Organizational Overview:Immunovant is a clinical-stage biopharmaceutical company with a company vision focused on enabling normal lives for patients with autoimmune diseases. Our lead asset, IMVT-1401, is a novel, fully-human, anti-FcRn monoclonal antibody in clinical development for multiple indications, delivered as a subcutaneous injection for the treatment of autoimmune diseases mediated by pathogenic IgG antibodies. Immunovant is committed to developing innovative therapies that not only treat the symptoms but modify the course of autoimmune diseases, while restoring hope and health to patients with autoimmune disease by developing and delivering high-value restorative therapies that enable them to live normal lives.
The Senior Clinical Data Manager will be responsible for the day-to-day data management tasks within our clinical studies. Key duties are study set up, handling/oversite of data cleaning, managing third party data, and close-out responsibilities. This role works closely with the CRO Data Managers to ensure on-time seamless delivery of quality Data Management deliverables. This position leads all data management tasks independently to ensure that studies (phases 1-3) are properly designed, run, presented, and reported.
- Follow SOPs, and study specific procedures for the implementation of tasks during a study
- Actively manage CRO Data Management teams to ensure project objectives are met withing agreed timelines.
- Recognize potential Sponsor/CRO performance gaps and escalate them effectively for resolution
- Ensure the efficient implantation of standard metrics and status reporting for the study. Provide internal status updates/summarized metric reports.
- Support project management of activities
- Identify potential data issues and data trends, define resolutions, checks, contingency plans, and escalation to the Head of Data Management
- Lead regular status meetings and ensure relevant actions and minutes are correctly recorded and followed up
- Lead and participate in the ongoing review of all data generated from the clinical study including central and local lab data (working understanding of assorted lab tests and concepts regarding units and ranges to effectively clean the data), all other external data vendors, and if needed coding
- Lead and participate in the ongoing review of edit checks/listings for quality, content, format and output
- Responsible for ensuring that clinical data is validated according to study requirements and are ready for interim and final deliverables by providing clean and consistent data
- Bachelor’s degree or equivalent in a scientific field and/or appropriate experience
- Five (5-7) years of Data Management experience
- Relevant Clinical Data Management experience (thorough knowledge of data review/cleaning process)
- Extensive experience with cross functional collaborations and the ability to comfortably present and lead teams
- Biotech/pharma with CRO experience a plus
- Worked throughout study phases 1-4
- Skilled on a range of computer systems/tools, including Microsoft Office
- Knowledge of clinical trial databases (EDCs)
- Accountable and proactive
- Excellent accuracy and attention to detail
- Capable of managing competing priorities in a fast moving, changeable environment
- Capable of handling stressful situations and deadlines
- Capable of managing multiple studies at once
- Submission experience
- Remote position
- Dynamic, interactive, fast-paced and entrepreneurial environment
- May require up to 20% travel