Ref #: 28948

Employment type: Permanent - Full-Time

Location: Canada - ON - Mississauga

Posted: 13-May-2021



At DOCS, we care about our people and their passion, as they are the key to our success and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term career. We have over 4500 employees globally working on novel therapies that deliver real impact to patients in need.

All our team members have the independence to get the job done and support from the experienced leadership team when you need it. If you want a career with a difference, DOCS is the place for you.

Job Description:
The GSA supports delivery of global clinical studies from study set-up through maintenance, close-out and study archiving. The GSA supports the Senior Global Study Leader (SrGSL), Global Study
Leader (GSL) and/or Global Study Manager (GSM) with coordinating activities, ensuring quality and consistency. The GSA supports with administration & systems and with other delegated aspects of clinical study execution in accordance with applicable clinical trial regulations (ex. ICH-GCP), Standard Operating Procedures (SOPs), policies & best practices and values &

Job Accountabilities:
Support the SrGSL, GSL and/or GSM by completing delegated study work as required. May work across many different studies and delivery models concurrently.
• Set-up, maintain and close of the Trial Master File (TMF)as delegated by the GSL/SrGSL. Ensure compliance to ICH-GCP and SOPs.
• Interact/collaborate with internal and external stakeholders in collection of regulatory and other essential documents/information.
• Oversee the collection, review and track relevant study documents in TMF.
• Support production of study documents (as delegated), ensuring template and version compliance per study-specific requirements.
• Contribute to and distribute meeting material and other varied forms of communication.
• Contribute to electronic applications/submissions in ANGEL by creating and managing clinical- regulatory documents according to the requested technical standards and supporting effective publishing and delivery to regulatory authorities. Collate the administrative appendices for the Clinical Study Report.
• Set-up, populate and accurately maintain information in tracking and communication tools
(e.g. CTMS, SharePoint, MS Teams etc.) and support team members in the usage of these tools.
• Support the SrGSL/GSL with tracking, reconciliation and follow-up of the study budget/payments in relevant systems (e.g. iBUY).
• Maintain internal & external contact lists to facilitate communications among updated personnel.
Manage access to various study systems (e.g. EDC, CTMS, SharePoint, IxRS, MS Teams etc.).
• Manage and contribute to the coordination, supply and tracking of study materials and equipment.
• Coordinate administrative tasks and logistic support throughout the conduct of the study, audits and regulatory inspections, according to policies and SOPs. Support inspection readiness activities as required throughout the course of the study.
• Lead the practical arrangements and contribute to the preparation of internal and external meetings.
• Work on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their

DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.

DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment