AKIN FASANMI
Sydney,NS
Summary
A Senior Clinical Data Manager with 10 years of experience providing strategic leadership in Clinical Drug development, Clinical Data Management, and project management. In addition, have 4 years of experience as a Data manager leading studies independently from initial study setup, data processing and study closeout activities. Experience as an electronic Medical record superuser. Experience with Direct Data Capture and mobile virtual systems in Decentralized clinical trials.Looking to bring these experiences and skills (both in technical, clinical and communicative areas) into a new implementation space.
Overview
10
10
years of professional experience
1
1
Certification
1
1
year of post-secondary education
Work History
Senior Clinical Data Manager
Aurum Institute
03.2022 - Current
- Provided clinical data management leadership within the study team to align on and drive data collection requirements for one or more complex clinical development proje
- Responsible for end to end clinical data management activities and serves as a primary point of contact for internal and external study team members
- Took a leadership role to gather content and integration requirements for EDC and close collaboration with partners supporting other data collection systems (eCOA, External Data, Safety Gateway). Enforced data standard conventions and quality expectations for clinical data per defined processes.
- Chaired Data Quality Review meetings with cross functional study team members to ensure on-going review of trial data currency , quality and completeness
- Represented Data Management on cross-functional project teams & submission Teams.
Senior Clinical Research Associate
PRA Health Sciences
07.2021 - 04.2022
- Carried out monitoring visits like SIV, IMV, COV from site selection to close out visits.
- Provided guidance and support clinical trial sites on clinical study execution.
- Acted as Clinical sites’ main point of contact, accountable for quality and delivery of sites from study initiation to close out of the trial.
- Ensured completeness of Investigator site files and the Trial Master file (TMF) for assigned studies.
- Implemented and monitored clinical trials to ensure that sponsor and investigator obligations are met and are compliant with applicable local regulatory requirements.
Contract Clinical Research Associate
Aerotek/IQVIA
12.2020 - 12.2021
- Performed site selection for potential clinical trials study sites.
- Updated all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including performing regular reviews of site-level data in clinical systems (e.g. CTMS, EDC, IVRS) and ensured timely and high-quality data entry compliance from sites.
- Provided project-level coordination and daily oversight of assigned clinical study tasks.
- Reviewed quality and Integrity of clinical trial data by on-site source verification.
- Supervised clinical data review on an on-going basis to ensure data quality.
Clinical Research Coordinator
Emory University School Of Medicine
09.2018 - 09.2020
- Performed clinical initiation activities. Like site staff training, checking the site documentation for correctness in line with the study protocol.
- Reviewed clinical trial subject's data and reconciled data between multiple sources and interphase with core study teams to schedule chart reviews and resolve problems or queries identified from monitoring visits
- Facilitated operational linkages within and among co-investigators, clinic directors, physicians, and other health professionals within the Hospital, specialist clinics, and medical professionals.
- Data cleaning and review of study data in preparation for database lock.
- Ensured studies were conducted in compliance with Good Clinical Practice and FDA regulations.
- Periodically audited clinical trial operations including laboratory procedures to ensure compliance with applicable regulations; provided leadership in identifying and implementing corrective actions/processes.
- Monitored IRB submissions and responded to requests and questions to facilitate study start-up and amendments.
- Utilized several Clinical Data Management systems like Redcap, MedidataRave, InForm, Oncore, Oracle clinical.
- Provided leadership and guidance in determining, recommending, and implementing data management processes.
- Participated in data safety management review (DSMB) review meetings.
- Coordinated data reconciliation meetings to harmonize reported severe adverse events (SAE) between the Medidata and Argus databases.
- Monitored the accuracy of study documents in the CTMS informed consent documents for specific protocols under the guidance of the responsible Principal Investigators.
Clinical Data Manager
Emory University School Of Medicine
08.2014 - 09.2018
- Provided CDM expertise for database set up, CDM design, and data cleaning to efficiently ensure high quality data.
- Executed data management plans for 3 studies and implemented EDC system testing for 4 study protocols.
- Verified data in the EDC for correctness, developed data collection, and verification systems.
- Created and maintained study data management documents (e.g. Data Management Plan, data validation plan, EDC system user’s guide, CRF.
- Resolved queries generated in the electronic Data Capture system (EDC) and resolved discrepancies between the EDC and Safety databases.
- Reviewed case report forms and audited for accuracy with source documents.
Education
Master of Arts - Organizational Management
Crandall University
Moncton, Canada 08.2023 - Current
Masters of Public Health - Public Health Informatics
Emory University
USA08.2021
Master of Science - Public Health
University of London
London07.2014
M.D. - Medical Degree
Ahmadu Bello University
Zaria, Nigeria06.2000
Skills
- Strong knowledge and familiarity of Data Management applications, EMRs and HMIS (EMR) like Redcap, EPIC, and CERNIER
- Leadership of Multi country cross-functional teams
- Member of the Data Governance Committee at Aurum Institute
- Proficient in the implementation of Direct Data Capture systems to sites
- Knowledge and application of advanced database functionality and Standard Operating procedures
- Experience in Clinical Informatics with a strong clinical information system background
- Understanding and experience in virtual mobile data implementation of electronic health records
- Understanding of general computer hardware, networking, and applications
- Skill and experience in IT project management and software implementation
- Strong communication and vendor management skills
- Working Independently
Certification
Society of Clinical Research Associates(SOCRA), Certified Clinical Research Professional.
Timeline
Master of Arts - Organizational Management
Crandall University
08.2023 - Current
Senior Clinical Data Manager
Aurum Institute
03.2022 - Current
Senior Clinical Research Associate
PRA Health Sciences
07.2021 - 04.2022
Contract Clinical Research Associate
Aerotek/IQVIA
12.2020 - 12.2021
Clinical Research Coordinator
Emory University School Of Medicine
09.2018 - 09.2020
Clinical Data Manager
Emory University School Of Medicine
08.2014 - 09.2018
Masters of Public Health - Public Health Informatics
Emory University
Master of Science - Public Health
University of London
M.D. - Medical Degree
Ahmadu Bello University
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