Global Study Director

2 weeks ago

Toronto, 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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    Toronto, Canada ICON Strategic Solutions Full time

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