Ref #: 26082

Employment type: Permanent - Full-Time

Location: Canada - Ontario - Toronto

Posted: 15-Mar-2021

Description

JOB SUMMARY:


The Global Study Lead (GSL) is accountable for delivery of global clinical studies to agreed timelines, budget and quality standards from study set-up through maintenance, close-out and study archiving. The GSL leads and/or maintains oversight over a cross-functional team comprised of internal and external partners to deliver the clinical study effectively and in accordance with applicable clinical trial regulations and Standard Operating Procedures (SOPs).

PRIMARY RESPONSIBILITIES:

Lead, provide guidance and delegate appropriately to a cross-functional study team or oversee outsourced delivery activities to ensure the clinical study progresses as planned, driving achievement of milestones according to timelines, budget and quality standards. May hold accountability and/or oversight of several studies.

• Lead and facilitate communication across all functions. Lead and conduct investigator meetings and other study related meetings.
• Provide input into and hold accountability for the development of essential study documents in accordance with relevant SOPs.
• Ensure all external service providers engaged at the study level are performing to contracted goals and timelines/budget. Ensure
adequate oversight is documented and any issues are escalated appropriately. May participate in vendor selection activities.
• Develop and maintain relevant study plans as well as detailed and realistic study timelines.
• Accountable for ensuring that all systems utilized at a study-level are maintained.
• Accountable for leading the identification of overall study-level risk management activities. Ensure mitigation strategies are
implemented effectively and that issue escalation pathways are clear to the entire study team.
• Oversee study level performance against agreed upon plans, milestones and key performance indicators. Communicate key risks and
proposed mitigations to applicable stakeholders.
• Maintain oversight over quality issue reporting in accordance with relevant AZ SOPs and collaborate with all functions and/or external
service providers as necessary to implement corrective and preventative actions.
• Oversee Trial Master File (TMF) completion from study start until archiving, in accordance with relevant AZ SOPs.
• Ensure timely compliance with company-wide governance controls (e.g. Delegation of Authority, Clinical
Trial Transparency, etc.).
• Accountable for study budget management (and re-forecasting where required) through the study lifecycle. Provide budget progress
reports and highlight financial risks and mitigation plans.
• Maintain oversight of study inspection-readiness, in accordance with ICH-GCP, AZ SOPs and relevant policies/guidelines. Act as the
functional lead in the event of an audit or inspection.
• Oversee individual performance of study team members and ensure resource is utilized efficiently.
Identify and communicate resource gaps for assigned studies. May mentor less experienced colleagues.
• Work on non-drug project work such as process improvements 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.



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.

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