Marietta Toal
Senior Manager, Data Management @MacroGenics, Inc.
Signup · Get unlimited contacts
WORK HISTORY
Senior Manager, Data Management @MacroGenics, Inc.
Provides program management and vendor management of third-party organizations providing external support for oncology clinical trials for phase • Works with the VP, Data Management to provide departmental oversight, management, and mentoring activities for both permanent and contracted staff; • Provides oversight of CROs, IRT and EDC vendors to ensure DM and deliverables are complete to ensure successful completion of clinical studies; • Provides managerial and developmental support to DM staff encompassing experience from junior through principal data manager staff; • Manages vendor deliverables within timelines; to proactively identify issues that require escalation to ensure solution of issues arising; • Interacts with internal clinical study team to ensure all stakeholders’ needs are addressed. • Provide regular program updates to VP, Data Management, as appropriate • Establishes metrics to assess timeliness of database start up, study maintenance, and database locks; • Acts as author/reviewer for protocols, CCGs, data validation specifications, data management plans, SOPs, protocol deviation specifications, data reports, TLFs; • Oversees database build design from development through Production Go-Live, and migrations; • Ensures that data meet the highest levels of quality; • Monitors deliverables for periodic regulatory filings; • Provides budget information to VP, Data Management to ensure adequate resources for current and future clinical studies’ development. • Interacts with Product Development teams to assist in development of clinical/drug programs for the company • Collaborates with DM Operational staff to fine-tune departmental processes and procedures. • Experience with EDC databases Medidata RAVE, CDASH/SDTM standards, MedDRA, WhoDrug, JReview; • Ensures that data management processes and procedures meet GCPs, GCDMPs, ICH and FDA requirements; • Sets departmental goals for direct reports
EDUCATION
St. Norbert College
B.S., Biology
Creighton University
Biology, General
SKILLS
ABOUT MARIETTA TOAL
Certified Clinical Data Manager (CCDM) with over 36 years in the Clinical Research arena,…
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.