About SwanBio Therapeutics

SwanBio is a privately held biotechnology company focused on the discovery and development of innovative gene therapy products for the treatment of central nervous system (CNS) disorders and diseases. SwanBio has a deeply experienced leadership team and is building an open, innovative culture that trusts its people, processes and science to deliver scientific, clinical and business success.SwanBio’s lead investor is Syncona, a premiere investment partner focused on building companies delivering transformational healthcare treatments. Syncona has a deep pool of capital and they are established leaders in the development of genetic medicine. In particular, they present a legacy of success in long term investment strategies for companies in the Gene and Cell Therapy space. Our goal is to become a world-leader in treating neurodegenerative diseases. With locations in Philadelphia and Boston, the SwanBio Team is building a strong pipeline of gene therapy development programs with a directed focus on critical unmet medical needs for CNS diseases. SwanBio offers all team members both competitive compensation and benefits.

The Opportunity

The Associate Director / Director, Data Management is an influential leader responsible for the strategy and delivery of global Data Management strategy for all studies, programs, and therapeutic areas. The role will provide day-to-day leadership for clinical data management in the areas of project management, medical coding, data systems and quality, vendor oversight and is accountable for the implementation of data strategy at the program and study-level, and overall project delivery. The director of data management will be the key point person for operational excellence in partnership with Biostatistics, Clinical Operations, R&D Strategy and other functional areas throughout the company. This person will be responsible for developing policies, standards and processes for data management. You should not only be able to oversee and build functions but also provide “hands on” support for delivery of work and work products.

Key Responsibilities

In this role you will:

• Ensure that adequate resourcing is available internally and externally through strategic partnerships to meet milestones and performance/quality requirements across all programs
• Partner with Biostatistics and Clinical Operations to ensure excellence in all aspects of statistical trial data acquisition and reporting.
• Partner with functional areas within R&D to ensure alignment and collaboration on work streams and initiatives that impact all of R&D.
• Support Early Clinical Development through Late Stage Development by ensuring that Data Management processes, standards, templates and best practices are developed and applied to fit for purpose to meet program needs.
• Manage, coach, and support staff in order to develop excellence.
• Be responsible for qualifying and managing external service providers and for managing internal data management and programming staff and/or in-house consultants.
• Have direct responsibility or through oversight of external service providers for the development, implementation and maintenance of appropriately validated systems/applications for clinical data management, and for providing data management support for clinical trials.
• Be responsible for the development of data acquisition standards and practices with keen attention to quality and regulatory compliance
• Participate in clinical trial planning efforts as key contact for data acquisition and delivery.

• Lead Data Management Activities in Development and Execution of Clinical Trials
• Oversee day-to-day activities of data management CROs working on studies within a program.
• Participate in clinical development taskforces and initiatives around standardization, quality by design, and technology implementation.
• Serve as an active member of Study Teams and the Clinical Subteam.
• Work with other functions to manage timelines and ensure that clinical data management deadlines are met.
• Liaise with third-party vendors such as CROs and central laboratories in support of timelines and data-related deliverables
• Work with IT database builders to develop CRFs, databases, edit checks and reports.
• May define database and edit check specifications to support the protocol and analyses.
• Develop UAT requirements for new study databases and revisions.
• Participate in database testing in accordance with UAT Plan.
• Create and maintain data management documentation in the Trial Master File (TMF).
• Regularly review and query clinical trial data as indicated in the DMP and Data Review Plan.
• Help design listings in support of data management, clinical and medical reviews of data.
• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics, audit reports, and input from project team members and other stakeholders.
• Train other personnel on study-related items and data management principles, as needed.
• Ensure coordination with Pharmacovigilance on serious adverse event reconciliation.
• Review and provide feedback on draft protocols, Statistical Analysis Plans, CSRs and other documents as required.
• Participate in the development and maintenance of Standard Operating Procedures (SOPs) and Work Instructions related to data management and programming activities.
• Develop CRF standards.
• Train and/or supervise the daily responsibilities of more junior staff as assigned.

Basic Requirements:

• Bachelor’s Degree with 7- 10+ years in the pharmaceutical /clinical research industry.
• 5+ years of experience in Data Management in the pharmaceutical/clinical research industry with experience in a leadership role with increasing levels of responsibilities.
• Knowledge Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
• Knowledge of current and emerging trends in data management of clinical trial data.
• Familiarity with different dataset structure.
• Knowledge of the drug development process.
• Knowledge and understanding of the principles, concepts, methods and standards of Clinical Data Management (CDM).
• Knowledge of regulations related to CDM and clinical research such as GCP, ICH Guidance, 21 CFR, CDISC and SDTM data model

Skills

• Ability to direct and manage the activities of outside Data Management vendors
• Possess a thorough understanding of clinical data, efficiencies in guiding its collection, oversight of its management and assurance of its integrity in the clinical trial process.
• Proficient computer skills across multiple applications such as word processing, spreadsheet and presentation software.
• Skilled in the use of database management, external data streams (e.g. EDC, IRT, ePRO, central labs).
• CRF design/database design/data review skills.
• Attention to detail.
• Verbal and written communication skills.
• Interact effectively with a wide variety of internal personnel and outside vendors.
• Ability to identify new or changing business needs and take actions to meet them
• Results driven and solution seeking
• Possess the mindset of no job too big or too small

About the Benefits:

The successful candidate will enjoy a competitive base salary and the opportunity to participate in incentive compensation programs including bonus and stock option plans. Additionally, SwanBio Therapeutics offers all team members a comprehensive benefits program including medical, dental, vision care, 401(k), paid vacation and holiday time.

SwanBio Therapeutics is an equal opportunity employer