Director, Data Management

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

Full-time