Docs Global (Continental Europe)

Global Study Lead - Poland - home-based

Location
Poland
Salary
Competitive
Posted
11 Apr 2021
Closes
07 May 2021
Ref
27701
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Overview
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 (ex. ICH-GCP), Standard Operating Procedures (SOPs), policies & best practices.

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.
• 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.
• 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 Sponsor SOPs.
• 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.

Requirements:
• University degree (or equivalent educational/work experience), preferably in medical or biological sciences or discipline associated with clinical research
• 5 years clinical research experience and 3 years PM experience is needed
• Extensive knowledge of ICH-GCP, relevant regulatory/ethics requirements and clinical/drug development
• The candidates need to have at least regional PM/study management experience but global preferred as this is a lead global PM role
• Experience in all phases of a clinical study lifecycle

Why join the DOCS team at ICON?
Working at ICON is more than a job, it's a calling for people who care and are passionate about improving patients' lives. At ICON, we care about our people and your passion, you are key to our success. We aim to provide an open and friendly work environment where we empower our people and provide them with opportunities to develop their long-term career.

It takes courage to move from one job to another, the process involves careful consideration. Reach out having the conversation that would change your life and the lives of our patients. Our team of recruitment experts will provide the information you need in making the right decision.

At ICON you will have the opportunity to work with one of the global top 20 pharmaceutical companies, working on novel therapies that deliver real impact. If you want a career with a difference, ICON is the place for you.

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