Ref #: 25163

Employment type: Permanent - Full-Time

Location: North Wales, PA (Remote)

Posted: 12-Nov-2020

Description

• Perform study management tasks as per agreed delegation/oversight by Sr. GSL/GSL.
• In partnership with internal experts and external service providers, provide oversight (as delegated by the Sr. GSL/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 Sr. GSL/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.