Docs Global (Continental Europe)

Global STudy Leader/ office-based/ Warsaw

6 days left

Warsaw, Poland
03 Feb 2021
05 Mar 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)
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), policies & best practices and AZ values & behaviours.

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 Sponsor 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 Sponsor 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.

Education, Qualifications, Skills and Experience
• University degree (or equivalent educational/work experience), preferably in medical or biological sciences or discipline associated with clinical research
• Minimum of 5 years progressive experience in phase clinical research, with at least 3 years of clinical development project management experience (or equivalent) at least on the regional level.
• Extensive knowledge of ICH-GCP, relevant regulatory/ethics requirements and clinical/drug development
• Thorough understanding of cross-functional clinical processes including data management, biostatistics, medical writing, drug safety, and regulatory affairs
• Demonstrated abilities in clinical study management processes and clinical/drug development
• Extensive and proven experience in driving operational delivery to timelines, cost and quality
• Strong strategic and critical thinking abilities
• Ability to manage complex situations. Proven complex problem solving and decision-making skills.
• Excellent attention to detail and ability to multitask in a fast-paced and dynamic environment.
• Experience and strength in leading and managing cross-functional study teams
• Strong abilities in establishing and maintaining effective working relationships with internal and external stakeholders, along with strong conflict management skills
• Proven experience leading delivery through internal and external organizations
• Experience in external provider oversight and management
• Excellent collaborative communication skills (verbal & written) in English and strong interpersonal skills
• Computer proficiency in day-to-day tasks
• Advanced degree, Masters level education(or higher)
• Project management certification
• Proven project management experience on a global level
• Experience in all phases of a clinical study lifecycle