Global Study Director

4 weeks ago

Canada ICON Strategic Solutions Full time
  • Perform study management tasks as per agreed delegation/oversight by SrGSL/GSL
  • In partnership with internal experts and external service providers, provide oversight (as delegated by the SrGSL/GSL) to ensure study delivery of both internally-run and outsourced studies..
  • Lead/contribute to the preparation of delegated study documents (e.g. Informed Consent Form, applicable study plans, etc.), and external service provider-related documents (e.g. specifications, study specific procedures, etc.)
  • Maintain and facilitate interactions with both internal & external functions to ensure efficient study delivery to time, costs and quality objectives.
  • Manage the set-up and maintenance of third-party vendors.
  • Support the SrGSL/GSL with budget management. Initiate contract/budget requests for third-party vendors, facilitate generation of purchase orders, track spend against approved budget and manage the change order process.
  • Provide input to data management documents (e.g. Case Report Form, Data Validation Specifications), and interface with data management representatives and sites to facilitate the delivery of study data.
  • Contribute to the planning and conduct of internal and external meetings.
  • Ensure adequate supply of study materials by liaising with Clinical Supply Chain or external service providers as appropriate.
  • Proactively contribute to risk and issue identification, development of mitigation and/or action plans for identified risks and issues.
  • Ensure that all study documents within scope of the GSM’s responsibilities are complete and verified for quality in the Trial Master File (TMF).
  • Adhere to SOPs, global process, applicable Quality & Compliance manual documents and international guidelines (e.g. ICH-GCP) to ensure study is inspection ready at all times.
  • Take on assignments on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their line manager. May act as Subject Matter Expert for a particular process or system within Study Management Early.

What you will need:

University degree (or equivalent educational/work experience), preferably in medical or biological sciences or discipline associated with clinical research.

  • At least 12 months relevant pharmaceutical industry and/or clinical trial experience, in a similar role.
  • Deep understanding of ICH-GCP, relevant regulatory/ethics requirements and clinical/drug development.
  • Experience managing oncology focused CAR-T studies is a must
  • Proven organizational, time management & analytical skills; excellent attention to detail and ability to multi-task in a fast-paced and dynamic environment
  • Demonstrated ability to work well both on a cross-functional team and independently
  • Strong collaborative communication skills (verbal & written) in English
  • Ability to prioritize appropriately and to be adaptable
  • Demonstrated leadership skills
  • Computer proficiency in day-to-day tasks

Must have experience in cross-functional team management and budget oversight

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