Clinical Trial Manager
Manager: Senior Clinical Trial Manager
Department: Clinical Operations
Sangamo Therapeutics is a genomic medicine company building value with cutting-edge work across four distinct but complementary technology platforms – gene therapy, cell therapy, in vivo genome editing, and in vivo genome regulation. At Sangamo, we are passionate in developing genomic medicines to transform the lives of patients with serious diseases. We transform lives by building a robust, sustainable, differentiated, innovative, and high value genomic medicine pipeline that addresses patients with life-limiting conditions. Sangamo takes pride in being the first to edit endogenous human genes, first to treat patients with gene edited T cells, and first to treat patients with in vivo genome editing. Our top priority is to meet the needs of patients with commitment and compassion. Sangamo is a company where individuals can flourish, grow and develop their expertise.
We are seeking top talent to join our team. Let’s build a better future together.
The Clinical Trial Manager is accountable for the day-to-day operations of assigned clinical trials, including start-up, conduct and close-out activities. This position will perform required job duties with guidance to ensure trial timelines, costs and quality metrics are met and the trial is conducted in compliance with the study protocol, SOPs, and applicable regulatory requirements.
- Essential functions include, but are not limited to the following:
- Serve as the primary contact for managing protocol execution, including oversight of the CRO, service providers, and consultants that are involved in a clinical trial
- Lead cross-functional study team in support of study deliverables
- Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines
- Ensure clinical trials are managed and executed in accordance with ICH GCP, regulations, the protocol, and company-specific SOPs
- Assist in preparation and review of clinical documentation such as protocol, informed consent, Investigator Brochure, Clinical Monitoring Plan, Project Plan, case report form, statistical analysis plan, clinical study reports, and other study level documents
- Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviews
- Participate and respond to Quality Assurance and regulatory authority inspection audits
- Responsible for and participates in service provider selection process as a part of outsourcing activities.
- Responsible for the selection and study specific training of CRO study staff, monitors, investigational sites, and service providers
- In conjunction with legal group, facilitate the development of clinical trial agreements and other relevant documents
- Manage clinical trial budgets, providing ongoing financial reporting and projections
- Perform and manage data review process on an ongoing basis
- Negotiate and finalize site contracts and budgets
- Perform site visits including oversight, site qualification, initiation, monitoring and close-out visits, as needed
- Plan and coordinate Investigator Meetings
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
- Bachelor’s, or equivalent, degree in a scientific discipline
- 6+ years of clinical research experience, with at least 2 years’ experience in planning and managing clinical trials
- Understanding of pharmaceutical regulatory requirements, both US and abroad
- Demonstrated knowledge of ICH and GCP
- Ability to independently manage the initiation, monitoring and closing of clinical studies in accordance with Sangamo Therapeutics policies and procedures
- Understanding of clinical trial processes and experience in driving execution, from study start-up through study closure, (e.g., data management, safety, biostatistics, medical writing)
- Self-motivated, assertive and able to function independently or as part of a team
- Effective in selection of investigative sites, CROs, and vendors and management of external resources
- Highly effective communication and organizational skills
- Able to travel 25%-30%