Clinical Study Manager

CSM

The Clinical Study Manager is responsible to lead and manage the operational execution of one or more iTeos therapeutics clinical trials in terms of cost, timeliness and efficiency, while assuring data quality and integrity.

KEY RESPONSIBILITIES

  • Lead the development of the operational plans for clinical deliverables for assigned complex and/or multiple studies in parallel, effectively implementing design excellence in line with the Clinical Development Plan (CDP) and ensuring the principles of Good Clinical Practice (GCP). 
  • Management of study operational plan and CRO activities, including project timelines, quality of deliverables and follow-up of approved trial budget throughout the life of the clinical development. 
  • Participates in the Development of iTeos Therapeutics clinical study plans and elaborate study timelines, with particular input into operational aspects of the study and identification of cost drivers and opportunities for efficiency. 
  • Responsible for the selection and management of CROs and study-related vendors, including defining CRO or vendor responsibilities, negotiating the contract and change orders and establishing a fair and accurate budget.
  • Participates in the selection of investigational sites (feasibility), prepares recruitment projections and selection of countries and sites in collaboration with the study team and CRO. 
  • Oversees medical the development/amendment of clinical study documents, including document such as study protocols, informed consent forms (ICFs) and the preparation of the regulatory files.
  • Assist to complete the trial according to required timeframe and costs and provide assistance in execution of all programs according to clinical protocols.
  • Plans and manages Investigators’ meetings in close collaboration with the Clinical Study Physicians (CMO or Medical Directors) and other functions, including the study vendors.
  • Manages all study-related activities to meet GCP/ICH guidelines and the study protocol. Implement Clinical-related SOPs and Q&A system to meet GCP/ICH guidelines in compliance with associated regulations.
  • Oversees clinical trial sites’ adherence to pertinent regulations through review of monitoring reports, CQA-GCP audit report, communications with investigators, study site personnel, CRAs, and other CRO/designee personnel 
  • Coordination of investigational product (IP) activities, including accountability and labelling activities.
  • Participates in study data review and other review activities as assigned in accordance with GCP.
  • In collaboration with CROs, identify risks to study and develop risk mitigation plans, escalate risks and ensure rigorous risk mitigation planning.

PROFESSIONAL EXPERIENCE/QUALIFICATIONS

  • Master’s Degree in life science or related field (or equivalent experience).
  • Minimum of 3 years of clinical research experience, with minimum 1 years as a Clinical Study Manager.
  • 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 both detail, while maintaining a broad overview.
  • Experience with Phase I/II clinical trials, preferably in oncology.
  • Proven problem-solving skills.
  • Understanding of clinical operations related to clinical development functions.
  • Ability to lead multi-disciplinary, cross-functional teams both internally & externally.
  • Ability to work autonomously and in close collaboration with peers.
  • Excellent interpersonal, verbal and written communication skills. 
  • Fluent in English (oral and written communication). Knowledge of French is a plus.
  • Proficiency with computer programs including Microsoft Office suite and Microsoft Project.
  • Ability and willingness to travel 5% of the time (internationally and domestically).

 LEADERSHIP CHARACTERISTICS

  • Entrepreneurial, resourceful, energetic, self-starter.
  • Approaches challenges with creativity and pragmatism.
  • Ability to engage team to achieve goals without direct authority.

For our recruitments in Belgium, we closely collaborate with a Recruitment & Selection company, PaHRtners. Your application will be automatically forwarded to them. We, together with PaHRtners, will keep all your data confidential (GDPR compliant approach).
 

Interested ?

Send your CV together with an adapted cover letter to the following address : jobs@iteostherapeutics.com
Please mention the reference CSM in the mail object.
Your application and related information will remain strictly confidential.