everyday risks and discomforts requiring safety precautions typical of outpatient medical clinics.
  • Tasks involve exposure to blood, body fluids, or tissues

6. BS in Biology with 2 years of experience

  • Experience in management, operations, and leadership
  • In-depth understanding of clinic workflows and EMR documentation.
  • Excellent communication and outstanding organizational skills
  • Ability to build consensus and relationships among managers, employees, and customers
  • Experience in the management of a scribe or transcription company
  • Experience with electronic health records
  • Experience as a practice administrator or similar role
  • Experience in developing and implementing operational procedures and policies
  • Experience with Athena, Epic, or Cerner
  • Experience with coding and in-house billing

7. BS in Biochemistry with 7 years of experience

  • Successful history of developing a good rapport and positive working relationships with clients and associates at all levels of an organization 
  • Attention to detail and strong verbal and written communication skills.
  • Must display a high level of personal initiative, good judgment, and time management
  • Ability to properly prioritize work and make independent decisions while working from home.
  • Extensive knowledge of clinical operations methodologies, patient recruitment, document management, clinical trial management systems (CTMS) and electronic data capture (EDC) systems, investigational product accountability, and budget management.
  • Ability to maintain the confidentiality of all client, patient, and proprietary information.
  • Ability to adapt and meet fluctuating business priorities in a dynamic, fast-paced environment.
  • Works by principles of Good Clinical Practice and applicable state, federal, and local regulatory authority regulations.
  • Strong skills in both verbal and written communication
  • French (along with English) language fluency

8. BS in Biomedical Sciences with 2 years of experience

  • Experience in clinical research and some experience in project management
  • Knowledge of the research area is a strong asset.
  • Knowledge of and experience in budget preparation
  • Ability to work independently and take initiative, set priorities, manage, and resolve problems in a fast-paced environment
  • Expertise in the following computer programs - MS Word, Excel, PowerPoint, Outlook, Adobe Acrobat, WordPress
  • Exceptional administration and organization skills
  • Attention to detail and good time management
  • Works very well under pressure
  • Problem-solving and hands-on attitude
  • Experience in setting up digital equipment (AV, Camera, lights, microphones, Laptops, iPads, etc)

9. BS in Healthcare Administration with 3 years of experience

  • Enjoys exploring opportunities and using their initiative
  • Articulate and confident communicator
  • Be able to work occasional weekends and evenings
  • Has an interest in start-ups and an understanding of the challenges of working in a rapidly evolving environment
  • Experience managing a team and being a team player with excellent social skills
  • Proven work experience in clinical operations management or a similar role
  • Excellent organizational skills and strong supervisory and leadership skills
  • Ability to prioritize, and manage tasks effectively
  • Ability to work independently and attention to detail
  • Outgoing, excellent interpersonal skills

10. BS in Medical Technology with 4 years of experience

  • Commitment to operational effectiveness
  • Excellent customer service and collaboration skills with strong customer focus and a demonstrated ability to work seamlessly with clients
  • Experience in pharmaceutics, biologics, biomedicine, or other life science-related fields
  • Experience of late-stage (phase II and III) clinical development experience with a proven record in the management of multi-center clinical trials
  • Excellent project management skills
  • Ability to train and supervise site staff and CRAs
  • Ability to work well within a project team
  • Excellent verbal and written communication skills
  • Good planning and organization skills
  • Experience building and leading highly effective teams
  • Sponsor Management experience

11. BS in Life Sciences with 5 years of experience

  • Experience in a Clinical Operations position with a biotech or pharma.
  • Experience working with clinical CROs and other vendors.
  • Passion to develop therapeutics to improve patients' lives.
  • Comfortable in a small biotech environment where responsibilities are open-ended and everyone must work collaboratively together.
  • Demonstrated ability to develop effective working relationships with clients and associates at all levels of an organization
  • Experience with the supervision and management of employees
  • Experience in contracting and managing vendors for clinical research
  • Experience developing study plans and budgets and working with clinical trial management systems
  • Experience managing staff/teams.
  • Must have built and managed a budget.

12. BS in Health Information Management with 6 years of experience

  • Experience in leadership - effective mentoring capabilities
  • Extensive clinical operations management experience (preferably for global clinical studies)
  • Ability to communicate and collaborate well with cross-functional team members
  • Supporting and implementing best practices and continuous improvement
  • Familiar with GCP practices and ICH guidelines
  • Demonstrates experience working in a clinical environment.
  • Demonstrates experience with program and protocol management, and budget tracking.
  • Healthcare experience ( i.e. clinic operations, clinical research, clinical coordinator, healthcare project management.)
  • Account management working experience 
  • Must have worked with cells/advanced therapies.
  • Line Management working experience
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