Senior Clinical Trial Manager

Encoded Therapeutics•South San Francisco, CA

4d•Hybrid

About The Position

Encoded Therapeutics Inc. is a biotechnology company advancing precision medicines for a broad range of genetic disorders. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery. We focus on delivering life-changing advances for individuals with genetic disorders not addressable with current approaches. For more information, please visit www.Encoded.com. Position details Reporting to the Associate Director of Clinical Operations, Senior Clinical Trial Manager will be responsible for the implementation of clinical trial activities for the Dravet Syndrome development programs. Working closely with investigative site personnel, CROs, and other study vendors the CTM/Sr. CTM will assist the Clinical Team with the conduct of clinical trial activities in accordance with Standard Operating Procedures and all applicable regulations governing the conduct of clinical trials. Workplace Model: San Francisco Bay Area (Hybrid) or Remote

Requirements

BS/BA and/or MS degree bachelor’s degree or equivalent combination of education/experience in science or health-related field
8 years relevant experience with a bachelor's degree or 6 years of experience with a masters degree, inclusive of 1-2 years directly managing others effectively and/or effective clinical study management, monitoring, and in developing study-related documents.
Expert knowledge and understanding of FDA and ICH Guidelines, Good Clinical Practices (GCP), medical terminology, and clinical trials
Proficiency with word processing, spreadsheet, database, and presentation software and with filing (archiving) systems
Demonstrated problem solving abilities and strong organizational skills
Must be self-motivating, prioritize and manage a large volume of work, and show attention to detail
Strong interpersonal skills with reputation for collaboration with colleagues; influencing up, down and across the organization
Demonstrated success working with key external stakeholders including, KOLs and Therapeutic Area Experts, Site Personnel, including Principal Investigators, Study Coordinators and managing external partners and vendors.
Outstanding written communication skills including writing technical documents, such as protocols, protocol amendments, informed consent, and other trial-related documents

Nice To Haves

Rare disease, gene therapy program and/or CNS disease experience
Previous independent on-site monitoring experience

Responsibilities

Manage defined aspects of clinical trials to ensure trials are completed on time and in compliance with SOPs, FDA regulations and ICH/GCP guidelines
Perform the activities associated with the implementation and monitoring of clinical trials such as development of study plans and materials
Work with Medical Monitor and Sr. Director of Clinical Operations to select investigative sites, train investigators and investigative site staff, and prepare materials for investigator meetings
Assist with maintaining study timelines including identifying and communicating trial issues that will impact budget, resources and/or timelines
Review and critique electronic CRFs for accuracy and completeness; oversee data discrepancy management and training as needed
Conduct oversight monitoring activities as needed
Manage external Vendor partners. Includes review of invoices for accuracy compared to vendor contract; may aid in the development of technical specifications for vendors (e.g. scope of work)
May be the operational lead on a trial under the supervision of Sr. Director of Clinical Operations
Assist in creating and implementing departmental procedures in compliance with industry standards and regulatory requirements
Travel (including international) up to 20%
Contribute to wider organizational goals and/or activities as assigned

Benefits

Comprehensive benefits package, including competitive employer premium contributions
Meaningful stock option grants
PTO, sick time, and holiday pay
Generous Parental Leave program
Pre-tax medical and dependent care programs
STD, LTD, Life and AD&D
Professional development opportunities
Team-building events
Fully stocked kitchen
Purple Tie dry cleaning service
Fitness center
Employees (and their families) may obtain medical, dental, vision and basic life insurance benefits through the company and enroll in our company's 401k plan. Employees will also accrue vacation time off and paid sick time off and may become eligible for paid parental leave. Employees will also enjoy designated paid holidays throughout the calendar year.