Senior Clinical Research Manager in Amsterdam bei Stryker Corporation

Datum der Veröffentlichung: 10/17/2020

Stellenauszug

Stellenbeschreibung

Basic Function

Assume leadership responsibility for the preparation of clinical study protocols, budgets, case report forms, and finalization of study monitoring and data management options (either internally or through a Contract Research Organization). Ensure compliance with domestic and international regulatory requirements regarding the conduct of clinical studies (FDA, EU MDR, ISO 14155, ICH-GCP E6).

Responsibilities

  • Ensure execution of Good Clinical Practice (GCP) at all times through provision of training at start-up and initiation meetings for clinical research studies and on-going SOP development.
  • Responsible for annual clinical affairs strategic planning and budget process in the UK and Europe.
  • Execute strategy and design of clinical research studies for the UK and Europe in alignment with marketing, reimbursement, regulatory affairs, and/or research and development objectives.
  • Coordinate efficient monitoring of all studies by working with qualified staff, establishing audit procedures and ensuring that clean data are entered into database(s) in a timely fashion.
  • Ensure smooth management of the clinical research process by maintaining systems to review and track projects including all study, investigator and ethical review board information, patient recruitment activity and financial management.
  • Prepare white papers for internal use or for customer-facing promotional material to support marketing initiatives.
  • Execute publication strategy and plan in alignment with medical and marketing initiatives.
  • Collaborate with international clinical affairs colleagues to review protocols and/or clinical trial updates.
  • Review promotional and/or marketing material to support product launches and market access.
  • Review clinical evaluation reports to support technical files for CE marking.
  • Attend and/or contribute to domestic and international clinical meetings and sales meetings as needed.

Qualifications/Work Experience Preferred

  • Excellent analytical and writing skills.
  • Excellent interpersonal communication skills.
  • Effective organizational skills.
  • Hospital environment experience.
  • > 10 years previous clinical trial experience.
  • GCP certification.

Mental Requirements

  • Ability to understand and explain detailed regulations and clinical trial procedures.
  • Ability to make accurate decisions and use good judgment on complex investigations.
  • Ability to comply with complex and changing regulations and prioritize work effectively.
  • Must be able to observe and correct inconsistencies (e.g. clinical trial conduct, trend analysis, etc.)

Work From Home: Remote

Travel Percentage: 40%

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