Clinical Trial Manager
2 weeks ago
Job Summary:
We are seeking an experienced Clinical Trial Manager to join our Clinical Operations team at i-Pharm Consulting. The successful candidate will be responsible for overseeing the execution of Phase I - IV clinical trials across various therapeutic areas, with a particular focus on solid tumour oncology clinical trials.
Key Responsibilities:
- Study Management: Manage all aspects of small clinical studies, including Phase I trials, and oversee multiple components of larger studies.
- CRO and Vendor Management: Lead the selection and management of CROs and vendors, ensuring all deliverables are met.
- Operational Oversight: Act as the key operational contact, providing oversight for site evaluation, initiation, monitoring, and close-out visits, either directly or through CROs.
- Study Logistics and Planning: Develop study logistics and clinical study plans to achieve study objectives, including managing timelines, documentation, and communications.
- Problem Solving: Identify potential operational challenges and collaborate with the team to provide solutions to keep studies on track.
Requirements:
- Educational Background: PharmD/PhD with 2+ years, MA/MS with 3+ years, or BA/BS/RN with 5+ years of relevant clinical experience in life sciences.
- Experience in Oncology Trials: Solid experience in solid tumour oncology clinical trials, and familiarity with PFS, OS analysis, imaging management, and ePRO.
- Clinical Operations Expertise: Strong knowledge of study management best practices, GCP guidelines, and regulatory requirements (FDA, EMA, ICH).
- Communication Skills: Excellent ability to communicate clearly and work within a team-oriented environment.
About i-Pharm Consulting:
i-Pharm Consulting is a leading bio-pharmaceuticals company dedicated to delivering high-quality data and innovative solutions in clinical operations. We are committed to excellence and strive to make a positive impact in the pharmaceutical industry.
How to Apply:
To apply, please submit your CV outlining your qualifications and experience relevant to this role.
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