Senior Clinical Trial Management Associate
Job Title : Senior Study Management Associate (Oncology Experience Required)
Location : South San Francisco, CA (Onsite 3 days per week)
Our client is a trailblazer in the field of oncology, committed to advancing cancer care and improving patient outcomes. With a dedicated team at the forefront of groundbreaking research, they are focused on bringing innovative therapies to market.
As they expand their efforts and continue to drive progress in oncology, they are seeking a talented and experienced Senior Study Management Associate to join their dynamic team.
Key Responsibilities Overview :
Study Management : While collaborating with the Clinical Trial Manager, oversee and manage all aspects of clinical trials, including study planning, execution, and closeout.
Ensure adherence to study protocols, regulatory requirements, and company standards.
Oncology Expertise : Utilize your in-depth knowledge of oncology to support study design, patient recruitment, and data analysis.
Collaborate with cross-functional teams to address oncology-specific challenges.
Regulatory Compliance : Ensure that all clinical activities comply with FDA regulations, ICH-GCP guidelines, and other relevant standards.
Prepare and review regulatory documents, submissions, and reports.
Vendor and Site Management : Coordinate with external vendors and clinical sites to ensure timely and accurate execution of study activities.
Address any issues that arise and facilitate effective communication.
- Data Management : Oversee data collection, entry, and validation processes. Ensure data integrity and accuracy throughout the study lifecycle.
- Team Collaboration : Work closely with project managers, clinical research associates, and other team members to ensure alignment and effective execution of study goals.
Qualifications :
- Minimum of 5 years of experience in clinical study experience with a strong emphasis on oncology studies.
- Bachelor’s degree in life sciences, nursing, or a related field. Advanced degree or certification (e.g., Clinical Research Coordinator or Clinical Research Associate) is a plus.
- Ability to work onsite 3 days per week in South San Francisco. Flexibility to accommodate project needs and occasional travel as required.
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