Clinical Data Management Lead — Secondment

Asklepios BioPharmaceutical, Inc. (AskBio); North Carolina; On-site; USD 120,000 - 160,000; Full time

Job summary

AskBio Inc. in North Carolina is seeking a Manager, Clinical Data Management for a secondment to join our team at the RTP site. The role oversees data management activities for trials, including external vendor coordination, database design, UAT, data review and database lock to ensure data integrity.

The position reports to the Senior Director, Data Management and requires leadership in a matrix organization, working with cross-functional teams to support regulatory submissions and inspections.

Qualifications

• 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 and relevant regulatory requirements for drug approval
• Demonstrated ability to operate and lead in a matrix organization, building successful working relationships and effective stakeholder management

Responsibilities

• Ensure 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 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
• 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

Skills

Data management

SAS

SQL

Power BI

Excel

Global trial data

Education

Bachelor’s degree in life sciences or related field

Tools

Veeva EDC

Medidata Rave

SAS

SQL

Power BI

Excel

Job description

AskBio Inc. in North Carolina is seeking a Manager, Clinical Data Management for a secondment to join our team at the RTP site. The role oversees data management activities for trials, including external vendor coordination, database design, UAT, data review and database lock to ensure data integrity.

The position reports to the Senior Director, Data Management and requires leadership in a matrix organization, working with cross-functional teams to support regulatory submissions and inspections.