Senior Manager, Trial Delivery Leader

Johnson & Johnson Innovative Medicine•Spring House, PA

4d•Remote

About The Position

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.

Requirements

BS degree or equivalent, preferred areas of study include Life Sciences (Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
Minimum of 8 years in Pharmaceutical, Healthcare or related industries
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 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.

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.
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.