Clinical Trial Leader

About the Role

The Clinical Trial Leader (CTL) is accountable for the set-up, execution, and delivery of assigned clinical trials, contributing to the client’s pipeline through accurate planning and efficient execution. The CTL provides leadership to the trial team (core and extended members) and ensures the overall success and delivery of the trial according to defined milestones and key performance indicators. Responsibilities include steering clinical trial activities, engaging with patients and sites, communicating with internal and external stakeholders, and managing risk mitigation on a global, multi-country, or regional basis.

Responsibilities

• Trial Preparation:
  • Accountable for accurate planning and operational feasibility of trial timelines, ensuring alignment across the trial team.
  • Supports development of trial-level documents (e.g., Statistics, Data Management, Study Physician, Medical Writing, Site Monitoring).
  • Verifies and provides input into country allocation and oversees trial feasibility.
  • Develops and implements trial-level engagement plans, recruitment strategies, and risk mitigation.
  • Leads development of core trial and patient-facing documents, integrating patient/site feedback.
  • Frontloads activities at the trial level and cascades them to the country level for efficiency.
  • Oversees outsourcing of vendor services, including vendor identification, selection, and scope of work.
  • Ensures all required trial processes (e.g., clinical quality monitoring, safety reporting, investigational medicinal product, trial budget, site monitoring) are in place to meet milestones.
  • Aligns and supports team members in responding to questions from Regulatory Authority/Ethics Committee and other external stakeholders.
  • Provides or supports study-specific and standardized training for internal and external partners.
• Trial Conduct:
  • Maintains oversight of clinical trial conduct, ensuring adherence to GCP, global/local regulatory requirements, SOPs, and continuous risk monitoring/mitigation.
  • Collaborates with other functions to ensure budget oversight, clinical quality monitoring, Safety Management Committee (SMC)/Data Management Committee (DMC) management, and safety reporting.
  • Prepares and implements amendments to core documents, including training material updates/retraining as needed.
  • Supports responses to authority/ethics requests.
  • Oversees outsourcing of vendor services (e.g., central lab) in conjunction with other functions.
  • Monitors progress of patient recruitment and accrual of endpoints, proactively updating and actioning contingencies.
  • For early clinical trials, coordinates and harmonizes Innovation Unit tasks (e.g., biomarker sampling, genomics, sub-studies).
• Trial Closeout and Reporting:
  • Ensures timely cleaning and delivery of clinical trial data in collaboration with other functions.
  • Coordinates and supports the Trial Medical Writer in providing the Clinical Trial Report (CTR).
  • Responsible for timely, complete, and compliant archiving of all relevant global documents in the TMF, including vendor documents.
  • Supports results/documents disclosure in global registries and may assist in the publication of trial data.
• Contributions to Trial Strategy:
  • Supports preparation and execution of clinical trials, including planning milestones, contributing operational/scientific expertise, and preparing for regulatory interactions.
  • Supports the Clinical Development and Operations Lead (CDOL) in escalating issues to the client’s Evidence team for timely action or mitigation.
  • Responsible for Trial Feasibility activities defining key aspects of the Clinical Trial Protocol (CTP).
• Leadership Competencies:
  • Creates an environment that inspires, motivates, and empowers colleagues, promoting the client’s Clinical Development and Operations (CD&O) identity.
  • Fosters a learning culture by encouraging continuous learning, sharing best practices, and learning from failures.
  • Embraces innovative technologies and drives empowerment, smart risk-taking, and the CD&O identity.
  • Complies with Parexel standards, including required training, timesheet accuracy, expense reporting, CV updates, and adherence to processes, ICH-GCP, and applicable requirements.

Requirements

• University degree (bachelor’s or advanced) with a major focus in Biomedical Life Sciences.
• Extensive experience in clinical trial project management in an international context.
• Strong understanding of project management with an emphasis on teamwork to promote high-performance teams.
• Experience in Therapeutic Areas relevant to the client’s pipeline is desirable.
• Understanding of major regulations (US FDA, EMA, PMDA).
• Familiarity with guidelines and standard of care is desirable.
• Cross-geographical experience, including working in a multi-cultural environment and understanding corporate culture and cross-cultural dynamics.
• Strengths in mentoring/coaching.
• Demonstrated competencies in Agility, Accountability, and Intrapreneurship: fast decision-making, flexibility, ownership, outcome-based thinking, results orientation, and smart risk-taking.

Skills

• Strong Communication Skills: Articulates and aligns business strategy/plan, demonstrates active listening skills, and cultural awareness.
• Scientific and Operational Expertise: Demonstrates scientific and therapeutic knowledge and operational expertise across all aspects of clinical trial planning and execution, including protocol, patients, sites, countries, and vendors.
• Leadership and Influence: Addresses complex situations, sets direction for teams, supports/connects/empowers teams, and inspires them to achieve common goals with a focus on delivering value to patients.
• Strategic Mindset: Future-focused, creative, and courageous thinker who navigates ambiguity, integrates study strategy with the overall TA portfolio, and embraces cross-functional initiatives.
• Coordination and Oversight: Collaborative leader who sets priorities, manages the pace of activities, and uses resources efficiently.
• Project Management: Plans effectively, sets priorities, defines actions, uses resources proactively, and strives for transparency to accomplish deliverables. Translates complex situations into actionable parts and anticipates/resolves challenges.