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Key Responsibilities and Required Skills for Clinical Operations Manager

💰 $95,000 - $160,000

Clinical OperationsHealthcareClinical Research

🎯 Role Definition

The Clinical Operations Manager is responsible for planning, executing and delivering clinical trials on time, on budget and in compliance with regulatory and quality requirements. This role leads cross-functional study teams, manages site and vendor relationships, develops and implements operational strategies (study start-up, monitoring, risk-based monitoring, patient retention), and continuously improves processes and metrics to accelerate study timelines and ensure patient safety. The ideal candidate combines hands-on clinical trial experience with strong project leadership, CRO/vendor oversight, financial stewardship, and a relentless focus on GCP, quality and patient-centric operations.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Clinical Research Coordinator (CRC)
  • Clinical Research Associate (CRA)
  • Study Start-Up Specialist or Clinical Trial Assistant (CTA)

Advancement To:

  • Senior Clinical Operations Manager
  • Director of Clinical Operations
  • Head of Clinical Development / VP, Clinical Operations

Lateral Moves:

  • Clinical Project Manager
  • Vendor/CRO Oversight Lead
  • Quality Assurance Manager (Clinical QA)

Core Responsibilities

Primary Functions

  • Lead end-to-end operational management for multiple clinical trials (Phase I–IV), including study start-up, site activation, monitoring, enrollment tracking, safety reporting, data flow, and close-out activities; ensure milestones and deliverables are met and escalate risks early to senior stakeholders.
  • Develop and maintain comprehensive study plans, timelines and resourcing models (including CRA coverage and vendor scope), drive cross-functional alignment across clinical, regulatory, safety, data management and biostatistics, and ensure on-time study execution.
  • Own site selection, feasibility and activation: manage feasibility assessments, negotiate site agreements and budgets, coordinate regulatory/IRB/EC submissions, oversee site initiation visits and ensure sites are enabled to meet enrollment targets.
  • Manage vendor and CRO partnerships: lead selection, contracting, KPI definition, operational oversight, performance reviews and corrective action plans to ensure vendor deliverables (enrollment, monitoring, data cleaning, eTMF) meet quality and timeline expectations.
  • Create, review and implement monitoring strategies (including risk-based monitoring and central monitoring plans), develop monitoring checklists and SOPs, and coach CRAs on monitoring quality, safety signal detection and protocol compliance.
  • Drive patient recruitment and retention strategies working with clinical operations, patient engagement and clinical sites; analyze enrollment trends, identify enrollment barriers, implement mitigation plans and revise projections to maintain study timelines.
  • Prepare and manage study budgets and financial forecasts: develop study-level budgets, track actuals vs. forecast, implement cost control measures, and report financial status to finance and senior leadership.
  • Ensure regulatory and GCP compliance across all operational activities: oversee essential documents in eTMF, ensure accuracy of regulatory submissions, manage audit and inspection readiness, and implement CAPAs when non-conformities are identified.
  • Lead safety and pharmacovigilance operational coordination: ensure timely adverse event reporting workflows, collaborate with safety teams on expedited reporting, and support safety signal assessments and action plans.
  • Draft, review and approve operational documents including monitoring plans, site training materials, study startup checklists, SOPs, working instructions and investigator communications to ensure consistency and quality.
  • Facilitate cross-functional study team meetings, steering committees and investigator meetings; prepare operational metrics, escalation summaries and executive-ready status updates to drive decision-making.
  • Implement quality management and continuous improvement initiatives: define operational KPIs (e.g., site activation time, enrollment velocity, query rates), lead root-cause analysis, and drive process standardization and automation to improve trial efficiency.
  • Oversee vendor deliverables related to eTMF, CTMS and EDC integration; validate that documentation and metadata meet inspection standards and support timely lock and submission-readiness.
  • Manage contract and budget negotiations with sites and vendors; ensure clear SOWs, milestones, acceptance criteria and reimbursement/payment controls are in place and executed.
  • Coordinate study close-out activities, including site closeout visits, archival of study documents, reconciliation of outstanding queries, and preparation of closeout reports to close studies within contractual and regulatory timelines.
  • Provide leadership, mentorship and performance management to direct reports (CRAs, study managers), including recruitment, training plans, career development and performance reviews to build a high-performing operations team.
  • Lead risk assessment activities and operational risk registers: identify study-level risks, develop mitigation and contingency plans, and ensure risks are visible and managed across stakeholders.
  • Drive protocol and amendment operational feasibility assessments and implement change-control processes to minimize disruption to timelines and quality during amendments.
  • Support regulatory interactions and health authority inspections by organizing operational responses, preparing documentation packages, and coordinating site-level remediation as required.
  • Oversee vendor oversight activities such as audit/training records review and performance analytics; ensure vendors adhere to company policies, SOPs and applicable regulatory requirements.
  • Partner with clinical data management and biostatistics to align on data collection plans, source data verification approach, query management SLA and timelines to support high-quality, inspection-ready datasets.
  • Lead commercial and medical affairs collaborations during study execution to ensure operational readiness for investigator interactions, medical monitoring and product handling.

