Sr. Principal Clinical Research Specialist

Job Description

Job Summary:

• 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.
• 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.

Duties and Responsibilities:

• Lead the authoring and critical review scientific and 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.

Differentiating Factors:

Autonomy:

• Recognized master’s in professional discipline.
• Works independently to implement strategic goals and establish operational plans for job area.
• Assignments are often self-initiated Determines and pursues courses of action necessary to obtain desired results.

Organizational Impact:

• Strongly influences the design of new products, processes, standards, or operational plans based on business strategy with a significant impact on functional results.
• Implements strategic goals established by functional leadership.
• Changes or may establish operational plans for job area with long-range impact on results.

Innovation and Complexity:

• Faces problems that span a wide range of difficulty and unique issues across functions and / or businesses which may cause redirection.
• Develops solutions to unique issues Improves upon existing processes and systems using significant conceptualizing, reasoning and interpretation.

Communication and Influence:

• Interacts with internal and external customers and vendors at various levels, including executive leadership, on significant matters.
• Conducts briefings with senior leaders within the job function.
• Negotiates with others to reach understanding or agreement.
• Leadership and Talent Management: Frequently provides guidance, coaching and training to other employees.
• Typically manages large, moderately complex initiatives of strategic importance to the organization, involving large cross functional teams.

Must haves:Exceptional medical writing experience
CER (Clinical Evaluation Report)
Performance Evaluation Report (PER)
Deep clinical research and clinical evidence development experience
Expert-level ability to write, edit, and finalize document
Ability to connect scientific evidence to regulatory, commercial, and clinical needs
Exceptional medical writing and scientific communication
Nice to haves:Foundational cardiac knowledge and experience with electrophysiology procedures/technology
Clinical medical writer
Ad-hoc CER Medical Writer

Required Knowledge and Experience:

• Requires mastery level knowledge of specialty area and working knowledge of several other areas, typically obtained through advanced education combined with experience.
• May have deep knowledge of project management.
• Requires a University Degree and minimum of 10 years of relevant experience, or advanced degree with a minimum of 8 years of relevant experience.