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Clinical Trial Manager - IDF

Employer
NonStop Consulting
Location
Paris
Salary
Negotiable
Closing date
Nov 25, 2018

View more

Sector
Pharmaceutical, Clinical Project Manager
Contract Type
Employee
Hours
Full Time
Organization Type
Clinical Practice

Job Details

My client participates in research in prostate cancer, oesophagus cancer, urothelial cell carcinoma, kidney cancer, triple-negative breast cancer and pancreatic cancer.

The successful candidate will have the unique opportunity to work in a dynamic, highly motivated, multidisciplinary and collegial team in small private biotechnology company.

Missions:
* Planning and managing of clinical trials from planning and set-up to reporting
* Implementing and executing in a timely manner and to a high standard all aspects of clinical studies in compliance with regulations, ICH-GCP, etc. and SOPs
* Management and oversight of external contractors, such as CROs and other third party vendors to ensure adequate service provision in clinical trial execution, including evaluation, auditing, comparison of cost proposals and final selection of service providers
* Coordinating the preparation of contracts and CDAs for CROs, third party vendors and trial sites including contract negotiations
* Facilitating recruitment, tracking of timelines and milestones of clinical trials
* Coordinating the development of central clinical trial documents (e.g. clinical trial protocols, IB, ICFs), including the responsibility for the design of PIS/ICFs
* Developing supportive documents such as pharmacy manuals, lab manuals, worksheets and other documents needed for trial execution
* Contribution to preparation, organization and provision of trial materials and documents including timely provision of study-specific patient insurance documents
* Managing regulatory authority as well as ethics committee applications and approvals
* Identifying and assessing the suitability of facilities to be used as clinical trial sites
* Managing the identification and selection of investigators for the execution of clinical studies including contract negotiations with trial sites
* Filing study documentation and correspondence, responsibility for maintaining the TMF according to GCP guidelines and applicable regulations
* Managing clinical trial sites during the execution of the trial, support and participate in site visits e.g. initiation
* Responsibility for management of the trial budget
* Checking and release of invoices from sites, CROs and other service providers, preparation of accruals
* Supporting presentations and summary reports to the management
* Collaboration in definition and development of internal processes, e.g. SOP writing

Profil :
* Degree in Life Sciences or Medical Sciences
* Eight or more years of experience in clinical operations including project management, organization and documentation of clinical trials in accordance with applicable laws and guidelines (ICH-GCP, etc.), ideally in the field of oncology
* Excellent understanding of clinical operations procedures, of GCP and international regulations regarding clinical studies
* Ideally, past experience as CRA
* Profound and longstanding expertise in management of CROs and other service providers
* Experience in Clinical Data Management Software
* Excellent communication skills (both written and oral) and the ability to build effective relationships with CROs, service providers, trial centre staff and colleagues
* Fluent in English (written and spoken)


This is an opportunity to become part of a great team committed to improving quality of life for patients and to achieve your own goals in the mean time.

If you are interested in this role or if you know someone who might be in interest, please contact Benjamin MOROT on 01 76 75 33 40 or send your CV at B.Morot@nonstop-recruitment.com

NonStop Recruitment is a recruitment agency providing expert support in different niche market like pharmaceuticals, medical devices, and chemical across Europe.

Company

Our Consultants are trained to deliver an exceptional standard of recruitment services to clients across the life sciences, chemical, care, educations, technical, digital and finance industries. 

Our clients – and bottom line profits - tell us that we do a great many things very well. Complacency, however, is the last word you would associate with us. We work incredibly hard to deliver better and better results, based on stronger and stronger service delivery.  Which is why we believe the best is yet to come – for us, our clients and for the people who have what it takes to join us on the journey.

The result? We’re expanding (in the UK and across Europe and even to Boston, US) and continue to post impressive performances in all our niche sectors. 

Company info
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