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Key Responsibilities and Required Skills for Clinical Trials Supervisor

💰 $ - $

Clinical ResearchClinical OperationsHealthcare

🎯 Role Definition

The Clinical Trials Supervisor is a hands-on clinical operations leader responsible for planning, executing and overseeing multicenter interventional clinical studies to ensure patient safety, regulatory compliance, data integrity, on-time enrollment and high-quality deliverables. This role combines team leadership, site oversight, regulatory stewardship and cross-functional coordination with sponsors, CROs, sites, safety teams and vendors to deliver trials in accordance with ICH-GCP, FDA/EMA regulations and company SOPs.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Clinical Research Associate (CRA) — field monitor with progressive monitoring experience.
  • Clinical Trial Coordinator / Study Coordinator — site-facing coordination background.
  • Research Nurse / Clinical Nurse Specialist — direct patient care in clinical research settings.

Advancement To:

  • Clinical Trial Manager / Senior Clinical Operations Manager
  • Head of Clinical Operations / Director of Clinical Research
  • Clinical Program Director / Global Study Lead

Lateral Moves:

  • Project Manager (Clinical Programs)
  • Regulatory Affairs Specialist / Safety (Pharmacovigilance)
  • Vendor Management / CRO Oversight Lead

Core Responsibilities

Primary Functions

  • Lead day-to-day operational oversight of assigned clinical trials including study start-up, site activation, recruitment tracking, monitoring cadence, close-out activities and ensuring timelines and milestones are met according to the study plan and CTMS.
  • Supervise, mentor and provide performance management for CRAs, study coordinators and site support staff; develop training plans, conduct team meetings, and ensure consistent application of monitoring standards and SOPs across the study team.
  • Develop and manage monitoring strategies and study-specific monitoring plans (including risk-based monitoring approaches); assign monitoring schedules and ensure completion of source data verification (SDV), query resolution and documentation of monitoring findings.
  • Serve as primary point of contact for investigational sites, sponsors, CRO partners and study vendors; maintain strong working relationships to proactively resolve operational impediments and expedite issue resolution.
  • Ensure regulatory compliance for all study conduct activities by overseeing IRB/EC submissions and approvals, maintaining regulatory binders, managing amendments and ensuring adherence to ICH-GCP and local regulatory requirements.
  • Oversee safety surveillance processes including timely detection, documentation and escalation of adverse events (AEs), serious adverse events (SAEs), relatedness assessments and expedited safety reporting to sponsors and regulatory authorities per timelines and policy.
  • Manage investigational product (IP) logistics and accountability at sites including shipment coordination, temperature excursion monitoring, IP reconciliation, destruction/return procedures and maintenance of IP records.
  • Coordinate study budgets, monitor site payments and investigator agreements (IAAs), track financial deliverables and partner with finance to forecast resource needs and cost impacts for study milestones.
  • Drive enrollment optimization and retention strategies by analyzing enrollment metrics, leading corrective action plans for underperforming sites and implementing targeted site support and patient engagement tactics.
  • Oversee data quality and integrity by ensuring timely and accurate eCRF/EDC entry, query management, adjudication workflows and collaboration with data management to resolve discrepancies prior to lock.
  • Lead or support vendor selection, contracting and oversight activities for central labs, imaging vendors, IVRS/IWRS, data vendors and CRO partners; develop vendor oversight plans and conduct regular performance reviews.
  • Prepare, review and approve monitoring visit reports, site corrective and preventive action plans (CAPAs), deviation logs and study-level documentation to ensure audit-ready study files.
  • Coordinate and lead investigator meetings, site initiation visits (SIVs), interim site training and close-out visits to ensure protocol comprehension, compliance and standardized study execution.
  • Collaborate with Medical Affairs, Biostatistics and Data Management to support safety signal reviews, interim analyses, DSMB interactions and data freeze activities; ensure clinical input is documented and reflected in study reports.
  • Maintain study master file (TMF) oversight and ensure timely, complete and quality-controlled filing consistent with DIA TMF Reference Model and company standards for inspection readiness.
  • Conduct routine internal monitoring quality checks, internal audits and mock inspections; implement corrective actions and continuous quality improvement initiatives to address recurring trends.
  • Draft, review and update study-specific SOP supplements, monitoring guidance, work instructions and training materials to reflect evolving regulatory expectations and process optimizations.
  • Participate in regulatory inspections and audits as study SME: prepare inspection materials, support auditor requests, respond to findings and implement remediation plans to achieve regulatory closure.
  • Track and report study performance metrics and KPIs (enrollment rates, query rates, protocol deviations, monitoring coverage) to senior management and sponsor partners; translate metrics into actionable plans.
  • Oversee site risk assessments and implement mitigation strategies (e.g., targeted monitoring, additional training, temporary staffing) to control data quality and participant safety risks.
  • Ensure informed consent processes are followed at sites; review consent forms for version control, ascertain proper documentation and support remediation if consent-related issues are identified.
  • Manage cross-functional study teams and change control processes: facilitate protocol amendments implementation, communicate impacts to sites and vendors, and update study documentation.
  • Implement and maintain clinical technology systems relevant to study operations (CTMS, EDC, eTMF, eConsent, IVRS) and liaise with IT to troubleshoot access, data flow and compliance matters.
  • Oversee reconciliation of study supplies and other study-related inventories; ensure appropriate record keeping, storage conditions and compliance with import/export regulations where applicable.
  • Support development and review of clinical study reports, monitoring summaries and regulatory submissions by providing operational context, site-level data interpretation and documentation of study execution.
  • Champion patient-centric study conduct: work with sites to reduce patient burden, enhance retention, manage travel stipends, and ensure equitable access and adherence to protocol visit schedules.

