Description: Full Time, Exempt
Department: Clinical Affairs
Reports to: SVP, Strategy, Development and Operations
Location: San Diego, CA
Job Description No.: 622-2-24
Biomatrica’s mission is to contribute to the development of better diagnostics and therapies, with improved access for patients globally. Based in San Diego, Biomatrica is privately held. The company is founded on a compound library and intellectual property which it deploys to collect, protect and store biomaterials subject to degradation, including nucleic acids, proteins, and cells. The applications are broad and include diagnostics, biobanking, research, and industrial. The company recently introduced an innovative line of CE-IVD marked sample collection products for: (1) cell-free DNA and tumor cells in blood for pre-natal testing and liquid biopsy, (2) DNA in saliva for medical and personal genomics, (3) RNA and DNA for gene expression testing.
The Clinical Study Manager is responsible for all aspects of management of clinical studies at Biomatrica. This individual participates in the development of clinical study strategy, and manages operational and logistical tasks of clinical studies to ensure their efficient execution within established budgets and timelines, ensuring all activities occur in compliance with the appropriate regulations, including FDA regulations, GCP, IDE, 510 (k) guidelines etc. To achieve these goals, the Clinical Study Manager works with members of each project team, as well as subject matter
experts (SMEs) in areas such as Product Development, Regulatory and Marketing. The Clinical Study Manager is the point of contact for all external resources, including Principal Investigators, clinical laboratories, external service providers, contract research organization, Institutional Review Boards, etc.
Essential Duties and Responsibilities
- Participate in setting strategic direction and hands-on leading clinical trials and multicenter studies.
- Participate in defining clinical applications of Biomatrica’s products and contribute in the development of post-market clinical studies using Biomatrica’s products, initiated by domestic and international clinicians.
- Manage and/or coordinate all aspects of clinical research trials, including planning, study designs, site selection, contracts with study sites and Principal Investigators, IRB approvals, subject recruitment, site training, study execution and oversight/auditing, data collection, documentation, site close-out and generation of study reports.
- Ensure that study designs and outcomes support regulatory submissions (PMA, IDE, 510(k)), as well as goals of post-market clinical studies and clinical pharmaco-economic evaluations.
- May co-author and/or work with KOLs and others to develop publications based on the results of the clinical studies and trials.
- Provide updates and status reports to senior management on a regular basis; report on performance against plan.
- Develop and manage the budgets for clinical studies. Ensure overall operation is within the approved budget and timeline.
- Develop and implement SOPs for clinical studies and related activities.
- Ensure Biomatrica’s compliance with all applicable regulatory standards related to global clinical studies and trials and interactions with physicians.
- Interface with departments within and outside of Biomatrica. including Product Development, Manufacturing, Regulatory Affairs, Marketing and Sales.
- Coordinate and/or manage internal staff and outside partners/service providers.
- Serve as the central point of contact between and among internal and external resources participating in clinical studies.
- B.S. or Master’s degree in related field required; a Ph.D. is a plus.
- 4-6 years of experience in IVD product or biotech/pharma development with evidence of hands-on managerial experience running clinical trials and managing teams.
- Experience with all aspects of management of clinical trials from inception to completion.
- Strong knowledge of FDA QSR requirements relating to IVD clinical practices.
- Previous experience in preparing study protocols, IRB submissions, CRFs and site contracts.
- Previous clinical trial site management experience (set-up, training, auditing, close-out).
- Knowledge of and experience in establishing clinical study designs.
- Basic understanding of statistics and statistical methods.
- Knowledge of Good Clinical Practice (CGP).
- Strong project planning, leadership, negotiation, and presentation skills as well as an ability to contribute creative yet practical solutions to problems.
- Extraordinary researching skills and expertise in searching medical literature and databases for clinical and technical information.
- Ability to multi-task and manage several projects in parallel, paying attention to detail.
- Ability to forge cross-functional working relationships with internal teams and external project partners.
- Ability to be proactive in identifying issues and hurdles that may handicap the effective implementation of the trial and resolve the issues in a timely fashion.
- Superior writing skills and ability to effectively communicate with technical and non- technical people.
- Ability to work in a team environment.
- Ability to travel as required (10-40%).
If you are looking for a position with growth potential in an exciting industry, please forward your resume with a cover letter to: email@example.com and note “Clinical Study Manager” in the subject line of your e-mail. Please send attachments in MS Word or PDF format only with “your name-resume” and “your name-cover letter” as the document name. Relocation reimbursement is not available for this position.
Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons.