Clinical Trial Manager/Sr. Clinical Trial Manager Req # 2073
South San Francisco , CA 94080
Posted 2 months ago
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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 visitwww.Encoded.com.
Reporting to the Senior Director, Clinical Operations, the Clinical Trial Manager (CTM)/Sr. CTM 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.
- 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
- Bachelors degree in science or health-related field.
- 3 or more years of relevant experience, to include the demonstrated ability to provide guidance and direction to others effectively and/or demonstrated experience in clinical study management, monitoring, and in developing study-related documents.
- Previous independent on-site monitoring experience
- 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.
- 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.
- Masters degree in science or health-related field
- 5 or more years of relevant experience, inclusive of 1-2 years directly managing others effectively and/or effective clinical study management, monitoring, and in developing study-related documents.
- Rare disease, gene therapy program and/or CNS disease experience
- 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
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.