YINKA AIYELABOWO
Summary
Clinical project manager specializing in strategic oversight of clinical trials, with expertise in regulatory compliance and project management. Experience includes developing investigational protocols and leading cross-functional teams to achieve project milestones. Strong focus on quality reporting and enhancing communication among stakeholders.
Overview
18
18
years of professional experience
Work History
Clinical Project Manager
NESTLÉ HEALTH SCIENCE
12.2017 - Current
- Ensured study completion within timelines and budget while adhering to contract specifications for successful project delivery.
- Maintains and evaluates project progress by developing and maintaining timelines and budgets
- Managed vendor selection and oversight, including RFP process, negotiation, contracting, and service level management for vendors such as laboratories, CROs, CTM packaging, labeling, storage, data management, central IRB, and IVRS companies.
- Developed the Investigational Plan/Protocol and the Informed Consent Form (ICF) template and submitted to central Institutional Review Board (IRB).
- Maintain effective communication with vendors, project team, and investigative sites through oral and written correspondence to facilitate project alignment and issue resolution. Oversaw participant enrollment for clinical trials to ensure adherence to timelines. to meet timelines
- Ensure that protocol-specific training for Investigators, Study Coordinators, and other key study personnel is conducted and documented
- Plan, organize, prepare materials for and participate in investigator meetings, ad hoc scientific advisory board meetings, or Data Safety & Monitoring Boards (DSMB) meetings, as required
- Provide clinical data as needed for presentations, publications, and regulatory submissions
Clinical Research Associate III
PRA Health Science
08.2011 - 12.2017
- Conduct Pre-Study (Qualification), Site Initiation, Interim and Close-Out monitoring visits for multiple projects.
- Evaluate clinical data including Case Report Forms (CRF) and source documents, to ensure subject safety, investigator compliance, site adherence with the study drug protocol, FDA regulations, ICH Guidelines, Good Clinical Practice (GCP) and HIPAA.
- Review and follow-up on Adverse Events (AE), Severe Adverse Events (SAE) reports.
- Implemented strategies that enhanced site recruitment for a phase II study.
- Identified investigators and evaluated sites for phase II/III clinical studies.
- Performed source document verification and ensured the collection of credible data for phase II/III trials.
- Provide support and timely follow up for the implementation of clinical protocols, data collection systems, pre-post audits, quality assurance activities, and final reports.
- Ensured the maintenance of a complete regulatory binder and TMF according to the FDA/GCP guidelines.
Project Specialist II
Allon Therapeutics
01.2009 - 08.2011
- Coordinated quarterly payment initiation to study sites, ensuring timely financial support.
- Resupplied resources (diaries, assessments booklets, site binders, etc.) to sites to support study operations.
- Maintained, stored, and completed essential documents in TMF to ensure compliance.
- Oversaw the maintenance and distribution of internal team meeting minutes to the study team.
- Completed the submission of finalized trip reports and correspondence letters to the sponsor.
- Managed the sorting, archiving, and maintenance of the study-shared mailbox.
- Coordinated the distribution of the newsletter to site staff.
Education
B.A - Political Science
Hunter College
Clinical Research/GCP Training -
Allon Therapeutics
CITI GCP training -
Allon Therapeutics
Skills
- Clinical trial design
- Regulatory compliance
- Project management
- Trial master file and eClinical
- Interactive web response and IWRS
- Microsoft Project suite
- Excel and Word
- Outlook and PowerPoint
Relative Skills
- Microsoft platforms such as Excel, Word, Office, Outlook, and PowerPoint
- EDC systems: TrialMaster
- CTMS systems: eClinical
- IVRS/IWRS
Therapeutic Expertise
- Non-Small Cell Lung Cancer
- Ovarian Cancer
- Bipolar Disorder
- Parkinson Disease
- Hypertension
- HIV/AIDS
Timeline
Clinical Project Manager
NESTLÉ HEALTH SCIENCE
12.2017 - Current
Clinical Research Associate III
PRA Health Science
08.2011 - 12.2017
Project Specialist II
Allon Therapeutics
01.2009 - 08.2011
CITI GCP training -
Allon Therapeutics
Clinical Research/GCP Training -
Allon Therapeutics
B.A - Political Science
Hunter College