Secondary Functions

  • Provide ad-hoc operational analyses and forecasting to support portfolio decision-making and prioritize study resources based on enrollment and risk metrics.
  • Support cross-study initiatives such as process improvement, standardization of monitoring tools, and development of training curricula for new clinical hires.
  • Participate in site feasibility assessments and contribute operational input to protocol and budget negotiations for new studies.
  • Collaborate with clinical quality assurance to support internal audits and follow-up on CAPA implementation.
  • Support business development and study start-up teams with operational feasibility insights and site identification when needed.

Required Skills & Competencies

Hard Skills (Technical)

  • In-depth knowledge of ICH-GCP, FDA and EMA regulations, local regulatory frameworks and applicable ethical standards for clinical research.
  • Proven clinical monitoring experience with strong competency in on-site and remote monitoring methodologies, including risk-based monitoring (RBM) approaches.
  • Proficiency with clinical systems: CTMS (e.g., Veeva, Medrio CTMS), EDC/eCRF platforms (Medidata Rave, Oracle Clinical, REDCap), eTMF systems and IVRS/IWRS.
  • Demonstrated experience with safety reporting and pharmacovigilance procedures including SAE reporting timelines, expedited reporting and safety database interactions.
  • Strong experience preparing and managing regulatory submissions to IRBs/ECs, coordinating amendments and maintaining regulatory documentation.
  • Budget management and financial acumen for clinical studies: experience managing site budgets, payments, investigator agreements and forecasting.
  • Experience with vendor selection, contract oversight and performance monitoring for CROs, central labs, imaging vendors and other third parties.
  • Practical knowledge of investigational product handling, accountability, temperature monitoring and chain of custody procedures.
  • Ability to interpret clinical protocols, statistical analysis plans, CRFs and study manuals to guide operational execution.
  • Experience preparing for and supporting regulatory inspections and audits including preparation of inspection-ready TMF and CAPA execution.
  • Familiarity with clinical metrics/KPIs, dashboards and data visualization tools to track enrollment, queries and other operational performance indicators.
  • Experience drafting SOPs, monitoring plans, training materials and CAPA documents with a quality-focused mindset.

Soft Skills

  • Strong leadership and people management skills with the ability to coach, motivate and develop cross-functional teams.
  • Excellent oral and written communication skills; able to explain complex clinical and regulatory concepts to diverse stakeholders.
  • Superior organizational skills and attention to detail; capable of managing multiple studies and priorities in a fast-paced environment.
  • Proactive problem solving and critical thinking with a bias for action to remove operational roadblocks and escalate appropriately.
  • Stakeholder management and negotiation skills to influence sponsors, CROs, vendors and investigative sites.
  • Resilience and adaptability to changing timelines, regulatory expectations and study requirements.
  • Collaborative team player with strong cross-functional influencing skills and the ability to work effectively with medical, data, regulatory and commercial partners.
  • Cultural sensitivity and patient-centered mindset to support diverse patient populations and global study operations.

Education & Experience

Educational Background

Minimum Education:

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

Preferred Education:

  • Master’s degree (MS, MPH, MRes) or advanced clinical degree (RN, PharmD) or certification in Clinical Research (e.g., ACRP, SOCRA).

Relevant Fields of Study:

  • Nursing
  • Pharmacy
  • Biology / Biomedical Sciences
  • Public Health / Epidemiology
  • Clinical Research / Health Sciences

Experience Requirements

Typical Experience Range: 5–10 years of progressive experience in clinical research with direct site monitoring experience.

Preferred: 7+ years in clinical operations including at least 2–3 years in a supervisory or lead role overseeing CRAs, site management and cross-functional clinical teams; experience with Phase II–III multicenter trials and global regulatory environments preferred.

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