YINKA AIYELABOWO
NESTLÉ HEALTH SCIENCE
Hollis,USA
17
years of professional experience
15 years of management experience. Known to produce quality reports. Identified as a top performing Clinical Project Manager. Experience working in phases I-III clinical trials. Excellent interpersonal skills. Can work easily under pressure
Work History
Clinical Project Manager
8 Years 6 Months- Assisted with the development of the Investigational Plan/Protocol and the Informed Consent Form (ICF) template and submitted to central Institutional Review Board (IRB) submissions.
- Maintains and evaluates project progress by developing and maintaining timelines and budgets
- Manage study vendor selection and oversight, including the Request for Proposal (RFP) process, negotiation and contracting, and service level management of vendors such as laboratories, Contract Research Organization (CRO), clinical trial material (CTM) packaging, labeling, and storage, data management, central IRB, Interactive Voice Response System (IVRS) companies, or others.
- Managed vendor selection and oversight, including RFP process, negotiation, contracting, and service level management for laboratories, CROs, CTM packaging, data management, and other vendors.
- Obtain required legal, ethical and technical agreements with sites and vendors participating in studies
- Develop case report forms (CRFs) and other study tools for implementation and tracking of study activities
- Ensured protocol-specific training for investigators, study coordinators, and key study personnel was conducted and documented.
- Maintained effective communication with vendors, project team, and investigative sites to facilitate trial enrollment and adherence to timelines.
- 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
Clinical Research Associate III
6 Years 4 Months- 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.
- Implemented strategies that enhanced site recruitment for phase II study.
- Conduct Pre-Study (Qualification), Site Initiation, Interim and Close-Out monitoring visits for multiple projects.
- Performed source document verification and ensured the collection of credible data for phase II/III trials.
- Manage site TMF contents and work with sites to ensure communication requirements between site and IRB are adhered to.
- Provide support and timely follow-up for the implementation of clinical protocols, data collection systems, pre-post audits, quality assurance activities, and final reports.
- Assured proper delegation of authority and trained site staff on study-related processes.
- Assured the proper delegation of authority, provided study related trainings to site staffs.
- Ensured the maintenance of a complete regulatory binder and TMF according to the FDA/GCP guidelines.
Project Specialist II
2 Years 7 Months- Ensured the maintenance, storage, and completion of the essential documents in the TMF.
- Managed the distribution of the newsletter to site staff.
- Coordinated the resupply of resources (diaries, assessments booklets, site binders, etc.) to sites.
- Documented and shared internal team meeting minutes with the study team.
- Prepared and submitted finalized trip reports and correspondence letters to the sponsor.
- Organized, archived, and maintained the study-shared mailbox.
- Processed quarterly payments to study sites.
Education
B.A. - Political Science
- Clinical Research/GCP Training
- CITI GCP training
Skills
Clinical trial management
Site monitoring
Patient recruitment
Regulatory compliance
TrialMaster EDC
eClinical CTMS
IVRS IWRS
Microsoft Office
THERAPEUTIC EXPERTISE
- Oncology: Non-Small Cell Lung Cancer and Ovarian Cancer
- CNS: Bipolar Disorder, Parkinson Disease
- Cardiovascular: Hypertension
- Infectious Disease: HIV/AIDS
Timeline
Clinical Project Manager
NESTLÉ HEALTH SCIENCE
01.2018 - CurrentRead More
Clinical Research Associate III
PRA Health Science
09.2011 - 01.2018Read More
Project Specialist II
Allon Therapeutics
02.2009 - 09.2011Read More
from CITI GCP training
Read More
Hunter College
B.A. from Political Science
Read More
Allon Therapeutics
from Clinical Research/GCP Training
Read More