Join a pioneering clinical-stage oncology company dedicated to developing targeted treatments tailored to patients’ needs. As a Contract Study Lead, you’ll collaborate with a passionate team of experts, helping drive critical clinical trials to bring new hope to cancer patients.
Position Overview:
In this role, you will lead the Study Execution Team (SET) and oversee end-to-end clinical trial operations for early-phase oncology studies. Partnering with cross-functional teams—including Clinical Science, Data Management, Regulatory, and Biostatistics—you will ensure that study goals are achieved on schedule and within budget.
Key Responsibilities:
- Direct the SET to initiate and execute clinical trials, maintaining compliance with FDA, ICH/GCP, and company SOPs.
- Work with the SET to prepare RFPs, manage bid defence, and select CROs and other clinical partners.
- Supervise CROs and vendors, ensuring alignment with project objectives, timelines, and budget requirements.
- Develop, review, and finalize essential study documentation, including protocols, informed consent forms, case report forms, and study guidelines.
- Manage study budgets, contracts, financial forecasts, and ensure invoice accuracy.
- Support clinical systems such as CTMS, TMF, EDC, and IRT to streamline study activities.
- Conduct data reviews, generate queries, and oversee site management with the CRO.
- Monitor study metrics, proactively addressing challenges and implementing solutions for smooth project progression.
- Build and maintain effective working relationships with internal teams, CROs, external vendors, and research sites.
- Train site staff, vendors, and team members on study protocols and processes.
- Ensure inspection readiness for regulatory or quality audits.
Qualifications:
- Bachelor’s degree in Life Sciences or a related field with 8-10 years in clinical trial management and drug development.
- Strong background in global clinical study operations and oncology-focused vendor management, with an emphasis on FDA and ICH/GCP guidelines.
- Experience in early-phase oncology trials, ideally with a focus on precision medicine.
- A self-starter with a continuous improvement mindset who enjoys taking on new challenges.
- Outstanding organizational, analytical, and communication skills in a dynamic environment.
- A collaborative team player who values relationship-building and cross-functional teamwork.
- Detail-oriented with a knack for creative problem-solving and process improvement.
- Willingness to travel approximately 10% of the time.
This role offers a unique opportunity to make a meaningful impact in oncology precision medicine. If you’re passionate about advancing cancer care and thrive in a fast-paced, collaborative environment, we’d love to hear from you!
