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Job Location: Los Angeles Metro, CA
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We are seeking an experienced, high caliber Senior Clinical Research Scientist who will provide scientific expertise throughout the development and implementation of clinical evaluations, risk management and /or clinical studies. Writes/manages clinical evaluation plans or clinical trial protocols, protocol amendments, risk master lists, clinical study project timelines, clinical evaluations (plans and reports), clinical trial registrations and results postings, and scientific publications. Interacts with various study support groups and cross-functional teams in order to assist in clinical strategy, the development of plans and reports, and project deliverables. Interacts with regulatory agencies as needed, and will use their scientific and medical knowledge in order to provide directives to staff as well as study sites.
- Facilitates communication between Sales and Marketing, R&D, Clinical R&D, Regulatory Affairs, Library Services, Product Performance Group (PPG), Quality Engineering, Clinical Affairs or Clinical Science, Risk Management, Clinical Project Management, external CROs or Medical Writers, Training, Senior Management and investigational sites as directed by your manager. Conducts by conducting team meetings, drafting and sending routine correspondence (e.g., newsletters) and by presenting regular updates to senior staff;
- Creates, manages, or participates in clinical study or clinical evaluation timelines, and budgets by utilizing the appropriate project management tools, selecting providers or external medical writers, managing vendor contracts as requested, and ensuring expenditures are within budgetary guidelines
- Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process.
- Participates in the development of clinical strategy and trial design by conducting meetings with the appropriate departments and individuals to obtain feedback/direction.
- Writes clinical evaluation plans and reports, study protocols, protocol amendments, informed consents, study reports, risk master lists, and scientific papers for publication by evaluating scientific literature, analyzing scientific data and staying abreast of current clinical practice.
- Interprets results in preparation for product applications by evaluating clinical and scientific and risk data and literature, and staying abreast of current clinical practice.
- Presents scientific data by communicating accurate, succinct summaries of clinical results at industry gatherings, investigational meetings and regulatory agency meetings.
- Participates in and supports audits.
- Interfaces with management on significant matters, often requiring the coordination of activity across organizational units, physicians, and external CROs and medical writers.
- Participates in the development of other technical contributors by supporting training and providing feedback and guidance.
- May participate in a project team. Acts as a mentor to less-experienced staff and may provide work direction or supervise other technical employees.
- Exercises judgment independently.
- Plans and organizes project assignments of substantial variety and complexity. Erroneous decisions or recommendations would typically result in failure to achieve major organizational objectives
Your preferred qualifications and education:
- Bachelor's degree required. Degree in the sciences, medicine, statistics, or related discipline
- Ph.D. Degree in a relevant science preferred
- Minimum of 5 or more years of progressive clinical research
- Comprehensive knowledge of a particular technological field and is recognized as a resource in work group and across functions.
- Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
- Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
- Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
- Has broad knowledge of various technical alternatives and their potential impact on the business.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Significant body of published research in fields related to combination product development.
- Experience in medical device industry
How To Apply:
You will be directed to another website for application instructions.