The Position

Verve 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.

Job 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, complying 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 timely 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, timely documentation of activities and maintaining all required applicable training
• Other duties as assigned

Qualifications

• Bachelor's 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
• 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 skill set 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