Mary Ademola
Fulshear,TX
Summary
Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.
Overview
10
10
years of professional experience
Work History
Senior Clinical Data Coordinator
ICON formerly PRA Health Science
10.2020 - Current
- Reviews Clinical Protocol / amendments
- Coordinate with DB developers/programmers for effective and timely database design
- Manages clinical data review activities that contribute to delivery of analyzable database
- Represents data management and effectively communicate requirements, strategy, timelines, and deliverables at meetings with external vendors and internal cross functional team meetings
- Manage queries and trends to ensure data completeness and integrity
- Generate tables and listings for data cleaning through SAS
- Reviews and maintains Data Management Plans
- Performs quality control checks of eCRF pages
- Generates and reviews coding reports for consistency and accuracy according to MedDRA and WHODRUG dictionaries
- Skilled at working independently and collaboratively in team environment.
- Managed time efficiently in order to complete all tasks within deadlines.
- Documentation and filing of study documentations in eTMF
- Performs Cross Functional Data Review and brings issues identified to resolutions
- Documents minute of meeting during cross functional data review meetings and CTSE meetings
- Leads SAE data reconciliation of cumulative reports from Safety Database and data management database
- Ensures Protocol Deviations are entered for visit assessments performed outside protocol window
- Runs missing page report and ensures data entries on protocol required pages
- Runs metrics report prior to CTSE meetings for discussions
- Participates in site training and support for query resolutions
- Takes necessary actions to ensure data management deliverables are met
- Participates in data management meetings with sponsor as required
- Collaborates with clinical team to support milestone achievements
- Contributes to achievement of goals through personal effort and influence over others in department
- Performs cross panel check between AE forms and Con Med forms, Medical History forms and Con Med forms
- Performs data management activities for interim analysis lock for safety and efficacy analysis
- Performs quality control checks of Study Service Request documents for GCP and FDA inspection readiness
- Attends data management training for data management processes and systems
- Promotes positive and professional work environment
- Ensures compliance with appropriate sponsor SOPs
- Mentors and trains other team members.
- Participated in quality assurance reviews to verify accuracy and reliability of data.
- Demonstrated respect, friendliness and willingness to help wherever needed.
- Worked with programming to coordinate Study Data Tabulation Model maps.
- Assisted with database upgrades and migrations by performing user acceptance testing.
Clinical Data Manager
SK Life Science
03.2016 - 06.2020
- Performed protocol and CRF review for study start-up.
- Developed and Maintained Data Management Plans.
- Skilled at working independently and collaboratively in team environment.
- Worked well in team setting, providing support and guidance.
- Oversaw reconciliation of all third-party data with EDC database
- Delegate and collaborate with data managers on database cleaning process.
- Monitored discrepancy management to ensure appropriate quality of data by regular checks during study conduct.
- Participates in data management activities for interim analysis according to protocol for safety and efficacy analysis.
- Manual review of clinical study data
- Served as primary DM contact for multiple projects
- Conducts data management meetings
- Validated data entry screens before edit check programming.
- Participated in quality assurance reviews to verify accuracy and reliability of data.
- Assisted with database upgrades and migrations by performing user acceptance testing.
- Scheduled and contributed to study team meetings
- Mentored and trained multiple clinical data coordinators for successful study startup, maintenance, and closeout
- Performed external data reconciliation
- Reviewed Protocol Deviation Reports
- Performed side-by-side reconciliation between data management database and safety database for SAE reconciliation to ensure consistency and accuracy
- Performed coding review by running coding reports to make sure all verbatim terms are coded according to MedDRA and WHO Drug dictionaries
- Created and reviewed data transfer specification
- Reviewed and summarized metric reports / study status reports sent by CRO and presented it to in-house DMs for their reviews and comments
- Archived all final study documentations which included final protocol, annotated CRF, DMP components and all conventions in eTMF using Veeva Vault
- Oversaw activities of CRO data managers from study start-up to database lock
- Performed interim analysis according to protocol for safety and efficacy analysis
- Used RECIST criteria for oncology studies
- Led and performed data lock tasks.
Clinical Data Manager II
HealthCore Inc
12.2013 - 01.2016
- Performed all study build, conduct and maintenance, and database lock of assigned studies from Phase I to III
- Reviewed all study documentations including protocol, DMP and SOP to gain understanding and knowledge of studies accurately.
- Assisted with database upgrades and migrations by performing user acceptance testing.
- Participated in study team meetings and contributed to activities to improve and maintain quality and effectiveness of data management processes within function.
- Query review, data validation and discrepancy management.
- Participates in data management activities for interim analysis according to protocol for safety and efficacy analysis.
- Performed manual data review and brought discrepancies to resolutions.
- Performed SAE reconciliation between EDC and Argos database.
- Performed cross panel check between AE and CM forms.
- Reviewed coding of event terms and CM forms for consistencies.
- Proven ability to learn quickly and adapt to new situations.
- Worked with programming to coordinate Study Data Tabulation Model maps.
Education
Pharmacy Technician Certification -
Udemy
Bachelor of Arts -
Olabisi Onabanjo University
Nigeria11.2006
Skills
- Strong written and verbal communication skill
- Digital Literacy - Proficient with Electronic Data Capture (EDC) systems, Microsoft Office
- Compliance with Good Clinical Practice (GCP), ICH Guidelines and all applicable laws
- Data oversight
- Discrepancy management
- Database finalization
- SOP compliance
- Solution deployment
- Teamwork and Collaboration
Timeline
Senior Clinical Data Coordinator
ICON formerly PRA Health Science
10.2020 - Current
Clinical Data Manager
SK Life Science
03.2016 - 06.2020
Clinical Data Manager II
HealthCore Inc
12.2013 - 01.2016
Pharmacy Technician Certification -
Udemy
Bachelor of Arts -
Olabisi Onabanjo University
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