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.
Reporting to the Senior Director of Biometrics the Associate Director/Director of Clinical Data Management will be responsible for leading and managing all Clinical Data Management (CDM) activities to meet corporate timelines and objectives. The Director of CDM will be responsible for building and leading the CDM function and for setting strategies for the CDM function at Encoded.
- Develop and implement the vision and strategic direction for CDM across all Encoded clinical trials
- Serve as the Clinical Data Manager for multiple clinical trials
- Participate in the planning and protocol review of all Encoded clinical studies to ensure optimal CRF and EDC design
- Partner with Clinical and Biometrics to develop comprehensive DMPs covering all aspects of data collection, processing, reconciliation, review, and storage
- Oversee EDC and ePRO builds (including development of eCRFs specs, variable naming conventions, edit checks, completion guidelines, etc.)
- Implement and document EDC and ePRO UATs
- Works closely with other Biometric functions to monitor all incoming data during study.
- Plan and facilitate data review meetings in conjunction with other biometric functions (biostats and statistical programming)
- Lead or direct discrepancy management
- Plan and facilitate database lock
- Manage vendors contracted to support CDM activities for Encoded’s clinical trials.
- Develop standardize work practices and procedures in alignment with CDISC standards, GCP, GCDMP and ICH guidelines
- Perform resource planning and budget forecast for CDM related activities.
- Manage timelines for all CDM activities to support corporate objectives.
- Lead the design of the clinical databases/CRFs and ensure that they support the clinical study objectives
- Ensure complete and accurate CDM documentation such as eCRF specifications, eCRF completion guidelines, annotated CRFs, data validation specifications, data transfer agreements, and data management plans
- Ensure all CDM documentation are complete, accurate and in an inspection-ready state.
- Act as team SME for key systems and processes, and process enhancement efforts
- Foster and promote the long-term development of the CDM function by working closely with other functional groups within Encoded
- Maintain current professional knowledge of regulatory requirements and industry best practices in relevant areas of CDM, technology advances, and quality assurance
- Recruit, develop, and motivate CDM staff as required
- BS/BA and/or MS degree or equivalent combination of education/experience in science or health-related field with 8-10+ years of direct data management experience (Rare disease experience highly desirable)
- Strong knowledge of CDM processes, EDC systems (RAVE preferably), database programming, quality management and technology advancements in the field of data management
- Experience with statistical programming packages preferred (SAS or R)
- Experience with electronic patient reported outcomes preferred
- Experience with the review, reconciliation, and cleaning of neurodevelopmental, behavior, and motor assessments preferred
- Understanding of the MedDRA and WHODRUG coding processes.
- Knowledgeable in GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and recommended CDM Best Practices
- Strong track record of line management and supervisory experience of CDM staff, shown leadership skills to lead and inspire CDM staff including consultants
- Outstanding problem-solving abilities and influencing/negotiation skills
- Excellent interpersonal, communication, and leadership skills
- Logical thinking, attention to detail and accuracy, good organizational skills, and problem-solving abilities
- Ability to prioritize and to adapt quickly to changing business conditions with a positive attitude
- Willing to travel if required
- 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.