Job Details

Pay 50-55/h depending on experience

HM’s Top Needs:

1. Clinical Evaluation experience (end to end would be ideal)

2. Experience with cardiac rhythm management devices (ideal)

3. Experience with literature management tools (ReadCube is ideal)

Education Required: 

Years’ Experience Required:

Bachelor’s degree with a minimum of 4 years of experience in clinical research/clinical evaluation/clinical evidence, or advanced degree with a minimum of 2 years of experience in clinical research/clinical evaluation/clinical evidence

This role is responsible for analyzing and integrating diverse clinical evidence to evaluate product safety and performance and identify potential data gaps or risks. The position leads and supports clinical evaluations in compliance with applicable global regulatory requirements, working closely with cross?functional stakeholders to define clinical evaluation strategies and support regulatory interactions. The role requires maintaining current knowledge of clinical evaluation best practices and the evolving clinical and regulatory landscape, and producing clear, accurate, and high?quality clinical documentation. Responsibilities also include supporting risk/benefit and state?of?the?art assessments, managing document timelines, addressing regulatory feedback, and providing guidance or mentoring to colleagues as needed.

Responsibilities may include the following and other duties may be assigned.

• Identify, compile and analyze multiple data types (clinical investigation results, literature and clinical experience, preclinical data, etc.) in order to evaluate product safety and performance and identify potential evidence gaps
• Collaborate, plan and develop clinical evaluations in accordance with relevant guidelines/regulations (i.e. CERs, clinical dossiers) with stakeholders from multiple functions and in compliance with applicable standards and in alignment with business needs
• Develop and maintain therapeutic and device operation knowledge; apply this knowledge to the development of well-written, clear and concise reports
• Identify potential evidence gaps or risks to existing data and work with stakeholders to assess options, track, and communicate risks as needed
• Develop search strategies to identify and obtain existing, relevant data (internal or external)
• Stay current on clinical evidence landscape and provide guidance to teams on sufficient data
• Develop and maintain in-depth knowledge of clinical evaluation best practices and regulatory agencies’ guidelines on clinical evaluation requirements
• Assess other technical file documents against clinical data, available current literature and industry state of the art (this may include risk management plans, IFU, etc)
• Collaborate with other functional groups (R&D, clinical, quality, marketing, etc.) to conduct risk/benefit assessments and evaluate State of the Art for the therapy area and product line
• Conduct proofreading, editing, document formatting, review comment integration and document completion / approval activities
• Address deficiencies and or answer questions from regulatory agencies as needed
• Work in close collaboration with cross-functional stakeholders to determine appropriate clinical evaluation strategy; may provide input to clinical trial design
• Interface with regulators and may lead discussions and develop strategies with cross functional stakeholders to negotiate and influence regulatory reviewers on the clinical evaluation
• Provide guidance, mentoring and coaching to colleagues
• Create and manage project schedule for each document
• May lead the development of policies, procedures, and/or process improvement initiatives for the group or clinical department