Ref #: 25945

Employment type: Permanent - Full-Time

Location: UK - Home-Based

Posted: 18-Feb-2021


Basic requirements for the Global Study Leader (Oncology or BioPharma) role;
• For this role, we need you to have at least regional PM experience though global project management experience preferred as this is a lead global PM role
• You will need to understand the cultural difference between pharma and CRO
• Need to demonstrate an understanding of the global PM role
• 5 years clinical research experience and 3 years PM experience needed, along with the right-to-work in the UK.

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 AZ 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 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.

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 early phase clinical research, with at least 3 years of clinical development project management experience (or equivalent)
• 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 multi-task 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