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Durham, North Carolina, United States
Onsite
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.
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 (919) 561-6210 or sending us an email at careers@askbio.com.
Agencies: Please do not contact any employee at AskBio about this requisition. Any resume submitted by a recruitment agency to any employee at AskBio, through any medium, will be deemed the sole property of AskBio unless the agency was engaged by AskBio Talent Acquisition team to recruit for that position. All agencies must have a prior executed service agreement with AskBio prior to any search engagement. If a candidate who was submitted outside of the AskBio agency process is hired by AskBio, no fee or payment of any kind will be paid to the agency.