Offre d'emploi : Clinical Trial Manager (M/F)
iTeos Therapeutics is a publicly held (NASDAQ: ITOS), clinical-stage biopharmaceutical company dedicated to extending and improving the lives of cancer patients by designing and developing next generation immunotherapies.
Based in Gosselies, Belgium and Cambridge, MA, iTeos Therapeutics was founded out of the Ludwig Institute for Cancer Research (LICR) and the de Duve Institute (UCLouvain) in 2011. In March 2020, the Company completed a $125 million Series B2 financing, and in July 2020, we completed our IPO raising over $200million of proceeds.
This additional capital will allow iTeos Therapeutics to continue to develop its clinical pipeline and maintain its investments in the discovery research team to leverage its fantastic science to improve the lives of cancer patients. For more information, please visit www.iteostherapeutics.com
iTeos Therapeutics is now considered as a world-class actor in the sector. To carry on its growth and reinforce its team, iTeos Therapeutics is looking for a (f/m): Clinical Trial Manager
Reporting to the Clinical Operations Manager, you play a significant role in the management of clinical studies and in the development of new treatments. You will provide leadership and ensure that clinical studies are completed within budgets, on time and with the highest quality.
Your main responsibilities are :
- Participate in the development of clinical study plans and elaborate study timelines.
- Responsible for leading and managing the operational execution of clinical studies in terms of cost, timeliness and efficiency.
- Responsible for the selection and management of CROs and study-related vendors.
- Participate in the selection of investigational sites.
- Oversee the development or amendment of clinical study documents.
- Manage all study-related activities to meet GCP/ICH guidelines and the study protocol.
- Ensure appropriate filing of study documents in the trial master file
- Oversee clinical trial sites’ adherence to pertinent regulations.
- Coordinate investigational product activities, including accountability and labelling activities.
- Participate in study data review and other review activities as assigned.
- In collaboration with CROs, identify risks to study and develop risk mitigation plans, escalate risks and ensure rigorous risk mitigation planning.
- Master’s Degree in life science or related field (or equivalent experience).
- Minimum of 3 years’ experience in the clinical field.
- Solid vendor management skills including previous experience negotiating vendor/site contracts and managing the budgets.
- Thorough understanding of FDA, EMA, ICH and GCP guidelines.
- Possess strong analytical skills and highly organized project management abilities, keeping an eye on detail, while maintaining a broad overview.
- Experience with Phase I/II clinical trials, preferably in oncology.
- Excellent interpersonal, verbal and written communication skills.
- Fluent in English (oral and written communication). Knowledge of French is a plus.
- Ability and willingness to travel 5% of the time (internationally and domestically).
- An exciting opportunity to contribute in a meaningful way to the development of innovative IO drugs for cancer patients.
- The opportunity to work in a science-driven, dynamic and high-potential innovative biotech company.
- A challenging scientific and business growth in which you get to bring your knowledge and skills.
- An employment agreement contract with an attractive salary package in line with the position responsibilities and your experience.
Please send your CV together with an adapted cover letter via https://www.pahrtners.be/fr/offres-demploi/clinical-trial-manager/ or to email@example.com
Your application and related information will remain strictly confidential.
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