Clinical Project Manager

• Role: Clinical Project Manager
• Location: Paris
• Company: Neurovascular/Cardiovascular Biotech (French Born Company)
• Salary - Very competitive will discuss on application

We are looking for a Junior Clinical Project Manager to join one of our start-up Biotech clients in Paris.

Our client is a clinical stage biopharmaceutical company who focus on developing an innovative “first in-class” treatment for various emergency trials that target people who have suffered from a cardiovascular or neurovascular disease.

The company are progressing the clinical development of their pipeline and are moving one of their products into phase II/III amongst other products from pre-clinical to early phase I. This is a company that are striving towards success and have some strong plans for the next few years.

If you are a candidate who is looking for a fast-paced, highly diverse environment where you will work closely with the Senior PM team to FastTrack your development and upskill you into senior management then this could be a great opportunity for you. You will have the opportunity to work on a variety of responsibilities and these can be seen below.

Requirements:

• Early- Mid-phase drug development experience (phase I-III)
• CRO selection & management
• 2+ years in clinical project/trial management
• Life Science Degree
• Vendor oversight experience
• Deep knowledge about ICH-GCP and other relevant regulation to conduct clinical trials,
• Knowledge of IND/CTA submission to FDA and other competent authorities,
• Experience of contract and budget negotiations with CROs, vendors, consultants and sites,
• Proficient in MS Word, Excel, Power Point, Outlook, MS Project,
• Excellent verbal and written communication skills in English

Responsibilities:

• Managing and leading all aspects of clinical study projects from study planning to close-out and study report,
• Selection and oversight of performance of Clinical Research Organizations (CROs) and other vendors,
• Oversight and regular reporting of study progress to ensure successful completion within agreed timelines/ milestones and budget,
• Study site selection and performance and participation in site visits (qualification, initiation, monitoring),
• Participate in establishing, monitoring, and maintaining procedures (SOPs) to ensure program meets all GCP/ICH Guidelines and is Inspection Ready,
• Support maintaining xxx relationship with KOLs and PI’s,
• Organizing and participating internal and external meetings as required,
• Co-development and review of study documents e.g., study protocol, informed consent form, monitoring guidelines, study manuals, Case Report Forms, regulatory authority submissions,
• Routinely review of study data and progress of EDC entry; working with data management and clinical sites to resolve data discrepancies (e.g., reviewing primary and secondary efficacy and safety endpoints for inconsistency, irregularities, and/or signals),
• Working closely with and cross functional teams at xxx (e.g., with manufacturing, pre-clinical, regulatory affairs, clinical pharmacology).

Benefits 

• Bonus opportunities
• Healthcare
• Flexible working environment
• Career development opportunities alongside brands European success

Following your application Joseph Pearce, a specialist Clinical Operations Recruiter will discuss the opportunity with you in detail. 

He will be more than happy to answer any questions relating to the industry and the potential for your career growth. The conversation can progress further to discussing other opportunities, which are also available right now or will be imminently becoming available.

Please click ‘apply’ or contact Joseph Pearce for any further information

Joseph Pearce

Recruitment Consultant - Clinical Operations EU

Email: jpearce@barringtonjames.com