REVA Medical is an innovative medical device company devoted to developing and manufacturing novel polymer devices for the treatment of vascular disease that improve health and quality of life. We currently have an immediate opening for a Preclinical Project Manager.

Summary of Essential Duties and Responsibilities:
Serve as study director for preclinical stent studies. Manage concurrently a variety of contracted in vivo studies, primarily coronary stent/catheter studies, from initiation to study end with final reports. Travel to preclinical studies to manage study as required.

Prepare study design, protocol, budget, purchase orders (POs); obtain study and budget approvals; establish study supply needs and ensure shipment to study sites; coordinate outside technical and veterinarian care support as needed.

Schedule studies with Test Facilities and subcontractors. Manage and track handling and processing of each Subcontractor’s deliverable (specimens, images, data), ensure timely work completion; catalog all items received.

Maintain documentation and records in accordance with references and standards. For example, update implant tracker, deployment records, complications record, necropsy records, sample disposition, IVUS, QCA and OCT records. Perform QC of data entered into records.

Provide reports capturing the status of each study’s in-life, subcontract activities and all associated reports and deliverables. Highlight critical study dates, deadlines, travel schedules; and, facilitate data analysis and awareness, completion of reports and study closures.

Review image data (Faxitron, IVUS, QCA and OCT) and prepare summaries and reports as needed.

Prepare overall study reports as needed and documents for scientific review, regulatory submissions, investigator brochures and other company publications.

Develop and manage budgets and costs for porcine preclinical studies. Perform reconciliation of invoices to POs, provide documentation of invoices relative to budget and POs.

Locate, evaluate (audit) and contract professionally managed labs in support of the company’s preclinical program; obtain all necessary approvals (IACUC) and ensure vendors are approved through Company’s approved supplier procedure.

Participate in multi-disciplinary project team to support product development.

Perform other duties as assigned.

Education and/or Experience:
Previous experience (minimum 8 years at other business or 3-5 at this company) conducting preclinical studies required in the medical device industry. Experience in vascular/cardiovascular stent/catheter studies preferred. Degree in physiology, biological sciences or related technical field preferred. Experience in preclinical or clinical interventional cardiology/radiology is a plus.
Demonstrated ability of managing multiple projects concurrently. Strong organizational, communication and interpersonal skills are essential.
Well versed in Microsoft Word, Excel, and PowerPoint.

Required Knowledge/Skills:
Must be able to travel
Proven record of preclinical medical products research and broad understanding of various preclinical research methods and GLP procedures. Ability to learn new concepts/processes, and improve current processes.
Ability to work successfully in a cross-functional team environment and with subcontractors. Must be highly motivated, flexible and a strong team player who is proactive and resourceful.
Candidate should be career focused on preclinical studies.

If you meet the above qualifications, please submit your resume along with salary expectations for immediate consideration. REVA Medical offers a competitive salary and benefits package.

• Location: San Diego, CA
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