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Key Responsibilities and Required Skills for Clinical Trial Manager

💰 $95,000 - $150,000

Clinical ResearchClinical OperationsHealthcareLife SciencesRegulatory AffairsProject Management

🎯 Role Definition

The Clinical Trial Manager (CTM) leads and coordinates all operational aspects of clinical studies from start-up through close-out. The CTM is accountable for delivering high-quality, compliant, on-time clinical trials by managing cross-functional teams, vendors, investigational sites, and stakeholders. Key responsibilities include study planning and execution, site monitoring strategy and oversight, regulatory adherence (ICH-GCP, FDA, EMA), budget and timeline management, safety and quality assurance, and continuous process improvement. The CTM is the primary operational owner of one or multiple clinical studies and ensures all activities meet protocol, regulatory, and organizational standards.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Clinical Research Associate (CRA) — field or lead CRA
  • Study Coordinator / Clinical Research Coordinator (CRC)
  • Project Coordinator or Clinical Project Assistant

Advancement To:

  • Senior Clinical Trial Manager / Senior Clinical Project Manager
  • Clinical Program Manager / Head of Clinical Operations
  • Director of Clinical Operations or Global Clinical Operations Lead
  • Vice President, Clinical Development or Head of Clinical Programs

Lateral Moves:

  • Regulatory Affairs Manager
  • Pharmacovigilance / Safety Lead
  • Clinical Supplies Manager / Vendor Management Lead
  • Medical Affairs or Clinical Science Manager

Core Responsibilities

Primary Functions

  • Lead end-to-end operational management of complex clinical trials, including protocol implementation, study start-up, enrollment strategies, site activation, monitoring, and study close-out to achieve enrollment, timeline, quality, and budget targets.
  • Develop, maintain, and oversee comprehensive study plans, timelines, milestone trackers, and risk mitigation plans; proactively identify critical path items and escalate issues to cross-functional stakeholders.
  • Manage global and/or regional study teams (internal staff and external vendors such as CROs, central labs, IVRS/IWRS vendors) through clear role definitions, SOP adherence, performance monitoring, and regular cross-functional status reporting.
  • Create and maintain study budgets, financial forecasts and resource plans; negotiate vendor contracts and manage financial change control to ensure trials stay within approved financial constraints.
  • Design, implement and oversee site management and monitoring strategies (including central and risk-based monitoring approaches), assign monitoring resources, and ensure monitoring reports accurately reflect compliance and data quality.
  • Ensure regulatory compliance with ICH-GCP, local regulations and sponsor policies by overseeing submission packages, regulatory document collection, site regulatory binder reviews, and interactions with regulatory authorities and ethics committees.
  • Serve as the primary operational contact for investigative sites, providing guidance on protocol interpretation, informed consent procedures, safety reporting, and query resolution to maintain site engagement and data integrity.
  • Oversee safety reporting and pharmacovigilance interactions for the study, ensuring timely collection, assessment and submission of serious adverse events (SAEs), expedited safety reports, and safety data reconciliation with clinical operations and safety teams.
  • Manage trial documentation through robust eTMF practices and CTMS maintenance; ensure completeness, version control, metric reporting, and audit-readiness of essential trial documents.
  • Lead study start-up activities including feasibility assessments, site selection and qualification visits, site initiation visits (SIVs), regulatory submissions, and investigator contract and budget negotiations.
  • Coordinate data management, biostatistics and medical writing inputs for CRF design, data listings, interim analyses, statistical analysis plans, and clinical study reports to ensure alignment with study objectives and timelines.
  • Drive quality oversight and process compliance through regular QA checks, monitoring of key quality indicators (KPIs), root cause analysis of deviations, and development of CAPAs with cross-functional partners.
  • Manage change control processes for protocol amendments, ensuring timely implementation across sites, update of study documents, re-training of study teams and communication with regulatory authorities as needed.
  • Prepare and present study updates and risk/status briefings to senior leadership, steering committees, and cross-functional governance bodies, using clear metrics and actionable recommendations.
  • Coordinate vendor selection, oversight, and performance management (CROs, laboratories, imaging vendors, clinical supply partners), including SOW definition, vendor audits, KPI monitoring, issue resolution, and contractual compliance.
  • Oversee investigational product (IP) and clinical supply strategy including forecasting, labeling, distribution, accountability, and destruction according to protocol, chain-of-custody, and regulatory requirements.
  • Collaborate with patient recruitment and engagement teams to develop enrollment plans, site incentives, outreach strategies and retention initiatives to meet recruitment targets.
  • Facilitate investigator meetings, site trainings and internal cross-functional learning sessions to ensure alignment on protocol requirements, safety reporting, data capture and operational processes.
  • Prepare for and support regulatory inspections and sponsor audits by coordinating responses to audit findings, ensuring corrective actions are implemented, and maintaining an inspection-ready state.
  • Lead post-study close-out activities including final site close-out visits, essential document reconciliation, archiving of eTMF and site documentation, and final study financial reconciliations.
  • Implement continuous process improvement initiatives by analyzing operational metrics, identifying bottlenecks, proposing process redesigns, and deploying best practices across programs.
  • Mentor and develop junior CRAs and CTM team members through coaching, training, performance feedback, and professional development planning to build a high-performing operations team.

