Job 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 Head of Clinical Data Management, the Senior Manager of Clinical Data Management will be responsible for the daily data management tasks to meet corporate timelines and objectives. The Sr. Manager will ensure the accuracy, consistency, completeness, and high quality of the clinical database. The role will work closely with cross-functional teams on the clinical development program.
Workplace Mode l: Remote
Responsibilities
Serve as the Clinical Data Manager for multiple clinical studies
Participate in the protocol review of assigned studies to ensure optimal CRF design
Partner with Clinical and Biometrics to develop comprehensive DMPs covering all aspects of data collection, processing, reconciliation, review, and storage
Lead the design and build of the clinical databases/CRFs and ensure that they support the clinical study objectives
Responsible for user acceptance testing, including authoring and/or executing scripts
Oversee all aspects of data collection and review, including the following: monitor data flow, perform discrepancy management and data review and activities, lead data review meetings, plan and facilitate database lock
Manage data transfers with data providers, support SAE reconciliation, and manage local lab reference range documentation
Manage vendors contracted to support CDM activities for Encoded’s clinical trials.
Manage timelines for all CDM activities to support corporate 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 inspection-ready state.
Act as team SME for key systems and processes, and process enhancement efforts
Contribute to program deliverable timeline creation and project re-forecasting
Performs additional duties as assigned
BS/BA and/or MS degree bachelor’s degree or equivalent combination of education/experience in science or health-related field with 8 years of direct data management experience without a masters, or six years experience with a MS. (Rare disease experience highly desirable)
Strong knowledge of CDM processes, EDC systems (Medrio and Medidata RAVE preferably), database programming, and quality management
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
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 adapt quickly to changing business conditions with a positive attitude
Willing to travel if required
For candidates based in the San Francisco Bay area, the anticipated salary range is $145,000 - 170,000. The anticipated salary range for candidates who will work remote is $130,000 - $155,000. The final salary offered to a successful candidates 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. Encoded Therapeutics is a multi-state employer and this salary range may not reflect positions that work in other states.
A hired applicant may be eligible for an annual bonus as well as equity under the company’s stock plan.
- 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.
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