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Salary not available. View on company website.
Johnson & Johnson, Terriers, Wycombe
- Onsite working
- Full time
- Permanent
Posted 1 week ago, 1 Jun
Job ref: 12855e9985ea43a983eb355e9e2ce61b
Full Job Description
The Medical Affairs - Delivery Unit, Lead, Trial Delivery Manager (TDM) is responsible for the execution of study-level activities, creating and updating trial-specific documents, vendor oversight & delivery, compound training, and other activities. The TDM is responsible for country and regional oversight of local operational delivery, including the alignment of the feasibility strategy and target setting, risk reviews and local challenges that could impact overall study delivery. The TDM might have responsibilities cross different trial types (such as Company Sponsored, Investigator Initiated, and Collaborative Studies), within different Therapeutic Areas, in a local, regional, or global setting, depending on the business need. Principal Responsibilities:
- Create and update critical trial-specific documents (e.g., Monitoring Guidelines, Informed Consent Form, Investigational Medicinal Product [IMP] related documentation).
- Manage vendor set up and management of day-to-day study vendor activities, including set-up, SOW
- creation and budget oversight.
- Responsible for country / regional coordination of trial management activities and oversight (e.g., aligns feasibility strategy with local teams, perform country-level risk reviews, aware of all projects conducted across countries).
- Support development of program-level compound training, collaborating with Clinical / CTL&D / Medical
- writing.
- Provide input into trial level operational strategies.
- Resolve trial-related issues and mitigate trial-related risks.
- Participate in process improvement activities at a trial, compound & cross-DU level, as needed.
- Provide support 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
BS degree or equivalent, preferred areas of study include Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy) - Minimum of 4 years clinical trial experience in Pharmaceutical, Healthcare or related industries.
- Clinical research operational knowledge and experience across multiple phases of studies (Phase I-IV); must have the ability to manage multiple aspects of execution of a clinical trial.
- 2-3 years' experience supporting global clinical trials.
- Excellent leadership skills and proven ability to foster team productivity and cohesiveness.
- Experience 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.
- Ability to support and participate in the hiring, training, development, and evaluation of staff on a regular basis.
- Strong project planning/management, communication and presentation skills are required. Other:
- Travel up to 15-20% of the time, defined by business needs.
- Preferred Related Industry Experience: Pharmaceutical, Biopharmaceutical, Biotechnology