MDR - Prin Clinical Research Spec
8200 Coral Sea Street Northeast Saint Paul, MN 55112 US
Pay 50-65/h depending on experience
The successful candidate will have a previous work history in the medical device or pharmaceutical industry with focus on clinical research, clinical studies, and/or FDA filings.
A history in cardiovascular research or CV medicine will be helpful, and a work history of medical writing is critical.
Previous work history in writing Clinical Evaluation Reports (CERs), Medical Device Regulations (EU MDRs) reports, and/or FDA filings is critical for a successful candidate.
Familiarity with electrophysiology and/or cardiac arrhythmias is a plus.
HM Top 3:
- Previous work history with CERs and EU MDRs
- Previous work history in medical device or pharmaceutical research (i.e., no academia or research scientist candidate).
- Previous work history in the cardiovascular space.
- Preferred PhD or MD
- Minimum is BS + proven work history
Years’ Experience Required:
- +5 years of medical writing or work in industry
Responsibilities may include the following and other duties may be assigned. Oversees designs plans and develops clinical evaluation research studies. Prepares and authors protocols and patient record forms. Conducts registered and nonregistered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential. Oversees and interpret results of clinical investigations in preparation for new drug device or consumer application. Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures SOP good clinical practice GCP and specific country regulations and may prepare clinical trial budgets. May be responsible for clinical supply operations site and vendor selection.
SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies using specialized knowledge and skills normally acquired through advanced education typically University.
Autonomy: Recognized expert managing large projects or processes . Exercises considerable latitude in determining deliverables of assignments with limited oversight from manager . Coaches reviews and delegates work to lower level specialists.
Organizational Impact: Contributes to defining the direction for new products processes standards or operational plans based on business strategy with a significant impact on work group results . May manage large projects or processes that span outside of immediate job area.
Innovation and Complexity: Problems and issues faced are difficult moderately complex and undefined and require detailed information gathering analysis and investigation . Develops solutions to moderately complex problems and/or makes moderate to significant improvements of processes systems or products independently to enhance performance of job area. Implements solutions to problems.
Communication and Influence: Represents organization as a primary contact for specific projects and initiatives communicates with internal and external customers and vendors at various levels . May negotiate with others to reach understanding or agreement and influence decisionmaking.
Leadership and Talent Management: Typically provides guidance coaching and training to other employees within job area. Typically manages major / moderately complex projects involving delegation of work and review of work products at times acting as a team leader.
Required Knowledge and Experience: Requires mastery of a specialty area and full knowledge of industry practices typically obtained through advanced education combined with experience. May have broad knowledge of project management. Requires a University Degree and minimum 7 years of relevant experience or advanced degree with a minimum of 5 years of relevant experience.
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