Global Clinical Trial Leader

Job Description

Job Summary:

• The Client Global Clinical Trial Leader (CTL) is accountable for the execution and delivery of early development global clinical trials under the leadership of the Sr. CTL.
• These complex programs focus on the rapid development of new molecular entities with limited or no clinical data, requiring the implementation of Client and highly flexible global operational strategies.
• The CTL actively contributes to the Protocol Execution Team (PET), manages vendors, develops risk mitigation strategies, and champions change related to study assignments and department goals.

Duties & Responsibilities:

Study Execution & Team Collaboration:

• Operational Expertise: Provide operational guidance to one or more global cross-functional Protocol Execution Teams (PETs) across all study stages (start-up, conduct, and close-out).
• Culture & Leadership: Foster a positive work environment built on mutual respect, innovation, and accountability at both local and global project levels.
• Trial Documentation: Drive and finalize cross-functional activities ensuring the quality delivery of vendor specifications, drug supply forecasting, monitoring/communication plans, Trial Master Files (TMF), and CTMS data.
• Stakeholder Alignment: Collaborate with cross-functional members on study plans and coordinate effective investigator meetings.

Vendor & Budget Management:

• Vendor Oversight: Participate in vendor selection alongside the PETL; oversee outsourced activities to ensure CROs and vendors deliver strictly aProductst contracted Products of work.
• Financial Input: Provide strategic input into the overall study budget and directly manage assigned vendor budgets.

Strategic Planning & Strategy:

• Feasibility & Design: Contribute to country and site selection, assist in developing clinical trial protocols/informed consents, and provide operational input on protocol feasibility.
• Risk & Timeline Management: Apply critical thinking to manage timelines, identify bottlenecks, and propose actionable resolutions.
• Patient Centricity: Maintain a patient and site-centric mindset across all trial activities and interactions.

Contributing to the Wider Client Community:

• Process Improvement: Partner with Client and pan-Client colleagues to establish operational best practices and enhance clinical trial execution across the organization.
• Subject Matter Expertise: Serve as a Subject Matter Expert (SME) or client single point of contact for Clients functional initiatives.
• Mentorship: Coach, mentor, and share expertise to support the development of junior staff and peers.

Experience, Skills & Attributes:

• Core Philosophy: A successful candidate is a developing leader who exhibits a high degree of curiosity, a growth mindset, and a strong customer focus where the patient is always the ultimate customer.

Technical & Professional Experience:

• Early Phase Expertise: Proven experience managing delegated aspects of global, complex Phase I and II clinical studies.
• Vendor Management: Demonstrated success effectively managing a diverse portfolio of vendors and CROs.
• Risk & Strategy: Adept at identifying, assessing, and proactively mitigating operational risks using quantitative and qualitative data.

Leadership & Soft Skills:

• Communication & Influence: Excellent communication skills with the ability to independently deliver key messages to stakeholders, influence teams, and negotiate to achieve shared goals.
• Problem Solving: Creative problem solver who welcomes diversity of thought to navigate through ambiguity and resolve issues.
• Adaptability: Highly flexible, solution-focused, and self-aware, exercising excellent judgment on when to seek guidance.
• Change Champion: Consistently advocates for and supports organizational change to positively impact the business.

Qualifications & Requirements:

• Education: Bachelor’s degree or equivalent required (scientific or healthcare discipline preferred).
• Experience: 8+ years of clinical study management experience desired.
• Knowledge: Working knowledge of GCP/ICH requirements, international regulatory guidelines, and the end to end drug development process.
• Travel: Some travel may be required.

Interview Format:

• Two Rounds (1 – hiring manager phone screening [20 minutes]; 2 – Panel [on-site – 1 hour 30 minutes – where the candidates will interview with the panel for 45 minutes, then move into another meeting with a manager for the remaining 45 minutes]).