Senior Manager, Clinical Data Management
Epizyme, Inc. is a fully integrated commercial-stage biopharmaceutical company committed to its mission of rewriting treatment for cancer and other serious diseases through novel epigenetic medicines. In addition to an active research and discovery pipeline, Epizyme received U.S. FDA approval for the product, TAZVERIK™ (tazemetostat), for the treatment of patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma who are not eligible for complete resection. This indication was approved under accelerated approval based on overall response rate and duration of response. TAZVERIK™ also recently received accelerated approval by the U.S. Food and Drug Administration (FDA) for two distinct follicular lymphoma (FL) indications: 1) adult patients with relapsed or refractory FL whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies, and 2) adult patients with relapsed or refractory FL who have no satisfactory alternative treatment options.
Continued approval for these indications is contingent upon verification and description of clinical benefit in an ongoing confirmatory trials. The company is also exploring the treatment potential of tazemetostat in investigational clinical trials in other solid tumors and hematological malignancies, as a monotherapy and combination therapy in both relapsed and front-line disease settings. By focusing on the genetic drivers of disease, Epizyme seeks to match medicines with the patients who need them. For more information, visit www.epizyme.com.
Epizyme has assembled a world-class team with a passion for scientific innovation and a commitment to developing novel epigenetic therapies. Join a dynamic, diverse and fun work environment consistent with Epizyme’s cultural attributes for success: camaraderie, collaboration, disciplined, innovative, openness, patient-focused and resilient.
The Senior Manager, Clinical Data Management will lead and contribute to data management activities in support of Epizyme studies across all stages of clinical drug development.
This position reports to the Head of Clinical Data Management.
Summary of Key Responsibilities
- Contribute to data management activities as a lead study data manager in support of clinical studies
- Lead database build activities including leading cross-functional review of eCRF content, review of edit check specifications, and perform user acceptance testing
- Monitor data collection, coding, and cleaning by vendors through tracking of study metrics and targeted data reviews
- Oversight of database lock activities and ultimate archiving of study data
- Collaborate with internal and external partners
- Establish cross-functional internal data review plans, coordinate data cuts/transfers, and conduct data reviews
- Review CRO data management plans, CRF completion guidelines, external data transfer specifications and other study documentation
- Contribute to development and implementation of department workflows and infrastructure strategy
- Represent data management and effectively communicate requirements, strategy, timelines and deliverables at internal cross-functional team meetings and meetings with external vendors
- Participate in the drafting and/or review of timelines consistent with company goals and ensure all deliverables and milestones are met
- Review clinical protocols/amendments, clinical study reports, statistical analysis plans, etc.
- Support GCP inspection readiness
Education & Requirements:
- BS/BA in scientific discipline
- At least 7 years related experience in a pharmaceutical/biotech company
- Experience working in clinical drug development through Phase 3 in an outsourced CRO model
- Expert knowledge of eClinical processes, efficient design/build of an EDC data management system and other Clinical Trial/Data Management Systems
- Knowledge and understanding of regulations and industry/adopted data standards such as CDISC, SDTM, and CDASH
- Experience working with Oracle InForm, Medidata Rave or other major EDC systems
- Experience using standardized medical terminology, including MedDRA and WHODrug
- Experience working with MSOffice Suite (Excel, Word, PowerPoint)
- Excellent written and oral communications skills
- Highly motivated and flexible, with excellent organizational and time management skills
- Ability to work independently and as part of a multi-disciplinary team
- Understanding of ICH GCP as well as general knowledge of industry practices and standards
- Knowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11
Epizyme, Inc. is a vibrant, entrepreneurial EEO employer committed to a diverse and dynamic workplace.