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Principal Clinical Evidence Specialist

CDI
Boston
Salaire : Non spécifié
Début : 04 janvier 2022
Télétravail non autorisé
Expérience : > 7 ans
Éducation : Bac +3

Tissium
Tissium

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Le poste

Descriptif du poste

We are actively recruiting for a Principal Clinical Evidence Specialist

This position requires a unique blend of medical writing experience, clinical study and medical device development knowledge, and scientific expertise. The Principal Clinical Evidence Specialist will take the clinical lead for the evidence evaluation process of TISSIUM’s products under development globally. This position is responsible for the development and execution of clinical evaluation strategies, creating summaries of safety and clinical performance, reports, and developing publication plans. A strong candidate for this position will be required to work closely with multiple product development teams, think strategically, and align activities with business objectives.

Duties & Responsibilities

  • Conduct systematic literature reviews in a documented, repeatable and traceable manner.
  • Collaborate with stakeholders from clinical, R&D, quality, marketing, etc. to conduct risk/benefit assessments and evaluate State of the Art for diverse therapies/products.
  • Work with stakeholders to plan and develop clinical evaluation strategies; may provide input to clinical study design.
  • Evaluate product safety and performance through compilation and analysis of multiple data sources (ex. pre-clinical results, clinical studies, published literature).
  • Stay current on developments on the clinical evidence landscape.
  • Produce clinical documentation including, but not limited to, clinical evaluation plans, clinical evaluation reports, and summaries of safety & clinical performance.
  • Support the cross-functional development of advertising/promotional materials.
  • Assist with interpretation of clinical study data.
  • Participate in publication and presentation development.

Profil recherché

QUALIFICATIONS & SKILLS

  • Bachelor’s degree with a minimum of 7 years in clinical research/clinical evaluations/clinical evidence, or advanced degree with a minimum of 5 years of experience in clinical research/clinical evaluations/clinical evidence.
  • Experience in technical writing of clinical evidence reports, scientific manuscripts, and summaries of safety and clinical performance.
  • Working experience with clinical and outcomes research study design, Good Clinical Practices, and FDA regulations and ICH guidelines for medical devices.
  • Basic understanding of biostatistics and clinical study design.
  • Excellent spoken and written English.
  • Knowledge of French is helpful, though not required.

COMPETENCIES & PERSONAL ATTRIBUTES

  • Autonomous and detailed
  • Dynamic and proactive
  • Ability to travel internationally
  • Disciplined and very well organized
  • Persuasive and diplomatic

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