Logo 88JOBS

CLINICAL OPERATIONS MANAGER

Paris, France

50-75K

Autre secteur CDI Plein temps

Niveau de langue

Français - Bilingue Oral, Ecrit

Description

88BIOSCIENCE is a new recruitment brand specialized in Lifescience and Biotech from 88JOBS, the multi-specialist recruitment platform based in Europe and Asia. Our mission is to provide a professional, friendly and overall, reliable service for those looking for work and companies looking for staff.

 

Today, 88BIOSCIENCE is looking for a Clinical Operations Manager to join a Biotech in Paris.

 

The hiring company: Our client is a pharma company specialized in the research and development of treatments for cancer and neurodegenerative diseases. More than 10 research projects in more than 30 countries are currently being conducted by this company.



The job responsibilities:  

  • Identify and select our Contract Research Organization (CRO) partners globally and manage the qualification process to completion with all internal stakeholders and appropriate documentation.
  • Ensure master service agreements, task orders and letters of delegation are current and signed.
  • Validate the experience of all supervisory personnel prior to commencement of work.
  • Follow up on induction training with the archiving of supporting documentation on GCP experience and training.
  • Ensure training of CRO monitors and managers on SOPs applicable to clinical operations and prepare or adapt tools or support documents to assist CRO monitors (example: CRO set-up guidelines).
  • Track the performance of our CRO partners (study parameters; monitoring parameters; assigned personnel; completion).
  • CRO CAPA Audit.
  • Ensure regular communication with CRO management to review performance, quality, and staffing.
  • Develop regular global communication with instructors and RCO leadership to share reminders, lessons learned, new SOPs, etc.
  • Follow up on quality control and regulatory compliance, GCP and SOPs of CRO partners by conducting accompanied site visits.
  • Ensure CRO partners are fulfilling all assigned responsibilities in accordance with MSAs and work orders.
  • Support clinical project leaders when monitoring issues or requests for monitoring support are escalated.
  • Work closely with all clinical departments.
  • Finalize with the Quality Assurance department the CAPA plan for CRO audits and ensure that they are conducted within the agreed upon time frame.
  • Ensure inspection/audit readiness.



Profil recherché

You are the person the hiring company is looking for if you have:
  • You have a Master of Science degree
  • You have a minimum of 5 years experience in clinical monitoring
  • You are familiar with national and international regulations on clinical research (ICH-GCP, 21 CFR, Declaration of Helsinki).
  • You are fluent in French and English
  • Experience in a CRO is a plus


The next steps after submitting your application:


- A 88BIOSCIENCE consultant will analyse your application and contact you
- The consultant will then forward your application to the recruiting company
You will have a first telephone interview with the company's HRD
You will have a second face to face interview with the Deputy CEO of the company
- You will receive a job offer


Autres informations

Start date: as soon as possible
Type of contract: Permanent
Job type: full time Salary : 50-75k € per year

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