Manager, Data Management

askbio; Durham (NC); On-site; USD 110,000 - 160,000; Full time

Job summary

AskBio Inc. in RTP, North Carolina, is seeking a Manager, Clinical Data Management to oversee all data management activities for clinical trials.

You will manage database design specifications, programming, UAT, deployments, data review, and database locking to ensure data quality and integrity across AskBio sponsored trials. The role requires leadership in coordinating data management plans, vendor oversight, and collaboration with cross-functional teams, while supporting Health Authority

Qualifications

• Bachelor's degree in life sciences or related field with at least 6 years of data management in clinical trials.
• Experience with Veeva EDC and Medidata Rave in trial data management.
• Knowledge of GCP regulations and data integrity standards.

Responsibilities

• Oversee end-to-end data management activities for externally sourced or in-house studies.
• Develop and validate databases, UAT, and data archiving.
• Collaborate with cross-functional teams and support inspections.

Skills

Data management oversight

GCP compliance

Server/database systems

Vendor management

Education

Bachelor's degree in life sciences

Tools

Veeva EDC

Medidata Rave

Job description

AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life‑saving medicines and changing lives. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical‑stage pipeline that includes investigational therapeutics for congestive heart failure, limb‑girdle muscular dystrophy, multiple system atrophy, Parkinson's disease, and Pompe disease. AskBio's gene therapy platform includes Pro10™, an industry‑leading proprietary cell line manufacturing process, and an extensive array of capsids and promoters. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, Scotland, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre‑clinical and clinical testing.

Our vision

Pioneering science to create transformative molecular medicines.

Our mission

Lead innovative science and drive clinical outcomes to transform people's lives.

Our principles

• Advance innovative science by pushing boundaries.
• Bring transformative therapeutics to patients in need.
• Provide an environment for employees to reach their fullest potential.

Our values

• Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.
• Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.
• Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers.
• Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action.
• Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what's right in every situation. Make clear commitments and follow through.

Position Summary

We have an opportunity for Manager, Clinical Data Management to join the AskBio team in our RTP, North Carolina, location and be part of our continued success!

The Manager, Clinical Data Management, provides oversight of all data management activities outsourced to external suppliers and/or conducted in‑house, from study set‑up, to conduct and close out. including but not limited to database design specification development, database design programming, database User Acceptance Testing (UAT), database deployment to research sites, data review and database lock and data archiving. Therefore, ensure the quality and integrity of all databases used in AskBio sponsored trials.

Job Responsibilities

• Ensure that end-to-end Data Management activities are conducted in accordance with high ethical and quality standards, all applicable GCP regulations and company procedures
• Provide oversight of all data management activities outsourced to external suppliers and/or conducted in‑house, including but not limited to Data Management Plan, database specification development, database design programming, database User Acceptance Testing (UAT), database deployment to research sites, data review, coding and database locks
• Efficiently plan, coordinate, and deliver complete, high quality and reliable clinical trial data in a timely manner for assigned projects
• Serve as the DM point of contact for internal and external study team members with minimal oversight from senior data management resources
• Provide strong quality and project oversight over third‑party vendor responsible for data management deliverables
• Take a leadership role to gather content and integration requirements for EDC and close collaboration with partners supporting other data collection systems (Non‑EDC Data)
• Represent DM on cross‑functional project teams & submission teams
• Provide support for Health Authority inspections and audits
• Effectively manage changes to database design and data management requirements as necessary due to protocol amendments and changes to overall clinical development programs
• Develop, troubleshoot, and maintain complex programs and utilities leading to database design, creation, validation, & use as well as clinical trial statistical analysis
• Participate in the development of departmental standard operating procedures, working procedures and guidance documents

Minimum Requirements

• Bachelor's degree in life sciences, statistics, biostatistics, mathematics, computer science, biotechnology or related field with a minimum of 6 years' clinical trial related data management experience
• Prior use of and/or familiarity with clinical trial database packages such as Veeva EDC, Medidata Rave
• Significant knowledge of the drug development process, clinical trial methodology, data management & statistics