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Clinical Project Director Job Summary
hace 2 semanas
Clinical Project Director Job Summary
We are seeking a highly skilled Clinical Project Director to oversee clinical trials from initiation through to completion, ensuring that the project remains on track in terms of timelines and regulatory requirements.
This role will involve managing project strategy and execution without direct line management responsibility. The CPD will work closely with cross-functional teams and stakeholders to ensure the delivery of clinical projects within scope and regulatory guidelines.
Key Responsibilities:
- Lead and manage clinical projects from inception to completion, ensuring adherence to timelines and quality standards.
- Main point of escalation for clinical project-related matters.
- Develop and implement clinical project plans, timelines, and resource allocation strategies.
- Collaborate with internal teams (clinical operations, regulatory, quality, data management) and external stakeholders (CROs, investigators, vendors) to ensure project success.
- Provide guidance and oversight for the execution of clinical trials, ensuring compliance with regulatory guidelines (e.g., ICH-GCP, FDA, EMA).
- Identify project risks, and proactively develop and implement mitigation strategies.
- Monitor and report on project progress, key milestones, and performance metrics to senior management and stakeholders.
- Manage external vendors and service providers to ensure delivery of contracted services on time.
Qualifications:
- Bachelor's degree in life sciences or equivalent experience; advanced degree preferred.
- Extensive experience in clinical research, particularly in project management of clinical trials.
- Strong knowledge of clinical development processes, ICH-GCP, and relevant regulatory requirements.
- Proven ability to manage multiple projects simultaneously with strong organizational and communication skills.
- Experience with clinical trial management software and project management tools.
