Clinical Data Manager

About the Opportunity:

We are partnering up with fast-growing biotech based in the Bay Area. They're developing ground breaking therapies focused in oncology and autoimmune.

We are looking for an experienced and talented professional to ensure the delivery of accurate, high-quality clinical trial data across one or more clinical trials. This role is ideal for a motivated, self-starter who thrives in a collaborative environment, working seamlessly with internal teams and external partners to achieve clinical study objectives and corporate goals. While local candidates are preferred, remote candidates willing to travel occasionally will also be considered.

Role and Responsibilities:

• Oversee clinical data management activities for multiple studies.
• Develop, co-develop, and maintain clinical data management documents in collaboration with CROs, including Data Management Plans, Case Report Forms (CRFs), CRF Completion guidelines, edit check specifications, data transfer specifications, and report specifications.
• Manage and oversee DM CRO data management activities.
• Partner with CROs and EDC vendors to ensure timely design and development of clinical study databases, including system integrations.
• Organize and conduct cross-functional User Acceptance Testing (UAT) for clinical databases and integrations.
• Review clinical study documents such as Clinical Protocols, Data Transfer Specifications/Agreements, Study Plans, and Project Timelines.

Education, Experience, and Qualifications:

• Bachelor’s degree in clinical, biological, or mathematical sciences (advanced degree preferred).
• Minimum of 5 years of clinical data management experience in the biopharmaceutical industry on the Sponsor side.
• Advanced knowledge of Data Management processes and systems.
• Strong understanding of clinical drug development processes.
• Minimum of 5 years of experience in Autoimmune, Hematology-Oncology, and/or Oncology.
• Minimum of 5 years of experience with Electronic Data Capture (EDC), preferably Medidata Rave X; IXRS integration experience required.

Core Competencies, Knowledge, and Skills:

• Highly motivated self-starter.
• Team player with strong interpersonal skills, able to work effectively at all organizational levels.
• Demonstrable leadership skills.
• Ability to work under pressure and meet timelines.
• Proficient in managing multiple priorities and rapidly assimilating and disseminating information.
• Detail-focused with strong technical/scientific management abilities.