Senior Clinical Data Manager

Summary

Join Encoded Therapeutics as a Senior Manager of Clinical Data Management, reporting to the Head of Clinical Data Management. You will be responsible for the daily data management tasks, ensuring data accuracy and quality across multiple clinical studies. Collaborate with cross-functional teams, lead database design and build, and oversee data collection and review processes. Manage vendors, timelines, and documentation, acting as a subject matter expert for key systems. This remote position requires a BS/BA or MS degree in a science or health-related field, along with significant data management experience and expertise in relevant software and regulatory standards. The salary range varies based on location and experience.

Requirements

• 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
• Strong knowledge of CDM processes, EDC systems (Medrio and Medidata RAVE preferably), database programming, and quality management
• 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

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

Preferred Qualifications

• Rare disease experience highly desirable
• 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

Benefits

• 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