Key Responsibilities:
- Manage the implementation, execution, and conduct of clinical studies, including study plans, key milestones, timelines, and budgets.
- Oversee vendor selection and relationships to maintain study quality and compliance.
- Provide regular study updates and progress tracking to senior leadership.
- Identify potential study risks and implement effective mitigation strategies.
- Coordinate all study phases - from start-up and treatment to maintenance and close-out - ensuring projects stay on time and within budget.
- Ensure data integrity during collection, review, cleaning, and monitoring processes.
- Collaborate with cross-functional teams and operate independently to meet deliverables.
Qualifications:
- Bachelor's degree in Life Sciences or a related discipline.
- Minimum of 5 years' experience in clinical and drug development.
- Strong background in global clinical trial and CRO management, particularly in oncology.
- Early-phase trial management experience is a plus.
- Solid understanding of ICH GCP guidelines and FDA regulations.
- Proficient in MS Office (Word, Excel, PowerPoint) and experienced in technical writing.
- Exceptional communication, planning, and organizational skills.
- Proven ability to influence and collaborate with cross-functional clinical study teams.
- Willingness to travel internationally up to 25%.
