Manager, Clinical Study Start Up - Verve Therapeutics, Inc.
Boston, MA
About the Job
The Company
Verve is a clinical-stage genetic medicines company established with a mission to solve the global health epidemic of cardiovascular disease. Founded by world-leading experts in cardiovascular medicine, human genetics and gene-editing, Verve is pioneering a new approach to the care of cardiovascular disease, potentially transforming treatment from chronic management to single-course gene editing medicines. The company's initial three programs – VERVE-101, VERVE-102, and VERVE-201 – target genes that have been extensively validated as targets for lowering low-density lipoprotein cholesterol (LDL-C), a root cause of cardiovascular disease. VERVE-101 and VERVE-102 are designed to permanently turn off the PCSK9 gene in the liver and are being developed initially for heterozygous familial hypercholesterolemia (HeFH) and ultimately to treat atherosclerotic cardiovascular disease (ASCVD) patients not at goal on oral therapy. VERVE-201 is designed to permanently turn off the ANGPTL3 gene in the liver and is initially being developed for homozygous familial hypercholesterolemia (HoFH) and ultimately to treat patients with refractory hypercholesterolemia. In 2023, Verve was named a Top Place to Work by The Boston Globe for the third consecutive year. Verve is headquartered in Boston, Massachusetts.
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
EEO Statement
Verve Therapeutics is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. If you have a disability or special need that requires accommodation, please let us know.
Recruitment & Staffing Agencies
Verve Therapeutics does not accept agency resumes unless contacted directly by internal Verve Talent Acquisition. Please do not forward resumes to Verve employees or any other company location; Verve Therapeutics is not responsible for any fees related to unsolicited resumes.