At Roivant, we are passionate about discovering and developing new drugs to impact patients' lives. Since its inception in 2014, Roivant has launched over 20 portfolio companies (Vants), overseen 5 successful IPOs, established a $3B partnership with a global pharma, built a pipeline of over 40 assets across various modalities and therapeutic areas, and delivered 8 successful phase 3 readouts. Roivant is currently building new capabilities in drug discovery and expanding its existing development engine to become the world's leading tech-enabled pharmaceutical company.
As the centralized engine for innovation and development the Roivant R&D team is responsible for: 1) discovery efforts focused on integrating computational and medicinal chemistry methods in order to establish R&D leadership positions in oncology, immunology and rare diseases; 2) working hand in hand with Business Development to establish the scientific rationale and initial development strategy for in-licensing opportunities; 3) providing tactical and strategic R&D support to stand up new portfolio companies (Vants) and advance development efforts across the portfolio.
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 and collaborate with other functional areas such as clinical development, clinical operations, statistical programming, and biostatistics. This person will ensure the accuracy, consistency, completeness, and high quality of the clinical database. In addition, the incumbent will be responsible for the overall development, management, and administration of Data Management function at Roivant Sciences. The Director, Clinical Data Management will report to the VP, Biometrics and Data Management and 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 and data cleaning process, and approval of deliverables.
- Develops and maintains data management SOPs and policies as required to maintain overall quality and 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, and in compliance with Good Clinical Practices.
- Oversees data management activities to maintain consistency across trials/development projects: including Case Report Form (CRF) design and standards, Data Management Plans, CRF annotation and completion guidelines, edit check programs/specifications, data entry and query status tracking, and database closure.
- Oversees database design and production, ensuring that CROs, vendors and internal staff meet the highest quality standards per SOPs.
- Oversees the tracking of important study metrics such as data entry, source verification, and query resolution status.
- Performs supervisory duties as needed including but not limited to interviewing, hiring, training, intervention, discipline, and discharging of staff.
- Coaches and mentors staff including initiating and implementing appropriate staff development programs. Meets with staff on a routine basis to review goals and individual development plans.
- Ensures that staff levels are adequate in quality and quantity to meet the forecasted workload. Recommends changes if necessary and justifies them in accordance with company policy.
- Ensures that appropriate training programs are in place so that staff is adequately and properly trained for their job requirements.
- Ensures that all training files are up to date and complete in accordance with SOPs and ICH/GCP.
- Perform other related duties as assigned.
Skills, Qualifications, and 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, and quality control processes.
- Proficient with Medidata Rave EDC and/or Oracle InForm.
- Working knowledge of SAS or SQL preferred.
- Knowledge of GCPs and regulatory agency guidelines.
- Strong leadership, interpersonal, organizational, and multi-tasking skills, and ability to collaborate and influence within cross-functional teams.
- Prior experience in oncology trials preferred but not required.
Roivant Sciences provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.