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The Clinical Project Manager is responsible for the oversight and conduct of clinical research trials. They will ensure that trials are executed in accordance with applicable regulations and that the quality of clinical data generated meets the requirements for Regulatory Authority approval. This role provides both strategic and tactical operational planning and execution of all phases of clinical programs. This is a 2-year fixed term contract, offered on a fully remote basis across ProPharma’s European entities.
Key Responsibilities
- Partner with relevant internal functions to develop clinical study plans, including timelines and budgets.
- Prepare, or facilitate preparation of, essential study documentation (protocols, case report forms, informed consent forms, enrolment feasibility assessments, and other internal plans required for study conduct).
- Lead and actively participate in cross-functional team meetings.
- Prioritize tasks effectively to ensure project milestones are met or exceeded.
- Support site activities, including site identification, investigator meetings, site training, research agreements, and study budget negotiations.
- Oversee or conduct study monitoring: develop monitoring plans, manage resources, perform initiation visits, oversee interim visits, and closeout activities.
- Perform or oversee study closeout procedures, including completion of critical documentation, product disposition, and preparation of study sites for audits.
- Develop and maintain tracking systems as required for study management.
- Medical background with proven clinical experience.
- Minimum 2.5 years of Clinical Project Management experience, ideally in respiratory or cardiology studies.
- Strong knowledge of clinical research processes, ICH-GCP guidelines, and regulatory requirements.
- Experience in CRO and vendor management.
- Excellent organizational, leadership, and communication skills.
- Ability to work independently and manage multiple priorities in a remote, international environment
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
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