Ref #: 28566

Employment type: Permanent - Full-Time

Location: United States - remote

Posted: 13-May-2021

Description

WHO WE ARE:

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:
Global Study Leader (GSL)

The 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 (ex. ICH-GCP), Standard Operating Procedures (SOPs).

Typical Accountabilities
• 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 (e.g. ACCORD, PharmaCM, etc.) 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 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
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, 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.

#pmjob

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.