Global Study Lead

Roche • Tucson, AZ

5d • $112,700 - $209,300

About The Position

The Global Study Lead is responsible for ensuring sponsored studies are appropriately designed, planned, executed, monitored, closed out, and documented within planned timelines and costs. The role fulfills sponsor responsibilities while ensuring compliance with applicable regulatory requirements, and is accountable for study timeline and budget planning and execution. The Global Study Lead assigns and ensures delivery of tasks by study-team members and oversees external support, including CROs, consultants, and medical advisors.

The role leads the global study team and is fully accountable for study deliverables in terms of quality, budget, and timelines. In collaboration with study teams, internal and external experts, and Program Leadership, the Global Study Lead develops high-quality study designs and evidence-generation scenarios that support global strategies. The position develops key study documents, oversees operational planning for companion diagnostics studies sponsored by Pharma partners, and manages sponsored studies for registrational and non-registrational purposes across all study phases.

The Global Study Lead ensures regulatory and procedural adherence and audit and inspection readiness; oversees outsourced study activities; collaborates with the Publication Team to publish study results; and tracks project performance to ensure completion on time, within scope, and within budget. The role builds and maintains collaborative relationships with cross-functional leaders, internal and external stakeholders, alliance partners, Pharma partners, and CROs to meet business goals and ensure operational excellence.

Requirements

• Bachelor's degree in Life Sciences or a related field.
• At least 8 years of experience managing the full lifecycle of sponsored studies and ensuring performance goals are met within scope, quality, budget, and timeline.
• In-depth knowledge and experience in Clinical Operations in product development.
• Clinical trial management knowledge and experience overseeing and conducting clinical trials in pathology/tissue diagnostics indication areas.
• Clinical trial management knowledge and experience overseeing and conducting Personalized Healthcare Solutions (PHCS)/Companion Diagnostic studies in partnership with a Pharma partner.
• Experience managing complex projects, using analytical judgment and innovative thinking to assess risks and solve difficult problems.
• Experience building and maintaining collaborative relationships with cross-functional leaders, internal and external stakeholders, and alliance partners, including Pharma partners or CROs.

Nice To Haves

• Advanced degree in Life Sciences or a related field.
• Ability to serve as a resource for less-experienced colleagues and provide functional guidance.
• Ability to lead moderately sized projects with manageable risks and resource requirements.
• Ability to solve complex problems, take a new perspective on existing solutions, and exercise judgment based on analysis of multiple information sources.

Responsibilities

• Lead the global study team and maintain accountability for study deliverables, quality, budget, and timelines.
• Collaborate with internal and external experts to develop high-quality study designs for sponsored studies.
• Prepare evidence-generation scenarios with Program Leadership and cross-functional teams to support global strategies and timeline and cost planning.
• Develop study documents, including Design Validation Plans, protocols, study training materials, study forms and templates, and study reports.
• Oversee planning and operational aspects of companion diagnostics studies sponsored by Pharma partners.
• Manage the study-level budget for assigned studies.
• Ensure adherence to regulations, guidelines, and standard operating procedures, and maintain audit and inspection readiness.
• Execute sponsored studies for assigned areas, for registrational and/or non-registrational purposes, across planning, start-up, conduct, and close-out phases.
• Oversee study activities outsourced to service providers such as CROs.
• Ensure study results are published in collaboration with the Publication Team.
• Oversee projects to ensure completion on time, within scope, and within budget; track performance against short- and long-term goals.
• Build and maintain collaborative relationships with cross-functional leaders, internal and external stakeholders, alliance partners, Pharma partners, and CROs.
• Assign tasks to study-team members and ensure delivery of those tasks.
• Provide oversight to external support, including CROs, consultants, and medical advisors.

Benefits

• A discretionary annual bonus may be available based on individual and Company performance.
• The position qualifies for company benefits detailed at the linked benefits page; specific benefits are not listed in the posting.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior