Karin Graefe

About Karin Graefe

Clinical Data Management Leader with extensive experience in oversight of Clinical Data…

Experience

1. Sr Manager, Clinical Data Management (through 10 2024)

   Seres Therapeutics

   Apr 2021 — Present · Cambridge, MA, US

   Managed and supported multiple, complex clinical trials in various stages. Led and supported the design and implementation of clinical data management processes with vendors, ensuring completeness, accuracy, quality and consistency of clinical trial data. • Provided vendor management oversight ensuring data management activities for clinical trials within assigned research programs were completed in a timely and accurate manner. Oversaw development of edit check specifications, CRF Completion Guidelines, Data Management Plans, Data Review Guidelines, SAE Reconciliation Plan, and project-specific charters with input from cross-functional study team. Participated in the review of clinical data, analysis tables, listings, figures, and patient profiles for data consistency, quality and accuracy.• Communicated and escalated study level issues, including enhanced processes, timelines, resourcing, and vendor personnel performance, etc. Reviewed budgets, contracts and change orders to ensure departmental and corporate objectives were met. • As Lead Data Management SME for regulatory inspection interviews, supported internal study team in preparation and readiness for BIMO and investigational site regulatory inspections. Staged documents in inspection back room for submission to inspectors.• Received SuperNova Award in Jan, 2024, an honor for an employee whose trailblazing spirit, perseverance, innovation, and achievements have propelled Seres to new heights, adding exceptional value and impact to the organization. Award recognized the integrity of the SER-155 datasets, command of EDC systems, and perseverance through difficult situations with grace, patience, and compassion for people.• Received Establishing Award in Fall, 2022, in recognition of substantial contributions made to BLA submission for SER-109, a first of its kind, oral microbiome therapeutic, VOWST™, which FDA approved in April, 2023 for treatment of recurrent c.difficile infections.

Education

• Wheaton College (MA)

  B.A.