Senior Clinical Data Manager

We are seeking a highly motivated Senior Clinical Data Manager to oversee and manage the data from our clinical trials. The Senior Clinical Data Manager will be responsible for managing the clinical data through the whole clinical trial, including the implementation and execution of clinical data capture, ensuring the accuracy and integrity of the data, cleaning and transferring clinical data in clinical studies. You will ensure that all data management activities are completed in accordance with GCP, regulatory requirements, and study-specific protocols. You will be a member of the Clinical Development Team working collaboratively to ensure the success of Freenome’s clinical studies.

• Develop and maintain data management plans and procedures in accordance with GCP, regulatory requirements, and study-specific protocols.
• Ensure that all data management activities (including study data) is collected, processed, and stored in accordance with GCP, regulatory requirements, and study-specific protocols.
• Design the case report forms (CRFs) in collaboration with the medical and clinical operations according to clinical protocol and study data requirements. Ensure the eCRFs are properly built and rigorously tested through User Acceptance Testing (UAT).
• Serve as the domain expert in providing guidance to study teams on data management issues, including database design, CRF development, electronic data capture (EDC) system, and data cleaning.
• Develop and maintain data validation plans and perform ongoing data validation activities.
• Manage and execute data cleaning and query resolution activities to ensure that data is of high quality and accurate.
• Develop and maintain relationships with key stakeholders, including study sites, CROs, and other vendors.
• Partner with cross-functional team leads and stakeholders to generate datasets for analysis and reporting.

• Bachelors or higher education in science (biological or computer) and/or clinical informatics related disciplines
• At least five (5) years of experience in clinical data management
• Knowledge and experience in developing and maintaining data management plans and procedures
• Familiarity with Good Clinical Practice (GCP) and regulatory requirements
• Ability to design case report forms (CRFs) and ensure proper building and testing of electronic CRFs (eCRFs)
• Expertise in providing guidance on data management issues, including database design, CRF development, and electronic data capture (EDC) systems
• Proficiency in data validation and cleaning activities
• Strong relationship-building skills with key stakeholders, including study sites, CROs, and vendors
• Collaboration with cross-functional team leads and stakeholders to generate datasets for analysis and reporting.

• Base salary range of $128,000 - $195,000
• Pre-IPO equity
• Cash bonuses
• Full range of medical, financial, and other benefits depending on the position offered
• Equal-opportunity employer
• Value diversity
• No discrimination based on various factors
• Rights under Federal Employment Laws (FMLA, EEO, EPPA)