Santa Clara, CA
Our client is looking for an experienced Clinical Scientist for a 24-month project in Santa Clara, California. The Clinical Scientist must have extensive experience performing a wide spectrum of bench or instrument procedures. The ideal candidate would provide medical device clinical evaluation knowledge, scientific and medical expertise, analytical thinking abilities, and medical/technical writing skills throughout product lifecycle management. If you are an experienced Clinical Scientist, this position could be the next great step in your career.
- Responsible for compliance with applicable corporate and divisional policies and procedures, applicable regulations, upcoming medical device regulations (MDR) and other applicable EU and FDA guidance documents or regulations
- Obtain and analyze current Instructions for Use (IFU) along with certificates
- Work with librarian to develop a literature search strategy and protocol
- Obtain product complaint data and analyze the data
- Incorporate results into the clinical evaluation report (CER)
- Actively participate, reviews and give input into development of post-marketing surveillance (PMS) plan and post-marketing clinical follow-up (PMCF) plans
- Actively participate, reviews, and give input into developing or updating risk assessments
- Oversee clinical safety and risk analysis review
- Obtain investigator-sponsored study (ISS) information and include in the CER as applicable
- Develops and maintains Clinical Evaluation DOP and associated documentation
- Provides input to cross-departmental SOPs and DOPs describing risk information processes
- Work cross-functionally with the Risk Master List (RML) product team and help identify appropriate sources of relevant data
- Interpret, evaluate and incorporates information from various sources including literature, clinical data, and medical references into the CER
- A minimum of five years of experience in clinical research, risk surveillance and management, clinical evaluation reports, or regulatory affairs (medical devices or equivalent in pharmaceuticals)
- Good literature appraisal, evaluation, and weighting skills, ability to critically evaluate medical data
- Able to independently write routine technical documents, and perform independent analyses
- Must have solid clinical understanding of disease state and the implications of treatment as it relates to patient
- MD, PhD, PharmD in biomedical field
To be a best-fit your strengths must include
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
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