Roivants mission is to systematically reduce the time, cost, & risk of delivering new medicines to market by accelerating the development of promising drug candidates to improve the lives of patients & their families. Since its inception in 2014 Roivant has achieved the following critical milestones in support of its vision: launched over 20 portfolio companies (Vants); 5 successful IPOs; $3B partnership with global pharma; pipeline of over 40 assets across various modalities & therapeutic areas; 8 successful phase 3 readouts since 2019. Building upon this track record of establishing a robust pipeline through in-licensing & acquisition of novel assets & technology platforms, Roivant is currently building new capabilities in drug discovery & expanding upon existing development disciplines to become the first large tech-enabled pharmaceutical company.
As the centralized engine for innovation & development the Roivant R&D team is responsible for: 1) discovery efforts focused on integrating computational & medicinal chemistry methods in order to establish R&D leadership positions in oncology, immunology & rare diseases; 2) working hand in hand with Business Development to establish the scientific rationale & initial development strategy for in-licensing opportunities; 3) providing tactical & strategic R&D support to stand up new portfolio companies (Vants) & advance development efforts across the portfolio.
Position Title: Director, Clinical Data Management
Position Location: New York, NY (location arrangements are flexible, however)
Manager Title: Head of Biometrics
Position Summary: The Director, Clinical Data Management will be responsible for day-to-day data management tasks for all studies conducted by Roivant Sciences and/or subsidiaries & collaborate with other functional areas such as clinical development, clinical operations, statistical programming, & biostatistics. This person will ensure the accuracy, consistency, completeness, & high quality of the clinical database. In addition, the incumbent will be responsible for the overall development, management, & administration of Data Management function at Roivant Sciences. The Director, Clinical Data Management will report to the VP, Biometrics & Data Management & will work closely with cross-functional teams on multiple clinical development programs. This position is a remote, work from home opportunity.
- Leads oversight of data management for outsourced clinical trials including project management, vendor management, coordination of internal reviews & data cleaning process, & approval of deliverables.
- Develops & maintains data management SOPs & policies as required to maintain overall quality & consistency of Data Management.
- Oversees CRO/Vendor activities to ensure GCP compliance, ensure all work is carried out in strict accordance with the relevant protocols, Standard Operating Procedures, & in compliance with Good Clinical Practices.
- Oversees data management activities to maintain consistency across trials/development projects: including Case Report Form (CRF) design & standards, Data Management Plans, CRF annotation & completion guidelines, edit check programs/specifications, data entry & query status tracking, & database closure.
- Oversees database design & production, ensuring that CROs, vendors & internal staff meet the highest quality standards per SOPs.
- Oversees the tracking of important study metrics such as data entry, source verification, & query resolution status.
- Performs supervisory duties as needed including but not limited to interviewing, hiring, training, intervention, discipline, & discharging of staff.
- Coaches & mentors staff including initiating & implementing appropriate staff development programs. Meets with staff on a routine basis to review goals & individual development plans.
- Ensures that staff levels are adequate in quality & quantity to meet the forecasted workload. Recommends changes if necessary & justifies them in accordance with company policy.
- Ensures that appropriate training programs are in place so that staff is adequately & properly trained for their job requirements.
- Ensures that all training files are up to date & complete in accordance with SOPs & ICH/GCP.
- Perform other related duties as assigned.
Skills, Qualifications, & Requirements:
- Minimum Bachelor degree in Science/Medical or Quantitative Science field MS/MA Preferred but not required.
- Minimum 10 years of data management experience in CRO, biotech, or pharmaceutical industry with at least 5 years management experience.
- Strategic leadership in a cross-functional team setting with extensive experience in an outsourced model, EDC databases, CDASH, medical terminology, medical coding dictionaries, & quality control processes.
- Proficient with Medidata Rave EDC and/or Oracle InForm.
- Working knowledge of SAS or SQL preferred.
- Knowledge of GCPs & regulatory agency guidelines.
- Strong leadership, interpersonal, organizational, & multi-tasking skills, & ability to collaborate & influence within cross-functional teams.
- Prior experience in oncology trials preferred but not required.