Secondary Functions

  • Support due diligence and feasibility assessments for new study protocols, contributing operational insights to study design and budget estimation.
  • Participate in cross-functional project teams (regulatory, safety, data management, biometrics) to align operational execution with scientific objectives.
  • Maintain repository of lessons learned and post-study evaluations to inform future trial design and operational planning.
  • Contribute to SOP and template development or updates to reflect industry best practices and regulatory changes.
  • Assist clinical operations leadership in resource forecasting and capacity planning across study portfolios.
  • Participate in site relationship-building activities and investigator engagement to support long-term partnerships.

Required Skills & Competencies

Hard Skills (Technical)

  • Deep knowledge of ICH-GCP guidelines, FDA and EMA regulations, and local regulatory requirements for clinical trials.
  • Proven experience with Clinical Trial Management Systems (CTMS) such as Veeva, Medidata Rave, or Oracle CTMS.
  • Proficiency with Electronic Data Capture (EDC) platforms (e.g., Medidata Rave, REDCap) and understanding of CRF design principles.
  • Experience managing eTMF systems and knowledge of document lifecycle, metadata, indexing, and regulatory filing requirements.
  • Demonstrated competency in risk-based monitoring (RBM) frameworks and centralized monitoring techniques.
  • Strong understanding of pharmacovigilance processes and SAE expedited reporting requirements.
  • Budgeting and financial management skills for clinical studies, including change control and vendor invoicing reconciliation.
  • Experience managing CRO/vendor relationships, writing SOWs, and monitoring vendor performance metrics and SLAs.
  • Familiarity with clinical supply chain management, IP accountability, labeling, and distribution logistics.
  • Ability to interpret statistical outputs, interim analyses, and to collaborate with biostatistics to support data-driven operational decisions.
  • Proficiency with MS Office Suite (Excel pivot tables, PowerPoint, Word) and project management tools (Jira, Trello, MS Project).
  • Knowledge of regulatory submission processes for IRB/EC and competent authority interactions.

Soft Skills

  • Strong leadership and people management skills, including coaching, delegation, and performance management.
  • Excellent written and verbal communication abilities to interact with investigators, cross-functional teams, and executive stakeholders.
  • Superior organizational skills and attention to detail, with the ability to manage multiple competing priorities concurrently.
  • Analytical and problem-solving mindset; able to translate operational metrics into actionable improvements.
  • Influencing and negotiation skills for vendor contracts, site budgets, and internal stakeholder alignment.
  • Resilience and adaptability to operate effectively in fast-paced, evolving clinical environments.
  • Stakeholder management and diplomacy, including cultural sensitivity for global studies.
  • Time management and prioritization skills to meet tight regulatory and study timelines.
  • Critical thinking and decision-making under uncertainty, balancing risk, quality and speed.
  • Collaboration and team orientation to work across diverse functional areas and external partners.

Education & Experience

Educational Background

Minimum Education:

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

Preferred Education:

  • Master's degree (e.g., MSc in Clinical Research, MPH) or advanced clinical degree (RN, PharmD, PhD) is preferred for complex or global programs.

Relevant Fields of Study:

  • Clinical Research
  • Nursing
  • Pharmacy
  • Biomedical Sciences
  • Public Health
  • Regulatory Affairs

Experience Requirements

Typical Experience Range:

  • 3–8 years in clinical research with at least 2–4 years in clinical trial operations or as a senior CRA; demonstrated experience managing full study lifecycle for Phase I–III trials.

Preferred:

  • 5+ years of progressive responsibility in clinical trial management, including experience with global trials, cross-functional leadership, vendor/CRO oversight, and regulatory inspections.
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