About this opportunity:
At Freenome, we are seeking a Senior Clinical Trial Manager to help grow the Freenome Clinical Development team. The ideal candidate is independent, adaptable, a leader, delivers high quality work, and able to work cross-functionally in a dynamic environment. This person is responsible for all things related to operationalizing and executing clinical validation studies and clinical utility studies in support of IVD and LDT products in our pipeline. You are passionate about helping bring early cancer detection tests to market, and generating high quality evidence to support approvals and coverage for those products. You will have a significant impact on the continued growth of an organization dedicated to changing the entire landscape of cancer.
The role reports to the Director of Clinical Development. This role will be a Remote role with occasional in-person meetings at our headquarters, based in our Brisbane, California.
What you’ll do:
- Execute deliverables of all aspects of assigned clinical studies, including, but not limited to, investigator selection, vendor selection, study startup activities and site initiation, preparation of study documentation, including protocols, consent documents, laboratory manuals, biospecimen tracking, clinical data oversight, and closeout activities.
- Manage, lead and mentor clinical study support staff (CRAs, CTAs) as needed.
- Participate in soliciting and reviewing vendor/clinical site proposals and budgets, and subsequent selection, contracting, invoicing, and management of study vendors and/or CRO(s) as required.
- Collaborate with other clinical trial managers on the team to determine lessons learned and implement best practices across all clinical programs.
- Provide regular updates of study progress to key internal stakeholders.
- Proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues, as needed.
- Identify barriers to timely and successful study execution and propose solutions.
- Provide monitoring oversight by reviewing monitoring schedules, metrics, and reports. May oversee or manage clinical documentation and monitoring reports. May be responsible for conducting on-site initiation visits and interim monitoring visits and creating applicable documentation.
- Contribute to clinical study feasibility and timeline assessments.
- Ensure compliance with all applicable regulatory requirements by monitoring compliance with all company standard operating procedures (SOPs), FDA regulations, GCP guidance, and applicable international regulations concerning clinical activities.
- Establish and maintain effective working relationships with coworkers, managers, and clients/customers.
Must haves:
- BA/BS degree and at least six years’ of clinical trial management industry experience (biopharma, medical 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, strategies and management, and site monitoring.
- Strong experience in the management of CROs and other vendors/suppliers.
- Working knowledge of the Medical Device Regulations, CFR Parts 11, 50, 54, 56 and 812 and ICH GCP guidelines.
- Ability to work independently as well as to inspire and motivate the team.
- Proven project management skills and study leadership ability.
- Excellent problem-solving ability, verbal, and written communication skills.
Nice to haves:
- Industry experience within in vitro diagnostics (IVD) space desired.
- Clinical experience in oncology, ideally in diagnostics product development.
Benefits and additional information:
The US target range of our base salary for new hires is $157,675 - $221,550. You will also be eligible to receive equity, cash bonuses, and a full range of medical, financial, and other benefits depending on the position offered. Please note that individual total compensation for this position will be determined at the Company’s sole discretion and may vary based on several factors, including but not limited to, location, skill level, years and depth of relevant experience, and education. We invite you to check out our career page @ freenome.com/job-openings/ 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.
Applicants have rights under Federal Employment Laws.
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