Key Responsibilities and Required Skills for Clinical Trials Director

🎯 Role Definition

The Clinical Trials Director is a senior clinical operations leader responsible for the end-to-end delivery of global clinical trials across phases II–IV (and often earlier or pivotal programs). This role provides strategic leadership and operational oversight for study design, study start-up, site management, vendor/CRO partnerships, regulatory interactions, safety/pharmacovigilance integration, budget and resource management, quality assurance, and cross-functional alignment with clinical development, regulatory, biostatistics, safety, and commercial teams. The Clinical Trials Director is accountable for timely, compliant, and cost-effective execution of clinical programs while mitigating risk and ensuring patient safety and data integrity.

📈 Career Progression

Typical Career Path

Entry Point From:

Senior Clinical Research Associate (Sr. CRA) or Lead CRA
Clinical Project Manager / Senior Project Manager
Medical Monitor or Clinical Operations Manager

Advancement To:

Senior Director, Clinical Operations
Vice President (VP) / Head of Clinical Development
Global Head of Clinical Operations / Chief Medical Officer (CMO)

Lateral Moves:

Director, Regulatory Affairs
Director, Clinical Quality Assurance (QA)
Director, Clinical Program Management / Portfolio Lead

Core Responsibilities

Primary Functions

Lead the development and execution of clinical operations strategy for assigned programs, ensuring alignment with overall clinical development plans, regulatory strategy (FDA/EMA/PMDA), and corporate objectives; prioritize studies and resources to meet development milestones.
Serve as the functional and operational leader for multiple concurrent clinical trials, providing oversight of timelines, milestones, enrollment targets, protocol adherence, and deliverables to senior management and cross-functional stakeholders.
Provide clinical trial protocol oversight including design input, feasibility assessments, site selection strategy, and operational planning to optimize recruitment, retention, and data quality.
Manage end-to-end study start-up activities (site identification, feasibility, site initiation visits, regulatory submissions and approvals, contracts and budgets) to accelerate site activation while ensuring compliance with local regulations.
Lead vendor and CRO selection, contracting, and oversight activities; establish performance metrics, SLAs and governance to ensure vendor accountability and high-quality deliverables.
Oversee clinical monitoring strategy and execution, including risk-based monitoring (RBM/RBQM), monitoring plans, central monitoring activities, and escalation pathways to resolve site and data issues quickly.
Provide oversight and direction for safety and pharmacovigilance integration within trials (timely SAE reporting, expedited reporting, signal detection collaboration with PV teams) and ensure investigator safety reporting obligations are met.
Own study budgets and financial management for clinical programs: develop cost estimates, track actuals vs. budget, manage financial forecasts, and implement cost-control strategies while maintaining study quality.
Lead cross-functional study teams (medical affairs, regulatory, biostatistics, data management, safety, legal, commercial) through effective program governance, steering committees and regular status reporting to ensure timely decision-making.
Ensure compliance with ICH-GCP, GCP regional requirements, clinical SOPs, and applicable regulations; lead corrective and preventive actions (CAPA) in response to audits, inspections, or quality issues.
Drive continuous improvement of clinical processes, operational playbooks, and best practices; implement lessons learned across programs to increase efficiency and reduce cycle times.
Oversee eTMF and clinical documentation management to ensure completeness, contemporaneous documentation and regulatory readiness for inspections.
Provide leadership in regulatory submission support (IND/CTA/MAA components) by ensuring the clinical data package meets regulatory requirements and supports filing timelines.
Partner with biostatistics and data management to define data collection strategies, CRF design, EDC selection, database lock timelines, and deliverables to support analysis-ready datasets.
Mentor, hire, and develop high-performing clinical operations teams; build team capability in project management, clinical monitoring and vendor oversight to scale clinical programs.
Implement and maintain trial risk management frameworks; identify, assess and mitigate operational risks across sites, vendors, and countries to protect patient safety and data integrity.
Champion patient-centric trial design and operational tactics (remote visits, decentralized trial components, patient recruitment strategies and retention programs) to enhance enrollment and participant experience.
Coordinate and lead internal and external study governance forums (steering committees, DSMBs, advisory boards) and prepare executive-level briefings and risk/mitigation plans.
Coordinate global regulatory interactions and inspection readiness activities; prepare responses to regulatory queries and manage remediation activities following inspections or audits.
Drive timelines and deliverables for clinical trial milestones including first patient in (FPI), last patient in (LPI), last patient out (LPO), database lock (DBL), and clinical study report (CSR) readiness.
Oversee data quality and integrity initiatives including query management, reconciliation activities, and collaboration with data science/biostatistics to ensure robust, audit-ready datasets.
Negotiate and manage study contracts, site budgets, confidentiality agreements and clinical trial agreements to protect company interests while accelerating study start-up.
Oversee the integration of real-world evidence (RWE) or external control arms where applicable, partnering with epidemiology and outcomes teams to align operational and analytical approaches.
Ensure timely and clear communication with investigators, site staff and key opinion leaders (KOLs) to strengthen site relationships and optimize site performance and retention.
Lead post-marketing or phase IV studies and registry trials ensuring pharmacovigilance, real-world data capture, and commercial alignment when required.

