Senior Manager, Trial Delivery Leader

Role Description

The Sr. Manager, Trial Delivery Leader (TDL) is accountable for clinical trial delivery, providing operational oversight of cross-functional deliverables. The TDL leads a cross-functional trial team to build and deliver the trial operational plan, identifying and mitigating risks to effectively deliver assigned trials on time, on budget and in a compliant manner.

• Responsible for leading the Cross Functional Trial Team (CFTT) to influence and execute delivery of the operational plan and for end-to-end trial execution.
• Accountable for overall trial delivery, budget, timelines, quality, and milestones (e.g., support DBL / CSR / TLR planning and scope, define protocol deviations and resolution pathways).
• Proactively ensure that trial deliverables and milestones are met.
• Identify risks and ensure mitigation and contingencies are being initiated and followed through.
• Ensure trial is operationalized in compliance with global health authority regulations and guidelines and internal operating procedures and processes.
• Accountable for identifying risks in study conduct, developing mitigation plans and escalating concerns to the CT or CDT.
• Participate in preparation for, and conduct of, Health Authority inspections and internal QA audits.
• Ensure that the trial team operates in a constant state of inspection-readiness, collaborating with R&D Quality to ensure quality oversight.
• Participate in process improvement activities at a trial, compound & cross-DU level, as needed.

Additional Responsibilities may Include:

• Lead and ensure inspection readiness for program through risk identification and readiness review.
• Provide leadership during Health Authority inspections and on the identification of risks and mitigation plans at the program level for key issues.
• Mentor & support onboarding of new team members, particularly those in Trial Management.
• Foster employee engagement, inclusion, and Credo Behaviors.

Qualifications

• Bachelor's degree is required. Preferred areas of study include Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
• Minimum of 8 years in Pharmaceutical, Healthcare or related industries.
• Minimum 2 years’ experience leading multiple aspects of a global clinical trial.
• Experience in and knowledge of the pharmaceutical development process.
• Clinical research operational knowledge and experience across multiple phases of studies (Phase I-IV); must have the ability to manage all aspects of execution of a clinical trial.
• Must possess excellent leadership skills and proven ability to foster team productivity and cohesiveness.
• Experience of leading without authority and in multi-functional matrixed and global environments.
• Excellent decision-making, analytical and strong financial management skills are essential to this position.
• Operate and execute with limited supervision.
• Experience mentoring/coaching others.
• Strong project planning/management, communication and presentation skills are required.
• Travel up to 15-20% of the time, defined by business needs.

Requirements

• Budgeting
• Clinical Trial Designs
• Clinical Trials
• Compliance Management
• Consulting
• Contract Management
• Execution Focus
• Fact-Based Decision Making
• Give Feedback
• Industry Analysis
• Laboratory Operations
• Organizing
• Process Improvements
• Project Integration Management
• Research and Development
• Research Ethics
• Technical Credibility