At Arbutus we have a vision: to cure chronic Hepatitis B virus (HBV). We have a dedicated and innovative team and we are uniquely positioned to transform the HBV treatment landscape. We are developing a portfolio of drug candidates with multiple mechanisms of action that we believe will result in a combination therapy to cure HBV. Arbutus Biopharma has offices and research facilities in Warminster, Pennsylvania.
About the role:
Arbutus has an opportunity for a seasoned Director, Data Management to join our team in Warminster. Reporting to the Vice President, Clinical Operations, the Director, Data Management will be responsible to manage Arbutus’ clinical data systems, processes and resources in support of our clinical team and corporate objectives. The Director, Data Management will be located in our Warminster office.
If you are looking to join a team with a proven track record in drug discovery and development, and are as passionate as we are, we want to hear from you.
Responsibilities will include:
• Responsible for all data management tasks within Arbutus Clinical Development
• Ensures data management systems and processes for all clinical projects are in compliance with 21 CFR Part II requirements and GCDM Practices
• Oversees the conduct of Arbutus data management through external third-party vendors, labs & CROs
• Actively manages studies including database build and migrations, eCRF tracking, data review and validation, SAE reconciliation, MedDRA and WHO-DD coding, query management and tracking, and ongoing review of CRO data
• Leads internal data quality review
• Leads user acceptance testing (UAT) for all EDC and IXRS systems implementation
• Oversees the implementation of, integration with, and transfers from multiple electronic systems (eCRF, IXRS, lab, etc.)
• Oversees contract Data Managers and/or direct reports
• Oversees development, implementation and maintenance of data management SOP’s and Work Instructions
• Assesses scope of work and participates in RFP bid reviews, reviews and verifies invoices, manages vendor contracts and data management budget
• Ensures studies are conducted in accordance with GCP and ICH Guidelines
• Contributes to development of related regulatory documents including DSURs, IB Updates, or other requests for data for Health Authorities
• Other related duties as assigned.
• BA/BS/MS in a Life Sciences related discipline and a minimum of 12 years directly related experience in Data Management or equivalent combination of education and experience within a biotechnology or pharmaceutical environment
• In depth knowledge and understanding of all data management aspects, with a track record of successfully managing programs to completion
• A hands-on leader, independent and highly driven to deliver results
• Knowledge of ICH E6, FDA and EMEA regulations; stays current with changing regulations
• Outstanding communication skills with ability to interact effectively with the project and clinical study teams
• Innovative thinker willing to take measured risks within the bounds of compliance to achieve clinical success
• Embraces process simplification and/or continuous improvement managing any change effectively
• Capability to negotiate difficult matters and to influence decision makers internally and externally
• Demonstrates a clear understanding of overall company strategy; aligns to corporate strategy and vision through words and actions
• Has a track record of taking a leadership role while introducing new ideas that have significant organizational/team impact; proactive, strong problem solver
• Experience setting up the data management function in a biotech environment strongly preferred