Clinical Trial Manager

Employer
Freenome
Location
South San Francisco, CA
Posted
Oct 06, 2021
Ref
5596247002
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Clinical Trial Manager

 

Freenome’s Clinical Trial Manager will support the successful design and day-to-day execution of clinical trials from concept through publication. Key accountabilities include the successful conduct of clinical studies consistent with applicable regulations, guidelines, and procedures and managing clinical project timelines, budgets, deliverables, and overall communications. 

 

How you’ll contribute:

 

  • Execute deliverables of all aspects of assigned clinical studies, including investigator selection, study startup and site initiation, preparation of study documentation, including protocols, consent documents, laboratory manuals, biospecimen tracking, clinical data oversight, and closeout activities.
  • Participate in preparing vendor requirements and project scope and selection of study vendors; effectively manage interactions with the vendor study team.
  • Independently manage Clinical Research Organization and other vendors, including contracts, budgets, and invoicing.
  • Provide regular updates of study progression to stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues.
  • Identify barriers to timely and successful study execution and propose solutions.
  • Provides monitoring oversight by reviewing monitoring schedules, metrics, and reports. May oversee or manage clinical documentation and reports. May be responsible for conducting on-site initiation visits and interim monitoring visits and creating applicable documentation.
  • Works on study feasibility assessments and selection of countries and sites for study conduct.
  • Assure compliance with all regulatory requirements by monitoring compliance with all company standard operating procedures (SOPs), GCP, FDA, and applicable international regulations concerning clinical activities.
  • Collaborate with data management on case report form (CRF) design, clinical trial data collection, and assist with data queries and audits to ensure data integrity.
  • Contribute to the oversight of Investigator Sponsored Trials

 

What you’ll bring: 

 

  • BA/BS degree and at least five years’ of clinical trial management industry experience (biopharma, device, or closely related field) Advanced degree preferred, additional coursework in clinical trial planning and execution
  • A strong working knowledge of clinical trial operations, clinical study design, study enrollment planning and management, and site monitoring
  • Strong experience in the management of CROs and other vendors/suppliers
  • Working knowledge of GCP, ICH guidelines, and other regulatory requirements
  • Industry experience within in vitro diagnostics (IVD) space
  • Clinical experience in oncology, ideally in diagnostics product development
  • Experience managing biospecimens and/or central and specialty laboratory vendors
  • Ability to work independently as well as part of a cross-functional team
  • Requires proven project management skills and study leadership ability
  • Excellent problem-solving ability, verbal, and written communication 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.