Principal Clinical Data Manager

Employer
Freenome
Location
South San Francisco, CA
Posted
Nov 04, 2021
Ref
5667612002
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Principal Clinical Data Manager 

 

As a Senior Clinical Data Manager at Freenome, you will lead the life cycle of Clinical Data Management, including the implementation and execution of clinical data capture, cleaning, and transfer in clinical studies. You will be a member of the Clinical Development Team working collaboratively to ensure that Freenome’s clinical studies are conducted successfully. Specifically, you will own the primary responsibilities of clinical data completion and integrity.

How you’ll contribute:

  • Serve as the domain expert in providing clinical data management and electronic data capture (EDC) expertise to support clinical studies 
  • Design the case report forms (CRFs) in collaboration with the medical and clinical operation team according to clinical protocol and study data requirements
  • Develop EDC specifications to implement the CRFs electronically and ensure that the developers, the vendor or CRO properly builds the clinical database system through User Acceptance Testing (UAT)
  • Provide oversight and management of clinical data management activities throughout the life cycle of a clinical study, including the support of site monitoring and query generation/resolution
  • Manage data transfers from the CRO and reporting at required intervals; manage database locking and archiving at the end of the clinical study or in collaboration with CRO as applicable
  • Coordinate creation of Data Management plan, CRF Completion Guidelines, Data Cleaning Guidelines, Data Transfer Plan, and other clinical data management related documents 
  • Partner with CRO, site, and EDC vendors to establish processes to ensure study deliverables are met and the data collection activities satisfy the clinical trial regulation and requirements 
  • Assist in generating datasets for QC, analysis and reporting by supporting the cross-functional team of different stakeholders.

What you’ll bring: 

  • Bachelors or higher education in science (biological or computer) related discipline , with at least ten (10) years of clinical data management experience in the industrial or CRO setting
  • Strong experience with multiple EDC systems, such as Medrio and RedCapCloud with programming abilities preferred
  • Experience with the implementation of EDC systems
  • Experience in CRO communications, oversight, and management by working effectively both in a core team and functional team settings
  • Knowledge of GCP, ICH Guidelines and use of good clinical data management practices
  • Strong analytical skills and business acumen
  • Demonstrated problem-solving skills

 

About Freenome

Freenome is on a mission to empower everyone with the tools they need to detect, treat, and ultimately prevent cancer. We have pioneered the most comprehensive multiomics platform for early cancer detection through a routine blood draw. By combining deep expertise in molecular biology with advanced computational biology and machine learning techniques to recognize disease-associated patterns among billions of circulating, cell-free biomarkers, we are developing simple and accurate blood tests for early cancer detection and integrating the actionable insights into health systems to operationalize a machine learning feedback loop between care and science.

Our recent $270 Million Series C brings our financing to over $500 million from investors, including; Bain Capital, Perceptive Advisors, RA Capital, Polaris Partners, Andreessen Horowitz, funds and accounts advised by T. Rowe Price Associates, Inc., GV (formerly Google Ventures), Roche Venture Fund, Kaiser Permanente Ventures, American Cancer Society’s BrightEdge Ventures, Data Collective Venture Capital, Novartis and Verily Life Sciences.

 

Our Science

Freenome is building technology to advance the understanding of cancer through multiple analytes derived from blood. These signals include cell-free DNA, methylation of cell-free DNA, cell-free RNA, circulating proteins, and immune profiling derived from thousands of prospective samples. By developing novel statistical learning methods and applying them to integrate various -omics datasets, Freenome is a leader in modeling specific biological mechanisms to capture disease-dependent signatures, including gene expression, immune response, tumor burden, the tissue of origin, and 3D chromatin structure.

By building comprehensive discovery datasets and modeling critical biological systems, Freenome is learning what biological changes are present within the blood between a variety of different disease states, including cancer, autoimmune disorders, infections, drug response, and aging. The synthesis of Freenome’s datasets, cross-functional technical expertise, and audacious mission to discover biological truth, we seek to improve the lives of millions through early detection and early treatment of disease.

 

Our Culture

Freenomers are technical, creative, visionary, grounded, empathetic, and passionate. We build teams around divergent expertise, allowing us to solve problems and ascertain opportunities in unique ways. Freenomers are some of the most talented experts in their fields, joining together to advance healthcare, one breakthrough at a time.

We value empathy, integrity, and trust in one another, and we respect the diverse perspectives of our colleagues and those we serve. We assume positive intent and give each other the benefit of the doubt with the firm belief that we are a team working toward the same objectives. We believe in empowering and supporting each other in a collaborative and dynamic environment.

 

What does a successful person look like at Freenome?

Those who thrive at Freenome prioritize, manage, and execute their own goals with ownership and alignment with those of the company. They embrace our values of empathy, integrity, striving for greatness, servant leadership, trust, and holding themselves and their team accountable to these values. They crave collaboration with brilliant minds from disparate fields of study and believe that hiring and mentorship are fundamental to our success. Above all, they welcome and provide constructive feedback and criticism, trusting in others’ good intentions, and being secure in knowing that embracing mistakes is the best way to learn and grow. For those who pursue challenges, understudied problems, and want the opportunity to see their work impact the lives of millions of people affected by cancer every year, there’s no better place to be than Freenome.

 

Freenome is proud to be an equal opportunity employer and we value diversity. Freenome does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any other basis covered by appropriate law.

 

Notice to agencies:

Our in-house Talent Acquisition Team manages all employment opportunities at Freenome. Agencies and independent recruiters must be approved as a vendor by Freenome’s Talent Acquisition team before submitting candidates to any Freenome employee.

We do not accept unsolicited resumes or biographies from agencies under any circumstances. Any unsolicited resumes sent to Freenome, including those sent to a Freenome email address or directly to Freenome employees, will be considered Freenome property. Freenome will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Freenome will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees.

Please do not contact Freenome employees directly. Compliance with this request will impact our decision to work with you.

If you would like to be considered for a vendor partnership with Freenome, please submit your company overview and terms of placement to talent@freenome.com. If there is an interest, we will contact you.