Position Summary:
We are looking for an experienced and Sr. Clinical Data Management (CDM) Consultant.
This role involves managing Clinical Research Organizations (CROs) to ensure adherence to timelines, processes, and data review standards.
Key Responsibilities:
- Provide CRO oversight to ensure compliance with data management processes and timelines.
- Ensure high-quality data review and monitoring, with an emphasis on process improvement and timely delivery.
- Lead and manage the collaboration with CROs utilizing their EDC systems (INFORM, RAVE, MEDRIO, etc).
- Drive quality control measures for clinical data, including data review and data reconciliation.
- Offer strategic direction and hands-on guidance to ensure efficient data management operations.
- Collaborate with cross-functional teams to optimize the use of clinical trial data for oncology studies.
- Focus on solid tumor studies and apply RECIST (Response Evaluation Criteria in Solid Tumors) experience to ensure robust data collection and analysis.
Requirements:
- Experience: 8–10 years of Clinical Data Management experience, with a senior-level focus.
- Oncology Expertise: Strong experience in managing data for solid tumor studies, with a deep understanding of RECIST criteria.
- Sponsor Experience: Prior experience working directly with a sponsor company.
- CRO Oversight: Proven track record in managing and providing oversight to CROs.
- EDC Systems Proficiency: Hands-on experience with EDC systems such as INFORM, RAVE, MEDRIO and others.
- Consulting Experience: Ability to work in a part-time consulting role, providing high-level strategic input and direction to the CDM team.
