Data Manager

About Us

Sagimet is a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors that are designed to target dysfunctional metabolic pathways in diseases resulting from the overproduction of the fatty acid, palmitate. Sagimet’s lead drug candidate, denifanstat, is an oral, once-daily pill and selective FASN inhibitor in development for the treatment of NASH, for which there are no treatments currently approved in the United States or Europe. FASCINATE-2, a Phase 2b clinical trial of denifanstat in NASH with liver biopsy-based primary endpoints, was successfully completed with positive results. For additional information about Sagimet, please visit www.sagimet.com.

Job Description: Data Manager

The Clinical Data Manager will be responsible for daily data management tasks for all phases of clinical trials including CRO/vendor oversight and support other functional areas such as clinical operations, statistical programming, and biostatistics. The Data Manager will ensure the accuracy, consistency, completeness, and high quality of the clinical database. The role will be to work closely with cross-functional teams on the clinical development program, health authority submissions, presentations, and publications across internal and external stakeholders.

Key Data Manager Responsibilities:

• Lead clinical data management oversight of outsourced clinical trials for Sagimet clinical trials including project management, vendor management, coordination of internal reviews, and approval of day-to-day data management deliverables.
• Set up data management vendors as required, including review of RFPs, reviewing, and negotiating data management budgets and contracts.
• Oversight of all DM plans and activities e.g. ECRF’s CCG’s edit checks etc.
• Liaising with study management CRO to ensure site training and timely initiation.
• Provide direction and guidance to team members, including consultants and vendors, as well as other functional groups in Data Management area, to achieve study goals and milestones.
• Oversee database design and post-production updates, ensuring that CROs, vendors, and internal staff meet the highest quality standards per the latest industry standard and regulatory authority requirements.
• Responsible for sponsor user acceptance testing, including documenting findings and resolving with CRO
• Oversee data management activities including reviewing data management documents, data flow metrics, and driving data snapshot/closeout activities.
• Proactively identifies risks and execute risk mitigation strategies; Maintains timely communication with both upper management and cross-functional teams.
• Oversees CRO/Vendor activities to ensure GCP compliance, quality expectations are met, and timelines are adhered to.
• Contribute to program deliverable timeline creation and project re-forecasting.
• Support data management activities for regulatory submissions
• Performs additional duties as assigned.

 Qualifications:

• BS degree required (in life science or related field preferred) with minimum of 4 years of hands-on data management/CDM experience in CRO, biotech or pharmaceutical industry
• Experience leading clinical studies from study start up to database lock and managing multiple programs, and/or multiple studies within a program
• Strong vendor oversight experience
• Experience managing and collaborating with multiple external data providers such as ePRO, central lab, specialty lab and central readers
• Experience working with eTMF systems and inspection readiness activities
• Understanding the principles of clinical research, ICH GCP (Good Clinical Practice), 21 CFR part 11, GCDMP (Good Clinical Data Management Practices) and related regulatory requirements
• Expertise with CDISC standards, including CDASH and SDTM; Working knowledge of SAS or SQL preferred
• Proficiency with Medidata Rave EDC, Clinical Data Repositories and Visualization software
• Proficient in Microsoft Word, PowerPoint, MS Project, Outlook and Sharepoint
• Ability to use a combination of Electronic Data Capture (EDC) systems and/or other internal or commercial software tools and proven ability to learn and apply new software quickly as projects require
• Experience in MASH/NASH trials preferred
• Regulatory submission, audit experience preferred
• Ability to work well in a team environment both as a leader and a contributor
• Excellent communication skills (written and oral) across all organizational levels
• Collaborative, respectful, agile and transparent work style