Otop Dike
@otopdike
Principal Clinical Data Manager driving end-to-end global trial data quality, inspection readiness, and high-performing CDM teams.
United StatesWhat I'm looking for
I’m a strategic, results-driven Principal Clinical Data Manager with over 13 years of progressive Clinical Data Management experience, including 6 years of leadership and oversight of global data management teams. I lead Phase I–IV, global multicenter clinical trials across Oncology, Infectious Diseases, Neuroscience, Ophthalmology, Cardiovascular, Respiratory, Rare Diseases, and Vaccines.
My value is full clinical data lifecycle ownership—from protocol review and CRF design through database build, edit check development, vendor oversight, data cleaning, SAE reconciliation, interim analysis, database lock, and regulatory submission readiness. I’m known for driving data quality and inspection readiness while ensuring operational excellence.
In my current role, I provide end-to-end strategic leadership for multiple global trials, chair data review and database lock readiness meetings, and implement risk-based data cleaning strategies to improve efficiency and data quality. I also oversee medical coding (MedDRA and WHO Drug dictionaries), manage external vendor data transfers, and lead SAE reconciliation with Pharmacovigilance to support compliance.
Previously, as a Senior/Lead Data Manager at Syneos Health and a Clinical Data Manager at Parexel, I managed 5–8 concurrent global studies, served as a primary Data Management contact for sponsors and cross-functional teams, and mentored junior CDMs through training and onboarding. I bring disciplined documentation, TMF readiness, and process improvement mindset grounded in ICH-GCP and FDA expectations.
Experience
Work history, roles, and key accomplishments
Lead Clinical Data Manager
Altru Bio
Mar 2022 - Present (4 years 1 month)
Led end-to-end data management for Phase II–III global trials in psychiatry, ophthalmology, and infectious diseases, overseeing protocol review through database lock and regulatory submission readiness. Directed CRF design with CDISC alignment, Medidata Rave build/UAT, risk-based data cleaning, SAE reconciliation, vendor transfers, and mentoring of junior CDMs.
Owned the full clinical data lifecycle for 5–8 concurrent Phase I–IV global studies across multiple therapeutic areas, serving as primary data management contact for sponsors and cross-functional teams. Directed CRF development, database configuration, edit check programming, UAT, discrepancy and query resolution, interim data cuts, and SAE reconciliation while supporting audits and inspections.
Managed clinical databases from study start-up through database lock for Phase I–III global trials, ensuring high data quality and on-time delivery. Partnered with Clinical Operations and Biostatistics to translate protocol requirements into analysis-ready data strategies, build CDISC-aligned CRFs with validation rules, and maintain audit-ready TMF documentation through inspections.
Senior Clinical Study Coordinator
Emory University Teaching Hospital
Jan 2012 - Jul 2013 (1 year 6 months)
Managed clinical databases from study start-up through final database lock, supporting data integrity, quality, and regulatory compliance across trial lifecycles. Designed and implemented CDISC-compliant CRFs and validation frameworks, led database UAT and discrepancy management, and coordinated interim analysis and coding/vender data reconciliation with TMF maintenance.
Education
Degrees, certifications, and relevant coursework
University of Calabar
Bachelor of Science, Biology
Earned a B.Sc. in Biology from the University of Calabar, graduating in December 1998.
Tech stack
Software and tools used professionally
Availability
Location
United StatesAuthorized to work in
Job categories
Skills
Interested in hiring Otop?
You can contact Otop and 90k+ other talented remote workers on Himalayas.
Message OtopFind your dream job
Sign up now and join over 100,000 remote workers who receive personalized job alerts, curated job matches, and more for free!
