Position Summary:
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 team 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.
Principal Responsibilities:
- 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.
Principal Relationships:
Internal: DAS Leaders, Trial Management Directors, Clinical Trial Managers, Clinical Trial Assistants, representatives of Delivery Operations, representatives of other GD Functions and Clinical Teams
External: Investigators Education and Experience Requirements: Required Minimum
Education:
BS degree or equivalent, preferred areas of study include Life Sciences (Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
Required Years of Related Experience:
Minimum of 8 years in Pharmeceutical, Healthcare or related industries
Required Knowledge, Skills and Abilities:
- 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.
- 2-3 years' experience leading multiple aspects of a global clinical trial
- Must possess excellent leadership skills and proven ability to foster team productivity and cohesiveness.
- Experience of leading without authority and in muti-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.