Global Studies Leader

Description

• Lead and coordinate a cross-functional study team of experts , in compliance with ICH-GCP and Roche processes in accordance SOPs and guidelines to ensure the clinical study progresses as planned through driving the achievement of milestones according to timelines, budget and quality standards
• Provide input into and hold accountability for the development of essential study level documents (i.e. Clinical Study Protocol, Clinical Study Report) in accordance with relevant SOPs
• Develop and maintain in collaboration with CRO partners quality risk strategy, relevant study plans and data to drive clinical study execution and allow adequate oversight
• Accountable and responsible to ensure data entry timeliness and accuracy in our systems, regardless of who is accountable or responsible for entry of the data
• Lead/facilitate communication across all functions and provide guidance and support to the core and extended study team members as needed
• Drive innovation in clinical operations by thinking of and contributing to the implementation of new approaches in partnership with COE, APO and HBS in order to deliver outcomes that meet and exceed industry best practices
• Build and role model effective study partnership behaviors and mindsets with your TA aligned CRO partner to ensure we maximize the expertise of the CRO and our internal colleagues, minimizing duplication of work and ensuring cost and resource efficiency for study(ies) in responsibility
• Ensure all external service providers (ie, CROs, IXRS, ePRO, etc.) that are engaged at the study level are delivering to their contractual obligations within the agreed timelines and budget, and that oversight is documented and issues escalated as appropriate
• Oversee study level performance against agreed upon plans, milestones and key performance indicators (KPIs, quality and operational) by using company tracking systems and proactively communicating any risks to timelines and/or quality, or identified quality issues, along with proposed mitigations to your Operations Asset Leader and your People leader
• Oversee Trial Master File (TMF) completion in accordance with relevant SOPs, ensuring QC activities are performed on an ongoing basis to maintain TMF completeness at all times
• Ensure timely compliance with company-wide governance controls (e.g. Delegation of Authority, Sunshine Act)
• Develop and oversee the study budget throughout the study lifecycle including budget re-forecasting, identification of any financial risks and enactment of mitigation plans. Including proactive communication of financial risk and mitigation plans to the GOAL
• Maintain study inspection readiness at all times, according to ICH-GCP and relevant SOPs, policies/guidelines and support for asset filings; the GSL is the primary Study point-of-contact in the event of a study audit or inspection
• Provide study team members and their line managers with regular feedback on their individual performance to support their professional development and the achievement of a High Performing Organization
• Work on non-asset project work, such as the Subject Matter Experts (SME) representative in change initiatives that drive process improvements and/or lead improvement projects as discussed and agreed upon with their manager

Qualifications

• University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research
• Minimum of 7 years of relevant clinical experience in R&D in the pharmaceutical industry, including 2 years’ project management experience , or equivalent combination of education, training and experience
• Extensive knowledge of clinical research regulatory requirements and demonstrated abilities in clinical study management processes and clinical/drug development
• Demonstrated solid project management skills and knowledge of relevant tools
• Strong, demonstrated abilities/skills in team leadership
• Strong abilities in establishing and maintaining effective working relationships with internal and external co-workers and stakeholders, along with strong conflict management skills
• Excellent communication and interpersonal skills
• Strong strategic and critical thinking abilities
• Strong organizational and problem-solving skills
• Ability to manage competing priorities
• Some international and/or domestic travel may be required