Clinical Data Manager (Contractor)

Why join Freenome?

Freenome is a high-growth biotech company developing tests to detect cancer using a standard blood draw. To do this, Freenome uses a multiomics platform that combines tumor and non-tumor signals with machine learning to find cancer in its earliest, most-treatable stages. 

Cancer is relentless. This is why Freenome is building the clinical, economic, and operational evidence to drive cancer screening and save lives. Our first screening test is for colorectal cancer (CRC) and advanced adenomas, and it’s just the beginning. 

Founded in 2014, Freenome has ~500 employees and more than $1.1B in funding from key investors, such as the American Cancer Society, Andreessen Horowitz, Anthem Blue Cross, Bain Capital, Colorectal Cancer Alliance, DCVC, Fidelity, Google Ventures, Kaiser Permanente, Novartis, Perceptive Advisors, RA Capital, Roche, Sands Capital, T. Rowe Price, and Verily.  

At Freenome, we aim to impact patients by empowering everyone to prevent, detect, and treat their disease. This, together with our high-performing culture of respect and cross-collaboration, is what motivates us to make every day count.

About this opportunity:

We are seeking a highly motivated Clinical Data Manager to oversee and manage the data from our clinical trials. The 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, making sure of 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. Additionally, You will work with other teams in Freenome to provide recommendations about how to use the clinical data. 

What you’ll do:

• List the job responsibilities that is important and impactful for this role
• 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

Must haves:

• Bachelors or higher education in science (biological or computer) and/ or clinical informatics related disciplines and at least (5) years of industry clinical data management experience
• Strong experience with multiple EDC systems (Medio, RedCapCloud, or similar) including implementing and testing
• Good knowledge of GPC, ICH guidelines, regulatory requirements and guidelines related to clinical data management
• Experience in CRO communications, oversight, and management by working effectively both in a core team and functional team settings
• Excellent problem-solving and critical-thinking skills 
• Strong business acumen and ability to work effectively across a multi-disciplinary team

Nice to haves:

• Programming and data analysis experience

Additional information:

Contractors may be hired through a third-party provider and will be considered contingent workers. We invite you to check out our career page @ https://careers.freenome.com/ for additional company information.  

Freenome is proud to be an equal opportunity employer and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

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