Job Description
Job Description
Job Title:
Director, Data Management
Reports to (title):
Vice President, Head of Clinical Operations
Solid Summary:
Solid Biosciences is a life science company focused on advancing a portfolio of neuromuscular and cardiac programs, including SGT-003, a differentiated gene therapy candidate for the treatment of Duchenne, AVB-401, a gene therapy program for the treatment of BAG3 mediated dilated cardiomyopathy, AVB-202-TT, a gene therapy program for the treatment of Friedreich’s Ataxia, and additional assets for the treatment of fatal cardiac diseases. Solid aims to be the center of excellence across a given disease spectrum bringing together those with expertise in science, technology, disease management, and care. Patient-focused and founded by those directly impacted, Solid’s mandate is to improve the daily lives of patients living with these devastating diseases.
Position Summary:
The Director Data Manager position requires deep understanding of data management principles, data governance and best practices with the ability to function independently or in collaboration with a group, to manage the full lifecycle from study start-up through database archive. This position may be responsible for managing data managers and has direct oversight and collaboration of CROs and cross-functional teams for database design specifications, validation, maintenance, and data cleaning. The position reports to the VP Head of Clinical Operations.
Key Duties & Accountabilities:
- Oversee all data management activities for programs performed in-house or by CROs
- Function as study DM liaison with cross-functional team members, both internal and external, to ensure quality on-time data management deliverables.
- Oversight of CROs/vendors to ensure efficiency, quality, and consistency for all data management deliverables across assigned program
- Leadership of Data Management team with knowledge and proficiency in data analysis tools and programming languages
- Collaborate with Biostatistics and programming function to ensure overall data integrity and output per established standards
- Lead the design and implementation of data architecture and data warehouses
- Monitor and improve data quality by identifying and addressing data inconsistencies, errors and redundancies across programs
- Oversee integration of data from multiple sources and ensures data consistency across systems
- Oversee User Acceptance Testing (UAT) Plan for database and edit check specifications testing
- Lead and participate in User Acceptance Testing (UAT) for database, edit check specifications
- Oversee data review for overall consistency, data trends and issues and collaborate with CRO on development and implementation on remediation plan(s) and timelines
- Oversee vendor data reconciliation (e.g., IVRS, laboratory data, SAE Reconciliation) within the clinical database(s) to include QC of queries/query responses, manual listings, external data reconciliation, metrics, and custom reports as required throughout the study
- Track data management activities and issues and ensure follow-up/completion to resolution.
- Act as Subject Matter Expert in assigned area(s).
- Oversee creation and review of Data Management SOPs, WIs, and training materials
- Maintain internal data management study documentation to audit ready status
- Perform other duties as requested by management
Core Competencies Required:
- Subject matter expert in Data Management related tools
- Demonstrates well-developed instincts and problem-solving skills in all areas of data management
- A complete understanding and application of principles, concepts and practices of clinical research procedures and Good Clinical Practice (GCP) is required
- Experience in Rare Disease Drug Development preferred and familiarity with gene and/or cell therapy
- Experience in BLA filing and inspection readiness
- Experience with all phases of clinical drug development including global regulatory submissions preferred
- Strong communication, organizational and interpersonal skills are required
- Independent decision-making and analytical skills are required to operationalize and move the clinical trials forward
- Ability to prioritize tasks and resources, meet deadlines, and be flexible to changing priorities
- Strong understanding of clinical efficacy and safety data, interpretation of tables and listings, and analysis to ensure clinical data integrity
Knowledge: Education, Experience, & Skills:
- BA/BS, preferably in the scientific/healthcare or related field
- 10+ years Lead Clinical Data Management experience in Pharmaceutical or Biotech industry
- Knowledge of medical terminology
- Working knowledge of GCP, FDA, ICH, CDISC, CDASH regulations, SDTM, ADAM datasets and relevant guidelines
- Detail oriented, ability to multitask with strong prioritization, critical thinking and planning and organizational skills
- Ability to communicate data management standards, developments, and challenges in an accurate, concise, and consistent manner to both internal and external stakeholders
- Excellent verbal and written communication skills
- Proficient working knowledge of EDC platforms such as Medidata Rave, Oracle Clinical Inform, various IVRS/IRT solutions, Excel, etc.
- Experience/Knowledgeable about clinical data management outsourcing with full service global CROs and niche providers
- Ability to assess protocol amendments for database updates
Travel Commitment:
None
Role Location
(HQ, Hybrid, Remote, NC, etc.)
HQ, Hybrid or Remote