Clinical Project Director (Project Oversight)
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, budget, 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, budgets, and quality standards.
- Main point of escalation
- 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 and within budget.
- Troubleshoot and resolve issues related to the project, escalating as needed.
Ensure accurate and timely documentation and reporting in accordance with clinical trial requirements.
- Act as the main point of contact for internal and external stakeholders on clinical project-related matters.
Qualifications:
- Bachelor’s degree in life sciences, health-related field, or equivalent experience; advanced degree preferred.
- Experience in Dermatology and rheumatology
- 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.
- Ability to lead and work collaboratively in cross-functional teams.
- Strong problem-solving and decision-making abilities.
Preferred Qualifications:
- Experience working with global teams and managing international clinical trials.
- This description ensures a clear emphasis on project oversight without directly managing a team, while still demonstrating leadership and cross-functional collaboration skills.
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