Improving quality-of-life through innovations in urology.
Urovant Sciences (Nasdaq: UROV) is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions. Urovant is a company with an entrepreneurial focus on improving the way providers and their patients confront urologic diseases that are difficult to treat.
Every employee at Urovant plays an integral role to our success. We are ambitious in our approach to improving outcomes for the patients and healthcare providers we serve. Our fast-paced environment rewards strategic decision-making and collaboration, giving team members opportunities to grow beyond their expertise.
Urovant’s lead product candidate, vibegron, an oral, once-daily small molecule beta-3 agonist being evaluated for overactive bladder (OAB). In addition to OAB, vibegron is being evaluated for two additional potential indications: the treatment of OAB in men with benign prostatic hyperplasia (BPH) and the treatment of abdominal pain associated with irritable bowel syndrome (IBS).
Urovant’s second investigational product candidate, URO-902, is a novel gene therapy for patients with overactive bladder symptoms who have failed oral pharmacologic therapy.
The Associate Director, Data Management will serve as the as the lead clinical data manager for clinical (Phase I-IV) trials as assigned and responsible for providing input to protocols, design and review case reports forms, provide input to database development and perform all data management related activities.
This person is expected to ensure that the clinical data management elements are in line with the overall deliverables and to ensure adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements.
The position is based at Urovant’s site in Durham, NC and reports to the Senior Director, Biostatistics, Programming & Data Management.
- Perform and provide oversight of data management study activities and timelines during study start up, study conduct, database lock, and documentation archival.
- Represent Data Management for assigned studies within multidisciplinary project teams.
- Conduct oversight of Data Management CROs by ensuring data management documents and tasks are completed and delivered in accordance with timelines and data quality standards.
- Drive development of study related Data Management deliverables (eg, eCRFs, DTAs, etc.).
- Participate in the implementation of clinical systems (e.g., EDC, IRT, eCOA).
- Monitor supplier performance to ensure timelines and data quality standards are met.
- Develop Standard CRF Library and ensure CDISC standards, where applicable.
- Cross-functional process improvement projects.
- Manage the progress of data management related activities on clinical studies and ensure adherence to appropriate plans and processes, internal operating procedures, intended timelines and budget.
- Lead or participate in data management CRO and technology evaluations, qualifications, selections and implementations.
Education and Experience:
- Bachelor’s degree required.
- 10 plus years data management experience in the Pharmaceutical, Biotechnology, or Contract Research Industry.
- Ability to clearly communicate processes and standards with management and team members.
- Hands-on knowledge of data management activities, clinical database design, specifically electronic data capture from various vendors.
- Knowledge of SDTM models and experience transforming raw data into those standards.
Essential Skills and Abilities:
- Experience leading data management related projects with cross-functional stakeholders; strong knowledge of CDM processes and key documents (e.g., CRF development, database set-up/lock activities, DMP, etc.).
- Experience with EDC and other system used in clinical studies (e.g., RTSM, eCOA).
- Managing Suppliers at a Study Level.
- Knowledge of Good Clinical Practice (GCP), ICH, and Regulatory requirements.
- Understanding of Inspection Readiness/Regulatory considerations for their role, and the capability to represent the organization during an inspection.
- Effective and clear communication style, both written and verbal.
- Effective Project Management skill.
- Problem solver, researches and presents solutions to issues.
- Flexible, team-oriented.
- Professional demeanor.
- Contract review and negotiation.
- Some travel may be required.