Manager, Data Management

Asklepios Biopharmaceutical, Inc. (Askbio); Durham (NC); On-site; USD 110,000 - 160,000; Full time

Job summary

AskBio Inc. in RTP, North Carolina, seeks a Manager, Clinical Data Management to oversee DM activities across external vendors and in-house teams. You will design and program databases, oversee UAT, data review, and database locks, and ensure data integrity for sponsored trials.

The role reports to the Senior Director, Data Management and requires leadership in a matrix organization, with strong collaboration across functions to support regulatory submissions.

Qualifications

• Bachelor’s degree in life sciences or related field with a minimum of 6 years’ clinical trial related data management experience.
• Familiarity with clinical trial database packages such as Veeva EDC, Medidata Rave.
• Knowledge of CDASH/SDTM standards and CDISC standards for data management and regulatory compliance.
• Ability to operate and lead in a matrix organization with diverse stakeholders.

Responsibilities

• Oversee all data management activities outsourced to external suppliers or conducted in-house, from study setup to database lock.
• Plan, coordinate, and deliver high-quality clinical trial data in a timely manner for assigned projects.
• Serve as DM point of contact for internal and external study team members with senior DM oversight.
• Provide quality and project oversight over third-party vendors responsible for DM deliverables.
• Lead content gathering for EDC and collaborate on other data collection systems.
• Represent DM on cross-functional project and submission teams.
• Support Health Authority inspections and audits.
• Manage changes to database design and data requirements due to protocol amendments.
• Develop, troubleshoot, and maintain programs for database design, validation, and analysis.
• Contribute to development of SOPs and guidance documents.

Skills

Leadership in matrix org

Regulatory understanding

Communication skills

Education

Bachelor’s degree in life sciences or related field

Tools

Veeva EDC

Medidata Rave

SAS

SQL

Power BI

Excel

Job description

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.

This position will report to the Senior Director, Data Management.

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 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 in an environment that requires diverse educational and functional expertise

Preferred Education, Experience and Skills

• Good knowledge of CDASH® standards and how they support CDISC® standards (SDTM). Hands on experience of confirming database design and DM principles are consistent with all types CDASH® of and their support of SDTM
• Experience managing multiple sources of data
• Experience identifying and mitigating potential risks in the DM space; problem resolution skills to solve errors/inconsistencies found in data processing to reduce risk to data integrity and validity
• Experience in managing gene therapy studies
• Excellent verbal and written communications skills; able to communicate proactively and effectively
• Utilizing and developing SAS, SQL, Power BI, Excel and other analytical tools to support clinical data review, identifying data trends and discrepancies, and monitoring study performance metrics

AskBio Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job-related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at [phone] or sending us an email at [e-mail].