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Why join Freenome?
Freenome is a rapidly expanding biotech company that creates tests to detect cancer using standard blood samples. The company uses a multiomics platform that merges both tumor and non-tumor signals with machine learning to find cancer at its earliest and most treatable stages.
Despite cancer's tenacity, Freenome is amassing clinical, economic, and operational evidence to advance cancer screening and save lives. Our inaugural screening test focuses on colorectal cancer (CRC) and advanced adenomas, but this is just the beginning.
Founded in 2014, Freenome has around 500 employees and over $1.1 billion in funding from significant investors like 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 strive to influence patient outcomes by enabling everyone to prevent, detect, and treat their disease. This aim, coupled with our high-performing culture of respect and cross-collaboration, motivates us to make the most of every day.
About this opportunity:
We are looking for a highly driven Clinical Data Manager to supervise and manage the data from our clinical trials. The Clinical Data Manager will be in charge of handling the clinical data throughout the entire clinical trial, ensuring the data's precision and integrity, and cleaning and transferring clinical data in clinical studies. You will ensure that all data management activities comply with GCP, regulatory requirements, and study-specific protocols. As part of the Clinical Development Team, you will collaborate with others to ensure the success of Freenome's clinical studies. Moreover, you will collaborate with other Freenome teams to provide recommendations on how to utilize the clinical data.
What you'll do:
- List the job responsibilities that are important and impactful for this role
- Develop and maintain data management plans and procedures in line with GCP, regulatory requirements, and study-specific protocols
- Ensure that all data management activities (including study data) are collected, processed, and stored in accordance with GCP, regulatory requirements, and study-specific protocols
- Design the case report forms (CRFs) with the medical and clinical operations team following the clinical protocol and study data requirements
- Serve as the expert in offering 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 carry out data validation activities
- Manage and conduct data cleaning and query resolution activities to ensure data is of high quality and accurate
- Develop and maintain relationships with key stakeholders, such as study sites, CROs, and other vendors
Must haves:
- Bachelor's or higher degree 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 implementation and testing
- Good knowledge of GPC, ICH guidelines, and regulatory requirements and guidelines related to clinical data management
- Experience in CRO communications, oversight, and management
- 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 more information about the company.
Freenome is proud to be an equal opportunity employer, and we value diversity. We do not discriminate based on 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.
Applicants have rights under Federal Employment Laws.
- Family & Medical Leave Act (FMLA)
- Equal Employment Opportunity (EEO)
- Employee Polygraph Protection Act (EPPA)
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