Clinical Research Associate Lead - Oncology H/F Excelya

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This is an exciting opportunity for an experienced Clinical Research Associate Lead specializing in Oncology to contribute to a dynamic team in Clinical Operations. You will play a crucial role in innovating clinical research practices in the oncology field, making a significant impact on the lives of patients.

Main Responsibilities

- Lead and oversee the full clinical site lifecycle for oncology studies (initiation, activation, monitoring, close-out) across all participating centers.
- Draft critical study documents like the Oncology Monitoring Plan, site manuals, and patient management guidelines.
- Supervise and mentor a team of Clinical Research Associates (CRAs), ensuring their professional development and effective monitoring practices.
- Ensure adherence to regulatory and operational compliance aligned with oncology protocols, SOPs, and ethical guidelines.
- Utilize tools such as the Clinical Trial Management System (CTMS) and ensure the integrity of the Trial Master File (TMF) for oncology studies.
- Manage site communications, providing updates on study progress, recruitment status, and protocol modifications specific to oncology.
- Contribute to oncology-specific study setup activities including database design, risk assessments, and resource planning.
- Participate in centralized medical monitoring and review oncology-related protocol deviations and risks.
- Lead final close-out efforts: quality checks, visit planning, and data archiving for oncology trials.
- Collaborate cross-functionally within the organization and participate actively in departmental meetings related to oncology research.