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Clinical Project Manager
Closing Date: 01 Nov 18
Salary (£): On Application
Benefits: Excellent and Comprehensive Benefits – see below
Description : Clinical Project Manager (f/m) : Munich, Germany TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a Clinical Project Manager (f/m) to strengthen the team of one of our TOP Pharmaceutical client Companies in NRW, Germany. Main Job Tasks and Responsibilities · Define and author clinical investigation documents (e.g.
Job Title: Clinical Project Manager (f/m)
Location: Munich, Germany
TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a Clinical Project Manager (f/m) to strengthen the team of one of our TOP Pharmaceutical client Companies in NRW, Germany.
Main Job Tasks and Responsibilities
· Define and author clinical investigation documents (e.g. CIP, CRF, informed consent, patient infor¬mation) as required by ISO 14155, ICH-GCP and applicable standards. Ensure proper review and quality control of clinical investigation documents.
· Define, author and be responsible for submission of clinical investigations to the required ethic committee/review boards and competent authorities, as applicable. Coordinate with the department of regulatory affairs especially for investigations with products which do not have market approval.
· Manage external providers within assigned clinical investigations; drive the selection process.
· Ensure study specific training for participating parties (e.g. CRAs, investigators, site personnel) as far as necessary to ensure adequate quality of the assigned clinical investigations.
· Maintain regular visit and/or telephone contacts with study investigators and other study specific interfaces.
· Supervise the monitoring for assigned clinical studies according to ISO 14155 / CFR FDA and ICH-GCP standards in collaboration with the monitoring representatives and/or external providers. Perform monitoring or co-monitoring visits as applicable.
· Supervise the completion, source verification, collection and review of data in clinical investigations.
· Hold close contact with the data manager and/or statistician and support him/her in the set-up and maintenance of the study data base, coordinate and complete study specific requirements.
· Assure proper handling and reporting of all safety and clinical events according to regulatory and study specific requirements for all devices being tested in clinical investigations. Hold close contact with the safety reporting team.
· Plan and control the budget for assigned clinical investigation.
· Report/communicate relevant details and milestones concerning the clinical studies to the Director, Clinical Affairs or upper Management. Enable adequate management actions where necessary.
· Organize the archiving of clinical investigation documents within his/her responsibilities.
· Be prepared for internal or external ISO 14155/ CRF FDA/ICH-GCP audits within assigned clinical investigations.
· Review regularly relevant literature and other sources for information supporting his/her ongoing and future projects and to support information management systems, as available.
· Be up to date with all current trends in the Clinical Affairs field by regularly screening the relevant literature, guidance and regulatory documents, attending congresses or scientific meetings, and attend trainings, as applicable.
· Support the Director CA in representing the Clinical Affairs department within the company and outside.
Education and Experience
· Thorough, conscientious and results oriented working style. Computer skills in word processing, presentation and calculation software. Strong communication and organization skills, team spirit, good written and spoken German or French and English language skills.
· University degree or equivalent in scientific or medical field required with at least 2 year experience in clinical project management in Clinical Research Department in Medical Devices / Pharmaceutical companies / CRO.
· Alternatively good medical background (e.g. nurse, cath-lab technician) with at least three years of CRA experience; or comparable experience in clinical research.
· Ideally 5-7 years minimum experience.
· Basic knowledge of European and international regulations of Good Clinical Practice (GCP) and ISO 14155, experience with Class II & III medical devices preferred, documented basic continuing education in clinical research or experience in clinical research
If you have the experience needed for this position, please contact Alexander Sourounis, Senior Consultant TalentSource Life Sciences Unit, and send your CV in WORD format to firstname.lastname@example.org or apply through https://www.talentsourcelifesciences.com/find-a-job/
Why TalentSource Life Sciences/Cromsource
CROMSOURCE is a family-owned, high quality ISO-certified international provider of outsourced services to the pharmaceutical, biotechnology and medical device industries. Since 1994, we have been supporting our clients with outstanding clinical research and staffing solutions services. TalentSource Life Sciences is a fully dedicated flexible resourcing unit within CROMSOURCE and the successful growth has been achieved by putting high quality and client focus at the heart of everything we do.
Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.
Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are providing expert people. Highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world. Our large management team consists of a people with an extended experience within pharma and a high level of market knowledge. We our open, friendly and approachable and aim to support you through the recruitment process every step of the way.
As this position is client-facing, the successful candidates must be confident and be able to drive the role and themselves and to work autonomously in close liaison with a line manager at TalentSource, who will provide you with mentoring and guidance.
To ensure the success of our clients, our team of international professionals is focused on continuous improvement. We invest in our employees by providing the coaching and training necessary to deliver high quality services for our clients.
Every day we strive to create an environment in which all employees can contribute to their full potential and at the same time allow the company to develop and grow with them. With CROMSOURCE you will be able to participate in exciting projects and achieve your professional goals.Clinical Project Manager
CROMSOURCE Suite 3 Lomond Court Castle Business Park Stirling United Kingdom
|Tel:||+44 (0) 1786 468990|
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