Sonja Coull
Associate Director, Clinical Data Science (Portfolio Functional Director) at ICON plc
- Role
- Associate Director, Clinical Data Science (Portfolio Functional Director) at ICON plc
- Location
- Clayton, NC, US
- LinkedIn followers
- 500 followers
About Sonja Coull
Six Sigma Green Belt trained Account Manager/Data Operations Director/Project Management Director offering 30+ years of pharmaceutical/CRO experience and 25+ years of management experience supporting Phase I-IV clinical and device trials, including multiple regulatory submissions. Coached/mentored project team members, direct reports, and colleagues on various protocol execution and/or management/leadership activities; including cross-functional global oversight/collaboration on an asset/program of studies for data management, statistics, programming and medical writing. Supported VP of Data Operations business unit with financial review of margin and time per task data. Published article in International Journal of Medical Engineering and Informatics. Support DM department as an SME for ICON Digital Platform and Cell-Gene Therapy.Core competencies include: RFPs, BDMs, proposal text, budget review; Vendor management/oversight; Quality review; Timeline oriented, planning for successful outcomes; Change agent; Medical coding using MedDRA/WHODrug; Global team organization; Project team conflict resolution; CSR, TLF, narrative review; Protocol/amendment review/development; Presentations deliveredTherapeutic Areas: Fibrotic Diseases, Immunology, Oncology, Rheumatoid Arthritis, Hyperlipidemia, Cardiovascular, Dermatology, Respiratory and Allergy, Osteoporosis, Infectious Diseases, Osteoarthritis, Diabetes, Obesity Technical Skills: DataLabs; TrialStat Clinical Analytics; Acceliant, co-validation coordinator; OC RDC; Medidata RAVE; SAS, former Statistical Programmer; Inform; ClinPlus; Data entry system developer; Oracle; Merck CTS; Writing/executing test scripts/plans; SQL; Documentum; MS Office; Adobe
Experience
Associate Director, Clinical Data Science (Portfolio Functional Director)
Jul 2021 — Present · Raleigh, NC, US
Education
Rochester Institute of Technology
BS, Applied Mathematics
1989 — 1993
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