Senior Clinical Trial Manager at Encoded Therapeutics

South San Francisco, California, United States -

Full Time

Start Date

Immediate

Expiry Date

04 Apr, 26

Salary

158000.0

Posted On

04 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Trial Management, FDA Regulations, ICH Guidelines, Good Clinical Practices, Data Management, Problem Solving, Organizational Skills, Interpersonal Skills, Written Communication, Vendor Management, Study Planning, Monitoring, Training, Collaboration, Technical Document Writing, Rare Disease Experience

Industry

Biotechnology Research

Description

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 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 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 Preferred Qualifications Rare disease, gene therapy program and/or CNS disease experience Previous independent on-site monitoring experience For candidates based in the SF Bay Area, the expected base salary range for this role is $129,000–$158,000. For candidates based outside the SF Bay Area, the expected base salary range for this role is 119,000 - 145,000. The actual base pay offered will depend on factors such as experience, skills, and location. Employees in this role are also eligible to be considered for an annual bonus and receive stock option grants. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, length of experience within the industry, education, etc. 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. Encoded is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Encoded is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Encoded are based on business needs, job requirements and individual qualifications, without regard to race, religion or belief, color, national origin, gender, status as a protected veteran, status as an individual with a disability, or any other status protected by the laws or regulations in the location in which we operate. Encoded will not tolerate discrimination or harassment based on any of these characteristics. Encoded encourages applicants of all ages. If you need assistance or an accommodation due to a disability, you may call us at +1 650-491-0272. #LI-CD

Responsibilities

The Senior Clinical Trial Manager will manage clinical trial activities for Dravet Syndrome development programs, ensuring compliance with regulations and timelines. Responsibilities include site selection, training, oversight monitoring, and vendor management.