Job Title: Study Start Up Project Manager (RnD)
Job Function: Project Management
Therapy Area/Industry: Clinical Research
Job Description:
Proclinical is seeking a Study Start Up Project Manager to join the Clinical Trial Accelerator Unit (CTAU). In this role, you will be responsible for accelerating Study Start Up activities, harmonizing processes, and providing start-up expertise to ensure study teams meet and exceed timelines. You will work closely with the Clinical Trial Lead (CTL) to ensure all sites in the study are activated on time. This role involves oversight and collaboration to achieve timely and efficient deliverables, compliant with SOPs, local regulations, and international guidelines such as ICH and GCP.
Responsibilities:
- Build and manage MS Project plans for all activities, ensuring task-driven progress.
- Maintain the Quantitative Science and Development Operations (QSDO) study dashboard.
- Monitor individual site activations closely.
- Engage in Feasibility, Site Selection, Site contracting and budgets, Vendor set-up, and Informed Consent management.
- Support special projects, develop templates, materials, and processes as needed.
Key Skills and Requirements:
- Degree in a scientific discipline; advanced degree preferred.
- Strong project management skills with scientific and clinical knowledge.
- Good understanding of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
- Proficiency in MS Project and advanced use of MS Excel.
- Experience with Veeva CTMS and Study Start Up module is ideal.
- Clinical research experience with a focus on Study Start Up management.
- Organizational, time management, communication, interpersonal, and negotiation skills.
- Ability to work effectively in a matrix environment.
If you are having difficulty in applying or if you have any questions, please contact Dean Fisher at d.fisher@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
Proclinical Staffing is an equal opportunity employer.