Position Overview: Jordan Griffiths is seeking an experienced Freelance Clinical Project Manager (CPM) specializing in early phase clinical trials. The ideal candidate will be responsible for the planning, execution, and management of early phase clinical studies, ensuring they are conducted in compliance with regulatory requirements and company standards. This role requires a highly organized and proactive individual with a strong background in clinical project management and early phase clinical trials.
Key Responsibilities:
- Project Planning and Management:
- Develop and manage comprehensive project plans, timelines, and budgets for early phase clinical trials.
- Coordinate and oversee all aspects of clinical trial execution, including site selection, initiation, monitoring, and close-out activities.
- Ensure adherence to project timelines and milestones, and proactively identify and mitigate risks.
- Regulatory Compliance:
- Ensure all clinical trials are conducted in compliance with ICH-GCP guidelines, regulatory requirements, and company SOPs.
- Prepare and review regulatory submissions, including clinical trial applications and amendments.
- Team Leadership and Collaboration:
- Lead cross-functional project teams, including clinical operations, data management, biostatistics, and regulatory affairs.
- Foster effective communication and collaboration among team members and stakeholders.
- Vendor Management:
- Identify, select, and manage external vendors, including CROs, laboratories, and other service providers.
- Negotiate contracts and ensure vendor performance meets project requirements.
- Data Management and Reporting:
- Oversee data collection, management, and analysis to ensure data integrity and accuracy.
- Prepare and present regular project status reports to senior management and stakeholders.
- Budget Management:
- Develop and manage project budgets, ensuring cost-effective use of resources.
- Monitor project expenditures and provide regular financial updates.
Requirements
Qualifications:
- Education:
- Bachelor’s degree in Life Sciences, Pharmacy, or a related field. Advanced degree (e.g., MSc, PhD) preferred.
- Experience:
- Minimum of 5 years of experience in clinical project management, with a focus on early phase clinical trials.
- Proven track record of successfully managing clinical trials from initiation to completion.
- Experience working with regulatory authorities and preparing regulatory submissions.
- Skills:
- Strong knowledge of ICH-GCP guidelines and regulatory requirements.
- Excellent project management and organizational skills.
- Effective leadership and team management abilities.
- Strong communication and interpersonal skills.
- Proficiency in clinical trial management software and Microsoft Office Suite.
- Fluency in English; proficiency in French is highly desirable.
•
Last updated on Aug 15, 2024