Study Lead, Lead Managment

McKesson

Full-time - Mid Level

Remote

1,001-5,000 employees

Merchant Wholesalers, Nondurable Goods

About the position

The Study Lead at Sarah Cannon Research Institute (SCRI) plays a pivotal role in the management of clinical research trials, serving as the primary responsible party and point of contact during the feasibility phase, clinical operations review, and document collection leading up to site selection. This position requires an experienced and fully competent individual who can operate independently or with minimal supervision. The Study Lead is tasked with resolving a diverse range of complex problems by collaborating with sponsors, Contract Research Organizations (CROs), and internal stakeholders to expedite the Lead Management process. Additionally, the Study Lead will assess site capabilities and complete feasibility questionnaires on behalf of SCRI's strategic sites, ensuring that all essential documents required for study activation are obtained in a timely manner. The role also involves presenting findings during operational review meetings, thereby contributing to the overall success of clinical trials. In this capacity, the Study Lead will support essential education and training for sponsors and CROs through kickoff calls and emails, providing capabilities presentations and addressing any client questions or concerns. The individual will also participate in clinical operational reviews and site calls to evaluate study opportunities. Conducting comprehensive feasibility analyses for clinical study leads using internal data and personnel as resources is a critical responsibility. The Study Lead will collaborate with cross-functional teams to gather necessary data and information for feasibility analysis and maintain a tracking system for the study lead lifecycle. Other duties may be assigned as needed, reflecting the dynamic nature of clinical research management.

Responsibilities

• Serve as the primary responsible party and point of contact during clinical research trial feasibility and operations review.
• Provide resolutions to complex problems by collaborating with sponsors, CROs, and internal stakeholders.
• Assess site capabilities and complete feasibility questionnaires for SCRI strategic sites.
• Coordinate with sponsors, CROs, and internal teams to obtain essential documents for study activation.
• Support education and training for sponsors/CRO via kickoff calls and emails.
• Conduct comprehensive feasibility analyses for clinical study leads using internal resources.
• Collaborate with cross-functional teams to gather necessary data for feasibility analysis.
• Maintain a tracking system for the study lead lifecycle.
• Attend site calls to review study opportunities and present findings during operational review meetings.

Requirements

• Bachelor's Degree in a relevant field.
• 4+ years of relevant experience within clinical research.
• At least 1 year of trial management experience required.
• Strong attention to detail and ability to meet aggressive timelines.
• Excellent verbal and written communication skills.
• Documented training and knowledge of current FDA Regulations, GCP, and ICH guidelines in clinical trials.
• Ability to collaborate effectively with study teams and external partners using negotiation skills.
• Strong computer skills, including proficiency in Microsoft Excel, Word, PowerPoint, and Outlook.
• Ability to work in a fast-paced environment.

Benefits

• Comprehensive benefits to support physical, mental, and financial well-being.
• Competitive compensation package including base pay, annual bonuses, and long-term incentive opportunities.