Associate, Clinical Study Start-Up

Eli Lilly and Company • Boston, MA

1d

About The Position

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Job Responsibilities Verve Therapeutics, a wholly owned subsidiary of Eli Lilly and Company, is seeking a manager of clinical study start up that will support the strategy and implementation of start-up activities for clinical studies across all development programs. This position partners with cross-functional teams and CROs to provide input and guidance on all start up activities. Lead study start up activities for assigned projects, draft SSU documents, site regulatory document review and approval, and IRB/EC and regulatory submissions and approvals In partnership with clinical operations and other cross functional team members, the study start up lead will liaise with internal and external partners to distribute continuous status updates, as well as distributing weekly updates to internal and external partners Support the Clinical Operations team in the successful execution of clinical trials from protocol concept to clinical trial report, aligning with international ICH/Good Clinical Practice (GCP) guidelines/regulations and Standard Operating Procedures (SOPs) Manage IRB/EC and regulatory submission and approvals, including amendments and continuing reviews Collect and QC Regulatory document Green Light Packets for site activation Manage and archive central startup team tools and resources required to support startup team daily operations, communications, and records from study assignment to final handoff Set up and maintain SSU documents in internal TMF Maintain inspection-ready documentation Assist project teams with trial progress by updating study trackers Organize, attend, and actively contribute to project meetings such as internal team discussions, CRO meetings, support presentations, etc. Identify and implement best practices, seeking continuous process improvements as appropriate Liaise with sites, CROs, internal study team, at others, communicating clearly, effectively and in a prompt fashion Submit clinical documents in quality management system for management and team approval Request, manage, distribute, and track study supplies (Regulatory Binders, Study Reference Manuals, Patient Diaries, consumables & ancillary supplies, etc.) Strive to think ahead and be proactive concerning all responsibilities Perform all activities in compliance with applicable regulations, company policies and guidelines, including, but not limited to, prompt documentation of activities and maintaining all required applicable training Other duties as assigned

Requirements

• Bachelors degree in a science-related field; advance degree preferred
• 5+ years of clinical research / project management experience including clinical site, CRO, and/or sponsor experience
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Nice To Haves

• Direct experience in preparing and delivering Start-Up activities
• Familiarity with clinical trial operations, ICH, GCP Guidelines and other applicable regulatory requirements
• Experience working in a cross-functional team environment (e.g., Medical Affairs, Clinical Development, Regulatory, Quality Assurance, Data Management, Safety, Product Development, Finance)
• Understanding of complexities of study start up
• Strong interpersonal skills necessary to develop, guide, and maintain internal and external collaborator relationships
• Highly developed written and verbal communication skills, including presentation skills, ability to effectively articulate highly technical or complex concepts to audiences with differing levels of experience
• Demonstrated ability to effectively influence and manage within a matrixed organization
• Demonstrated ability to inspire, motivate, and mentor teams

Responsibilities

• Lead study start up activities for assigned projects, draft SSU documents, site regulatory document review and approval, and IRB/EC and regulatory submissions and approvals
• In partnership with clinical operations and other cross functional team members, the study start up lead will liaise with internal and external partners to distribute continuous status updates, as well as distributing weekly updates to internal and external partners
• Support the Clinical Operations team in the successful execution of clinical trials from protocol concept to clinical trial report, aligning with international ICH/Good Clinical Practice (GCP) guidelines/regulations and Standard Operating Procedures (SOPs)
• Manage IRB/EC and regulatory submission and approvals, including amendments and continuing reviews
• Collect and QC Regulatory document Green Light Packets for site activation
• Manage and archive central startup team tools and resources required to support startup team daily operations, communications, and records from study assignment to final handoff
• Set up and maintain SSU documents in internal TMF
• Maintain inspection-ready documentation
• Assist project teams with trial progress by updating study trackers
• Organize, attend, and actively contribute to project meetings such as internal team discussions, CRO meetings, support presentations, etc.
• Identify and implement best practices, seeking continuous process improvements as appropriate
• Liaise with sites, CROs, internal study team, at others, communicating clearly, effectively and in a prompt fashion
• Submit clinical documents in quality management system for management and team approval
• Request, manage, distribute, and track study supplies (Regulatory Binders, Study Reference Manuals, Patient Diaries, consumables & ancillary supplies, etc.)
• Strive to think ahead and be proactive concerning all responsibilities
• Perform all activities in compliance with applicable regulations, company policies and guidelines, including, but not limited to, prompt documentation of activities and maintaining all required applicable training
• Other duties as assigned

Benefits

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
• In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees