What are the responsibilities and job description for the Principal Clinical Research Specialist position at Redbock - an NES Fircroft company?
MDR- Sr. Principal Clinical Research Specialist (12 month contract // Mounds View, MN):
Top Skills Required:
- Lead the authoring and critical review scientific for Clinical Evaluation documents.
- Analyze complex clinical data into clear, accurate, and defensible written summaries
- Ensure documents are scientifically sound and consistent.
- Function as a recognized independent SME who can influence decisions
- Provide strategic clinical input to internal teams and leadership.
- Represent Clinical in cross-functional planning and help the organization understand the clinical implications of decisions.
Description: Our CER-OMA team supports our clinical-regulatory filings for all pre-market and post-market technologies across all geographies and support our global medical affairs operations with real-time scientific use-case assessments and dissemination.
Duties
- Oversees, designs, plans and develops clinical evaluation research studies
- Prepares and authors protocols and patient record form
- 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 budget
- May be responsible for clinical supply operations, site, and vendor selection
Must Haves:
- Exceptional medical writing experience, including CER and
- Preparation of CER and
- Deep clinical research and clinical evidence development experience
- Expert-level ability to write, edit, and finalize documentation
- Ability to connect scientific evidence to regulatory, commercial, and clinical ne
- Exceptional medical writing and scientific communication
Nice to Haves:
- Experience as a clinical medical writer, including experience with Clinical Study Reports (CSRs), Investigator Brochures (IBs), Risk Management Plans (RMPs), Summary of Product Characteristics (SmPCs), and Educational and promotional mater
- Foundational cardiac knowledge and experience with electrophysiology procedures/technology
Salary : $65 - $80