At a Glance
- Tasks: Lead the execution of clinical trials and manage vendor activities for successful study delivery.
- Company: Join a leading pharmaceutical company dedicated to innovative healthcare solutions.
- Benefits: Competitive salary, travel opportunities, and professional development in a dynamic environment.
- Other info: Mentorship opportunities and a chance to work in a global team.
- Why this job: Make a real impact in clinical research while developing your leadership skills.
- Qualifications: BS in Life Sciences and 4+ years of clinical trial experience required.
The predicted salary is between 60000 - 80000 £ per year.
Job Description
The Lead, Trial Delivery Management (TDM) is responsible for the execution of study-level activities, creating and updating trial-specific documents, vendor oversight and delivery, compound training, and other activities.
The TDM oversees country and regional operational delivery, aligning the feasibility strategy and target setting, conducting risk reviews, and addressing local challenges that could impact overall study delivery.
- 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 day‑to‑day study vendor activities, including set‑up, SOW creation, and budget oversight.
- Coordinate country and regional trial management activities, aligning feasibility strategy with local teams and performing country‑level risk reviews.
- Develop program‑level compound training in collaboration with Clinical, CTL&D, and 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, and cross‑DU level.
- Support Health Authority inspections and identify risks and mitigation plans at the program level for key issues.
- Mentor and support onboarding of new team members, particularly those in Trial Management.
Education And Experience Requirements
BS degree or equivalent in Life Sciences (e. g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
Minimum of 4 years’ clinical trial experience in Pharmaceutical, Healthcare or related industries.
- Required Knowledge And Experience
- Clinical research operational knowledge and experience across multiple phases of studies (Phase I‑IV); ability to manage multiple aspects of a clinical trial.
- 2‑3 years’ experience supporting multiple aspects of a global clinical trial.
- Excellent leadership skills and proven ability to foster team productivity and cohesiveness.
- Experience leading without authority in multi‑functional, matrixed and global environments.
- Excellent decision‑making, analytical and strong financial management skills.
- Operate and execute with limited supervision; experience mentoring/coaching others.
- Strong project planning, management, communication and presentation skills.
- Other
Percentage of travel: up to 15‑20% of the time, defined by business needs.
- Preferred Related Industry Experience
- Pharmaceutical
- Biopharmaceutical
- Biotechnology
- Preferred Skills
- Analytical Reasoning
- Clinical Research and Regulations
- Clinical Trial Designs
- Clinical Trial Management Systems (CTMS)
- Clinical Trials
- Communication
- Data Savvy
- Laboratory Operations
- Organizing
- Problem Solving
- Productivity Planning
- Professional Ethics
- Project Integration Management
- Quality Assurance (QA)
- Regulatory Compliance
- Research and Development
- Research Ethics
- Standard Operating Procedure (SOP)
- #J-18808-Ljbffr
Contact Details:
Johnson & Johnson Innovative Medicine Recruitment Team
