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Key Responsibilities and Required Skills for Clinical Research Manager

💰 $85,000 - $150,000

Clinical ResearchHealthcareLife SciencesRegulatory AffairsClinical Operations

🎯 Role Definition

The Clinical Research Manager (CRM) leads operational delivery of clinical trials across phases I–IV, ensuring clinical, regulatory, safety, budgetary, and timelines objectives are met. The CRM supervises site selection and oversight, manages CROs and vendors, maintains compliance with ICH-GCP and applicable regulations (FDA, EMA), drives enrollment and retention strategies, and partners with cross-functional stakeholders (medical affairs, data management, biostatistics, regulatory affairs) to deliver high-quality clinical data for product development and commercialization.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Clinical Research Coordinator (CRC) with demonstrated site and monitoring experience.
  • Clinical Trial Associate (CTA) or Clinical Research Associate (CRA) transitioning to management.
  • Registered Nurse (RN) or Research Nurse with clinical trial exposure.

Advancement To:

  • Senior Clinical Research Manager / Senior Manager, Clinical Operations
  • Director of Clinical Operations or Head of Clinical Development
  • Global Clinical Program Lead or VP Clinical Development

Lateral Moves:

  • Clinical Project Manager
  • Clinical Quality Assurance Manager
  • Regulatory Affairs Manager
  • Vendor Management / Strategic Sourcing for clinical services

Core Responsibilities

Primary Functions

  1. Lead end-to-end operational planning and execution of multiple clinical trials (Phase I–IV), including development and maintenance of operational plans, timelines, and resourcing to ensure on-time, on-budget delivery of study objectives.
  2. Oversee protocol development and amendments from a feasibility and operational perspective; collaborate with medical monitors, biostatisticians, and regulatory affairs to translate protocol requirements into executable site and vendor activities.
  3. Manage site selection, feasibility, initiation, monitoring, and close-out activities; perform risk-based monitoring oversight and ensure site adherence to protocol, ICH-GCP, and local regulatory requirements.
  4. Develop and implement study-specific monitoring plans, visit schedules, and source data verification strategies; lead remote and on-site monitoring visits and ensure timely resolution of monitoring findings and CAPAs.
  5. Serve as primary sponsor-facing study lead for operational issues and cross-functional integration, convening study team meetings, owning study status reporting, and maintaining transparent communications with senior management and stakeholders.
  6. Direct and manage CRO and vendor relationships (clinical monitoring, central labs, imaging, supply chain), including vendor selection, contract and SOW review, performance metrics, escalation, and continuous improvement.
  7. Oversee clinical trial budgets and financial tracking, including budget development, forecasting, milestone payments, revenue recognition in collaboration with finance, and negotiation of site and vendor contracts to optimize cost-efficiency.
  8. Drive subject recruitment and retention strategies in partnership with site teams, patient advocacy groups, and digital outreach; develop contingency plans to mitigate enrollment risks and meet enrollment targets.
  9. Implement, maintain, and inspect study documentation (eTMF, essential documents) to guarantee completeness, audit readiness, and regulatory inspection compliance; coordinate eTMF reconciliation and quality checks.
  10. Ensure timely and compliant safety reporting, including identification, documentation, classification, expedited reporting of SAEs/AEs, and coordination with pharmacovigilance teams for CIOMS and regulatory submissions.
  11. Partner with data management and biostatistics to ensure data quality, query resolution, and alignment on data cut timelines; support interim analyses and readouts by delivering operational input and data integrity oversight.
  12. Lead development and enforcement of study SOPs and work instructions; ensure study teams and sites are trained on protocol, safety reporting, and GCP expectations; organize investigator meetings and training materials.
  13. Manage study start-up activities including regulatory filing preparation, IRB/EC submissions, informed consent review and approval, investigational product logistics, and site activation milestones.
  14. Oversee investigational product (IP) management and supply chain logistics: forecasting, packaging, labeling, storage, temperature excursions, accountability, and reconciliation at sites and central depots.
  15. Monitor and improve study operational performance using KPIs and metrics (enrollment, query rates, site performance, monitoring coverage); prepare dashboards and actionable insights for continuous process optimization.
  16. Facilitate cross-functional risk assessments and mitigation plans for clinical programs, maintaining a study risk register and leading escalations to senior leadership when critical issues arise.
  17. Ensure compliance with data privacy and security requirements (HIPAA, GDPR as applicable) in all study operations, including contracts with vendors processing PHI and patient-facing digital tools.
  18. Lead hiring, mentoring, and performance management of clinical operations staff (CRAs, study coordinators); build high-performing teams through coaching, development plans, and resource allocation.
  19. Coordinate and support regulatory inspections and audits by sponsors and regulatory authorities, including preparation of inspection packages, hosting, and post-inspection remediation plans.
  20. Drive continuous improvement initiatives for clinical operations processes (monitoring efficiency, site training, eTMF completeness), leveraging lessons learned to scale best practices across programs.
  21. Manage investigator and site relationship building, including investigator meetings, site visits, reimbursement processes, and ensuring high-quality documentation to foster long-term site engagement.
  22. Oversee quality control activities for essential documents, site files, and study reports; author and review clinical operations sections of regulatory submissions and investigator brochures as needed.
  23. Lead change control processes and ensure timely implementation and communication of protocol amendments, study updates, and regulatory obligations across sites and vendors.
  24. Prepare and present operational summaries and program updates to internal leadership, protocol steering committees, and external stakeholders, ensuring clarity on milestones, risks, and next steps.

