Position: Lead, Trial Delivery Management (TDM)
Location(s): High Wycombe, Buckinghamshire, United Kingdom; Spring House, PA, United States; Toronto, Canada; Beerse, Belgium; Milano, Italy; Madrid, Spain; Warsaw, Poland. (Multiple requisition numbers apply.)
Key Responsibilities
- Create and update critical trial‑specific documents (e.g., Monitoring Guidelines, Informed Consent Form, IMP related documentation).
- Manage vendor set‑up and day‑to‑day study vendor activities, including SOW creation and budget oversight.
- Coordinate country and regional trial‑management activities and oversee operational delivery, ensuring feasibility strategy alignment, risk reviews and addressing local challenges.
- Develop program‑level compound training in collaboration with Clinical / CTL&D / Medical writing.
- Contribute to trial‑level operational strategies and resolve trial‑related issues and risks.
- Participate in process improvement activities at trial, compound and cross‑DU level.
- Provide support during Health Authority inspections and develop risk mitigation plans at program level.
- Mentor and onboard new team members, particularly in Trial Management.
Education and Experience
- BS degree or equivalent; preferred fields: Life Sciences (Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
- Minimum 4 years of clinical‑trial experience in pharmaceutical, healthcare or related industries.
- 2‑3 years supporting multiple aspects of global clinical trials across Phase I‑IV.
- Leadership experience with ability to foster team productivity and cohesiveness; experience leading without authority in matrixed global environments.
- Excellent decision‑making, analytical, financial management, project planning/management, communication and presentation skills.
- Experience mentoring/coaching others.
Required Knowledge and Skills
- Clinical research operational knowledge across multiple phases of studies.
- Strong project planning/management, communication, and presentation skills.
- Financial management and resource allocation expertise.
- Analytical reasoning and problem‑solving.
- Knowledge of Clinical Trial Management Systems (CTMS), SOPs, QA, regulatory compliance.
Preferred Skills
- Analytical reasoning, clinical research and regulations, trial designs, CTMS, data savvy, laboratory operations, organizational, problem solving, productivity planning, professional ethics, project integration management, QA, regulatory compliance, research and development, research ethics.
Travel
Travel up to 15–20% of the time.
EEO Statement
Johnson & Johnson is an equal opportunity employer and encourages application from all qualified individuals regardless of race, colour, religion, gender, sexual orientation, national origin, veteran status, or disability status.
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