Clinical Project Manager H/F CDI (92)
Detail de l'annonce :
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.
Visit us on Coloplast.com.
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