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Clinical Project Manager H/F - CDI (92)

Location: 

Le Plessis-Robinson, FR

Job Family:  Marketing
Country/Region:  France

Clinical Project Manager H/F - CDI (92) 

 

This position is a member of the clinical study team supporting all study activities. His/her role is to manage clinical studies to support marketing, market access and regulatory (MDR) needs. The Clinical Project Manager is responsible for coordinating the study to make sure it runs smoothly, and all project team members are up to date on all aspect of a study and any relevant information and issues.

Responsibilities

  • Plan clinical studies (clinical investigations and/or post market clinical follow-up studies as required), recommend changes in implementation of various plans and design all project metrics and timeframe for project completion
  • Interface with service providers (Clinical Research Organization): prepare functional specifications, select subcontractors, contract and payment
  • Write, or participate in the writing of the research protocol, the information sheet, the case report forms with the help of experts
  • Creating and implementing study support documents and tools (monitoring guide, safety reporting, procedures related to clinical studies, dashboards specific to the study, etc).
  • Help in the screening of potential study sites
  • Coordinate studies with the various stakeholders (internal & external) to ensure adherence to all timeframe and maintain accuracy in process
  • Set targets for clinical monitoring staff
  • Ensure recording of trial/study/registry in compliance with project goals and study protocol.
  • Resolve protocol deviation issues
  • Analyze, synthesize, and distribute project progress reports and elements requiring decision-making. Ensure the implementation of an action plan validated by experts and/or Head of Medical Affairs
  • Ensure the preparation and organization of project meetings with the various stakeholders (including scientific, adjudication committees and so on) involved before and during the study periodically in conjunction with the Head of Medical Affairs.; write and distribute reports.
  • Perform clinical data review of data listings and summary tables, including query generation
  • Ensure publication deadlines and, possibly, collaborate with the experts and Head of Medical Affairs in the preparation of study reports, abstracts, posters, manuscripts and other type of communication.

Job qualifications

  • Bachelor’s degree with scientific background
  • At least 3 years’ experience of clinical research, preferably with medical devices and CT management
  • Knowledge of clinical research, ICH/GCP, ISO, local laws & guidelines, MDR regulations and guidelines for clinical activities
  • Experience in writing studies documentations (protocol, case report form, monitoring guide…)
  • Available to travel

Competencies

  • Autonomous, rigorous and team spirit
  • Outstanding communication skills, both verbal and written
  • Ability to demonstrate high level of organizational and planning skills
  • Flexibility and adaptability to juggle a range of different tasks and to meet deadlines
  • Able to motivate people across multiple projects
  • Ability to work independently and prioritize duties.
  • Proficient understanding of scientific methodology and statistics
  • Proficient with Microsoft software products, with the ability to develop spreadsheets, databases and reports
  • English and French language

 

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 12.000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

 

Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfil their potential and have a strong sense of belonging because – and not despite – of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability.

 

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