Secondary Functions

  • Support ad-hoc operational and clinical data requests, including generating enrollment dashboards, monitoring trend reports and root cause analyses to inform program decisions.
  • Contribute to the organization's clinical data strategy and data governance for CTMS, eTMF and EDC systems, ensuring operational workflows produce clean, auditable clinical data.
  • Collaborate with business intelligence and data engineering teams to translate clinical operations requirements into tooling, dashboards and automated workflows that reduce manual effort and improve oversight.
  • Participate in sprint planning and agile ceremonies with cross-functional product and data teams when building or improving clinical operations platforms and integrations.
  • Represent clinical operations in process improvement and system selection projects, providing operational requirements, acceptance criteria and implementation support.
  • Engage with HR and L&D to define role competency frameworks, operations training curricula and onboarding plans for clinical operations hires.

Required Skills & Competencies

Hard Skills (Technical)

  • Clinical trial operations & study management (Phases I–IV) — proven record managing multi-site, multi-national studies.
  • Good Clinical Practice (GCP) and ICH guideline application in trial conduct and documentation.
  • Vendor and CRO management, including selecting, contracting, KPI setting and performance management.
  • Clinical Trial Management Systems (CTMS) and eTMF proficiency (e.g., Veeva Vault, Medidata Rave, Signant, Oracle CTMS).
  • Electronic data capture (EDC) understanding and oversight of query management and source data verification processes.
  • Risk-based monitoring (RBM) design and oversight, central monitoring approaches and monitoring plan creation.
  • Budgeting, forecasting and financial management for clinical studies; working knowledge of site budget negotiations.
  • Regulatory submissions and interactions support (IRB/EC, IND/IDE/CTA filings) and inspection readiness.
  • Safety operations coordination and familiarity with pharmacovigilance workflows and expedited reporting timelines.
  • SOP creation and governance, quality systems management and audit/inspection response experience.
  • Contract negotiation and management (site and vendor agreements; SOWs).
  • Proficiency with MS Office, project management software (e.g., MS Project, Smartsheet, Jira) and data visualization tools (e.g., Tableau, Power BI).

Soft Skills

  • Strong leadership and team development skills with the ability to influence cross-functional stakeholders.
  • Excellent written and verbal communication; prepares executive summaries and presents operational metrics clearly.
  • Strategic thinker with strong problem-solving and decision-making abilities under timeline pressure.
  • High attention to detail and commitment to quality and regulatory compliance.
  • Effective stakeholder management, diplomacy and negotiation skills.
  • Time management and prioritization across competing study demands.
  • Change management and process improvement orientation.
  • Patient-centric mindset and empathy for site staff and study participants.
  • Resilience, adaptability and comfort operating in fast-paced, ambiguous environments.
  • Data-driven mindset with ability to translate metrics into operational decisions.

Education & Experience

Educational Background

Minimum Education:

  • Bachelor's degree in Life Sciences, Nursing, Pharmacy, Public Health, Biomedical Sciences or related field.

Preferred Education:

  • Master's degree (MSN, MPH, MSc Clinical Research), PharmD, or MBA preferred; clinical or regulatory advanced degrees advantageous.
  • Professional certifications a plus: ACRP, SOCRA, PMP or equivalent clinical operations certifications.

Relevant Fields of Study:

  • Nursing
  • Clinical Research / Clinical Sciences
  • Pharmacy
  • Life Sciences (Biology, Biochemistry)
  • Public Health / Health Sciences

Experience Requirements

Typical Experience Range: 5–10+ years of progressive clinical operations experience with at least 3–5 years leading studies or managing CRAs/CROs.

Preferred:

  • 7+ years of direct clinical trial operations experience across multiple therapeutic areas and phases with proven track record of delivering complex, multinational studies.
  • Prior experience working with CROs, vendor oversight and global regulatory environments (US, EU, ROW).
  • Demonstrated experience with inspection readiness, successful regulatory audits and implementing continuous improvement initiatives.
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