Senior Clinical Trial Manager H/F

il y a 3 semaines

France, FR ImCheck Therapeutics Temps plein

The Mission


The Senior Clinical Trial Manager will manage the execution of ImCheck’s clinical operations activities to support ongoing clinical trials from set-up through to reporting. The successful candidate will play a key role in maintaining and consolidating the development of ImCheck’s immunotherapeutics. The role will need to collaborate effectively across multiple teams, working with both internal and external stakeholders, to manage internal operations as well as CROs and other external vendors.


This position reports to the Director of Clinical Operations.


Key Responsibilities


  • Deliver assigned clinical program/studies as per allocated budget and timelines
  • Partnering and collaborating with cross-functional stakeholders such as Clinical Development, CMC, Regulatory, and other relevant stakeholders for successful execution of clinical trials
  • Lead and oversee the execution of phase 1 through to phase 3 trials depending on the lifecycle of the program, in compliance with ICH/GCP and local regulations, with a focus on clinical operations
  • Support the selection, oversight, and management of CROs and other vendors
  • Ensure inspection readiness and participate in related activities
  • Risk identification, mitigation, and management, including timely issue review, escalation, and management to support trend analysis and risk prevention
  • Oversee recruitment management, including thoughtful review of intelligence data, execution of recruitment strategies and mitigation planning on a global scale from country feasibility through subject recruitment and retention
  • Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other operational plan documents developed by the CROs
  • Support process improvement initiatives or serve as a subject matter expert and mentor
  • Manage and mentor Clinical Operations staff members.


The Profile


  • Degree in life sciences & industry-sponsored late-phase clinical trial experience
  • +7 years industry experience
  • End to end experience in clinical trial management (CRO selection to study close out)
  • Budget forecasting and budgeting skills for clinical trials
  • Competent in application of standard quality procedures (SOP, ICH/GCP, Global Regulations)
  • Excellent written and oral communication skills
  • Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives to actively develop strategies and drive smart decision making to support acceleration of study timelines and enable a well-run study
  • This position is based full-time in our Marseille office, with a proportion of the time working from home or traveling


Preferred Qualifications


  • Advanced degree (PharmD, PhD, master’s degree)
  • People management experience a plus
  • Experience running late phase IO clinical programs preferred
  • Experience running clinical trials in the EU, UK, and US
  • Experience in data management as it applies to clinical trials (e.g. eCRF development)
  • Ability to travel as needed (10% - 20%).


Please send your cover letter, CV and references under ref. SNRCTM02 to:


Tracey Butler – HR Director

career@imcheck.fr


ImCheck Therapeutics recognizes the importance of work-life balance and flexibility. We offer a variety of benefits, services and programs that provide our employees with the resources to pursue their professional and personal aspirations.


We are committed to creating a diverse environment and are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.


Any data processed during the recruitment process will be treated in accordance with applicable data privacy policies and regulations.

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