Secondary Functions

Support development and implementation of digital and decentralized trial components (telemedicine, ePRO, remote monitoring) and oversee vendor/technology integration to enhance trial efficiency.
Contribute to the organization's clinical operations strategy and roadmap, identifying capability gaps and recruitment needs to scale trial portfolios.
Collaborate with enrollment/feasibility teams and commercial stakeholders to translate market and patient insights into operational trial requirements and recruitment plans.
Participate in governance meetings, strategic portfolio reviews, and risk/issue management forums to advise on operational feasibility and resource allocation.
Support ad-hoc cross-functional analyses (site performance, enrollment forecasting, budget modeling) to inform senior leadership decisions and prioritization.
Facilitate training and onboarding of new clinical staff and investigators on protocol procedures, GCP requirements, and study-specific processes.
Drive clinical quality assurance initiatives including internal audits, vendor audits, and remediation plans to uphold regulatory compliance and inspection readiness.
Assist in preparation of study materials for investigator meetings, regulatory submissions and publication planning to ensure accurate operational representation.
Maintain up-to-date knowledge of industry trends, regulatory changes and trial innovation to inform process enhancements and strategic decisions.
Serve as a point of escalation for complex operational or regulatory issues, coordinating cross-functional resolution and decision-making.

Required Skills & Competencies

Hard Skills (Technical)

Deep knowledge of ICH-GCP guidelines, FDA, EMA and other regional regulatory requirements, with proven experience preparing for regulatory inspections and responding to regulatory queries.
Demonstrated experience in designing and executing clinical trial protocols across phases II–IV, including complex, multicenter, and global studies.
Strong vendor management and CRO oversight skills: selection, contracting, KPI development, governance, and performance escalation.
Expertise in study start-up processes: site selection, feasibility, contracting, budgeting, and investigator site initiation.
Proficiency with clinical systems and tools: CTMS (e.g., Veeva), eTMF, EDC (e.g., Medidata Rave, Oracle InForm), RBM/RBQM platforms, safety databases (Argus/ArisGlobal), and ePRO/eConsent solutions.
Experience managing IND/CTA submissions, clinical regulatory documentation, and supporting regulatory filing packages (NDAs/MAAs).
Budget development and financial management for multi-study portfolios, including forecasting, burn rate analysis, and contract negotiation.
Solid understanding of biostatistics concepts, data management life cycle, CRF/eCRF design and database lock processes.
Knowledge of pharmacovigilance processes and SAE/AE management, including expedited reporting and safety signal management.
Experience implementing decentralized clinical trial strategies, hybrid trial models, and patient-centric enrollment tactics.
Familiarity with quality systems, CAPA processes, audit management and remediation related to clinical trial operations.
Proven track record of meeting enrollment targets and operational milestones in competitive therapeutic areas (e.g., oncology, CNS, rare disease, immunology).

Soft Skills

Strategic leadership and vision with the ability to operationalize strategy into clear, actionable study plans and deliverables.
Strong cross-functional collaboration and stakeholder management skills; able to influence senior leaders, KOLs and external partners.
Excellent written and verbal communication skills, including the ability to prepare executive summaries, board-level reports and regulatory responses.
Problem-solving orientation with a bias for action and data-driven decision making.
High emotional intelligence with demonstrated team-building, mentoring and talent development capabilities.
Adaptability and resilience in fast-paced, ambiguous environments and during regulatory or operational crisis management.
Superior organizational skills, prioritization, and attention to detail to manage multiple high-stakes projects concurrently.
Negotiation and conflict-resolution skills for managing vendors, sites and cross-functional disputes.
Customer/patient-centric mindset focused on improving patient recruitment, retention and experience.
Ethical judgment, confidentiality, and commitment to patient safety and data integrity.

Education & Experience

Educational Background

Minimum Education:

Bachelor's degree in Life Sciences, Nursing, Pharmacy, Medicine, Public Health, or related scientific discipline.

Preferred Education:

Advanced degree preferred (MS, MPH, PharmD, MD, or PhD) in a clinical, scientific or healthcare discipline.

Relevant Fields of Study:

Clinical Research, Nursing, Medicine
Pharmacy, Pharmacology
Public Health, Epidemiology
Life Sciences, Biology
Biostatistics or Health Economics (advantageous)

Experience Requirements

Typical Experience Range: 10–15+ years in clinical research and clinical operations, with at least 5+ years in a management or leadership role overseeing clinical trials.

Preferred:

12+ years of progressive clinical operations experience, including leadership of global, multi-site phase II–III/IV trials.
Direct experience managing CROs and large cross-functional teams, oversight of complex therapeutic area programs (e.g., oncology, rare disease, immunology).
Track record of successful regulatory interactions and inspection readiness.
Experience with decentralized trials, digital health integrations, and modern trial designs is highly desirable.