Kinevant Sciences, a wholly-owned subsidiary of Roivant, is focused on developing new therapies for rare auto-immune diseases, initially targeting sarcoidosis with an anti-GM-CSF monoclonal antibody (namilumab). The Company has recently initiated a Ph 2 clinical trial in pulmonary sarcoidosis. Sarcoidosis is a multi-organ autoimmune disease with poor treatment options that affects up to 200,000 people in the U.S. The long-term vision for Kinevant is to successfully develop and commercialize namilumab for sarcoidosis and potentially other inflammatory orphan diseases, as well as in-license other promising drug candidates for orphan autoimmune and inflammatory diseases.
Roivant’s mission is to systematically reduce the time, cost, and risk of delivering new medicines to market by accelerating the development of promising drug candidates to improve the lives of patients and 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); 6 FDA approved medicines; 5 successful IPOs; >$8B in global pharma deals and partnerships; pipeline of over 40 assets across various modalities and therapeutic areas; 8 consecutive positive phase 3 readouts since 2019. Building upon this track record of establishing a robust pipeline through in-licensing and acquisition of novel assets and technology platforms, Roivant is currently building new capabilities in drug discovery and expanding upon existing development disciplines to become the first large tech-enabled pharmaceutical company.
Position Location: Remote (location arrangements are flexible)
The Director, Clinical Data Management will take the data management lead on outsourced Phase I/II/III studies. Since the studies are outsourced, the individual will provide: vendor management oversight, review of DMPs, CRFs, DVS, perform UAT, etc. The individual must be an experienced Data Manager who is able to work independently and cross functionally. This individual must be self-motivated and collaborative amongst internal stakeholders as well as external and CRO partners as appropriate.
- Responsible for assessing in house data management needs and driving the selection and implementation of any in-house data management solutions including developing policies and procedures
- Responsible for clinical data management activities for outsourced studies
- Ensures data management activities for clinical trials within assigned research program(s) are completed in a timely and accurate manner
- Develops proposal requests to service providers; evaluates and approves service level agreements
- Oversees service providers to perform core data management functions including IWR/IVRS, CRF, edit check and CRF completion guidelines development, user acceptance testing, data cleaning, reviewing listings, and database locking procedures
- Works collaboratively with Biostatistics and Programming during data integration leading up to a regulatory filing
- Establish inter- and intradepartmental processes to improve the efficiency and quality of data processing
- Leads and manages DM tasks outsourced to external vendors and ensures that milestones, deliverables, quality and timelines are met within budget and in accordance with regulatory requirements.
- Develops positive partnerships with CROs and ensure a high standard of deliverables are maintained.
- Serves as the DM focal point on assigned studies for all local interfaces and preserves a fluent workflow with the other interfacing departments and local procedures and processes.
- Prepares and maintains timelines for the assigned studies, and communicates to management any issues so that appropriate actions can be taken.
- Prepares status reports and updates for data management as required
- Collects and monitors study metrics.
- Attends investigators’ meetings as appropriate; gives input into the presentations that involve relevant data management topics; oversees presentations delivered by service providers
- Approves data management plans for completeness and accuracy of required documentation according to SOP.
- Oversees collection, review and archiving of the DMP and other pertinent documents for all assigned studies.
- Oversees and performs UAT on CDMS components as needed.
- Provides input into CDMS requirements, assuring protocol requirements are met.
- Supports validation efforts to minimize the company’s exposure to regulatory risk by validating all electronic data streams and systems in support of organizational objectives
Skills, Qualifications, and Requirements
- BS Life Sciences or Computer Science
- 8-10 years of data management experience in a clinical research setting
- Strong working knowledge and prior experience directly managing/overseeing service providers and CRO’s is required
- Prior experience managing clinical data for multiple studies at one time
- Experience with computerized clinical data management systems is required
- Knowledge of SAS and database programming
- Systems integration experience
- Understanding of CDASH and CDISC standards
- Ability to work independently and collaboratively in a fast-paced, matrixed team environment consisting of internal and external team members
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines