Job Summary
We are seeking a Principal Clinical Research Specialist to provide scientific leadership and clinical expertise in support of innovative medical device products. In this role, you will lead the development of Clinical Evaluation Reports (CERs), analyze complex clinical data, and serve as a key clinical subject matter expert influencing cross-functional and strategic decisions.
Key Responsibilities:
- Lead the authoring, review, and approval of Clinical Evaluation Reports (CERs) and other scientific documentation.
- Analyze complex clinical data and translate findings into clear, accurate, and scientifically defensible reports.
- Provide strategic clinical input to cross-functional teams, leadership, and product development initiatives.
- Ensure clinical documentation meets regulatory requirements and is scientifically sound.
- Support the planning, oversight, and interpretation of clinical research studies in accordance with GCP, SOPs, and regulatory standards.
Qualifications:
- Extensive experience in clinical research within the medical device industry.
- Expert-level medical writing and scientific communication skills.
- Strong experience developing Clinical Evaluation Reports (CERs) and clinical evidence strategies.
- Ability to connect scientific evidence with regulatory, clinical, and commercial objectives.
- Experience with cardiovascular devices, particularly electrophysiology (EP) procedures and technologies, is highly preferred.
- Proven ability to serve as a clinical subject matter expert and influence strategic decision-making.
This is an excellent opportunity for a senior clinical professional to make a significant impact on the development and commercialization of cutting-edge medical technologies.
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Job Disclaimer:
Equal Opportunity Employer/Veterans/Disabled
Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client
To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/
The Company will consider qualified applicants with arrest and conviction records.
Pay: $60.00 - $72.00 per hour
Benefits:
- Dental insurance
- Health insurance
Work Location: In person