Secondary Functions

  • Support ad-hoc regulatory or operational data requests and provide clinical operations input for ad hoc analyses and cross-functional decisions.
  • Contribute to organizational clinical operations strategy, SOP development, and process standardization to scale high-quality clinical research.
  • Collaborate with business units (medical, regulatory, data science, commercial) to translate clinical needs into operational requirements and efficient execution plans.
  • Participate in agile or project-management ceremonies to align cross-functional teams, sprint plans, and resourcing for study deliverables.
  • Act as backup for escalation management during off-hours for critical trial safety or compliance events.

Required Skills & Competencies

Hard Skills (Technical)

  • Deep knowledge of ICH-GCP, FDA, EMA, and local regulatory requirements and demonstrated experience applying these in study design and operations.
  • Proven experience with eTMF and CTMS platforms (e.g., Veeva Vault, CTMS systems) including document indexing, reconciliation, and audit-readiness processes.
  • Experience with EDC systems and data query management (e.g., Medidata RAVE, Oracle Inform, REDCap) and collaboration with data management teams.
  • Expertise in clinical monitoring practices, risk-based monitoring (RBM), monitoring plan development, and performing source data verification.
  • Strong understanding of safety reporting workflows, SAE handling, CIOMS and expedited reporting timelines, and interface with pharmacovigilance.
  • Budgeting and financial management skills for clinical studies including forecasting, invoicing, milestone tracking, and vendor payment controls.
  • Contract and vendor management expertise, including SOW negotiation, SLA/KPI development, and vendor performance oversight for CROs, labs, and imaging vendors.
  • Proficiency in project management tools and methodologies (MS Project, Smartsheet, Jira) and ability to manage complex cross-functional timelines.
  • Knowledge of investigational product (IP) logistics, temperature-controlled supply chains, accountability, and reconciliation processes.
  • Strong documentation skills including writing and reviewing SOPs, monitoring reports, study plans, and sections of regulatory submissions.

Soft Skills

  • Leadership and team management: ability to hire, coach, and retain clinical operations talent and build collaborative study teams.
  • Excellent verbal and written communication skills for interacting with investigators, regulators, vendors, and internal stakeholders.
  • Strong problem-solving and decision-making under pressure, with an emphasis on risk mitigation and root-cause analysis.
  • Stakeholder management and negotiation skills to align priorities across clinical, medical, regulatory, and commercial teams.
  • Attention to detail and quality focus to ensure protocol adherence, data integrity, and audit-ready documentation.
  • Time management and organizational skills to drive multiple studies simultaneously and meet tight regulatory deadlines.
  • Adaptability and resilience in fast-paced development environments and during regulatory or operational changes.
  • Influencing and presentation skills for steering committees, investigator meetings, and executive reporting.
  • Cultural sensitivity and patient-focus to support diverse investigator sites and patient populations.
  • Continuous improvement mindset with the ability to implement process change and measure impact with KPIs.

Education & Experience

Educational Background

Minimum Education:

  • Bachelor's degree in life sciences, nursing, pharmacy, public health, or related discipline.

Preferred Education:

  • Master's degree in Clinical Research, Public Health, Business Administration, or related field; or Registered Nurse (RN) with advanced clinical research experience.

Relevant Fields of Study:

  • Clinical Research
  • Nursing
  • Pharmacy
  • Biological Sciences
  • Public Health
  • Health Sciences

Experience Requirements

Typical Experience Range:

  • 5–10 years of progressive clinical research experience with at least 3–5 years in clinical operations or site monitoring; experience varies by therapeutic area and company scale.

Preferred:

  • 7+ years managing clinical trials with direct experience supervising CRAs and managing CRO/vendor partners; prior experience with complex multi-center or global trials, demonstrated regulatory inspection readiness, and budget/contract management.
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