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Work Background
Senior Clinical Research Associate
Panthera BiopartnersSenior Clinical Research Associate
Jan. 2024 - Jun. 2024London, England, United KingdomOn-site CRA responsible for site management of all active and historical studies. - Provided oversight of the Site Compliance Specialist team, supporting daily tasks such as ISF and source data maintenance, EDC query resolution, and study vendor management. -Led the collation and closure of issues from past CRA visits and monitoring letters. - Collaborated cross-functionally with the clinical, patient coordinator, and lab teams to ensure high-quality study conduct aligned with ICH-GCP and Sponsor/CRO expectations. - Contributed to all study phases including start-up, maintenance, close-out, and archiving. - Managed communications with internal and external stakeholders including CRAs, Project Management, Quality Assurance, Medical Director, and the CEO. - Oversaw quality systems by tracking and resolving Quality Issues (QIs), preparing for audits, and mentoring and developing site staff. - Supported PI oversight and Sponsor/CRO visits. - Regularly developed and presented site performance metrics and study updates to the Senior Leadership Team (SLT), addressing progress, ongoing issues, and timelines for resolution.
Clinical Research Consultant
RhoClinical Research Consultant
Nov. 2022 - Dec. 2023Various clinical monitoring, project and stakeholder management activities, including study start-up (writing and adapting ICFs & other supporting documents, ethics and regulatory submissions, budget & contract negotiations), feasibility, SIVs, IMVs and COVs. Highly proficient with IRAS and CPMS/iCT submissions.
Clinical Research Consultant
FreelanceClinical Research Consultant
Jun. 2021United KingdomExperienced Clinical Research Consultant supporting end-to-end delivery of commercial clinical trials for leading biopharmaceutical clients, including Syneos Health, Panthera Bio-Partners, Rho, and Allucent. Skilled in onsite and remote monitoring, regulatory submissions, project management, feasibility, and contract negotiations. Leads initiatives to enhance trial performance, patient enrolment, and site relationships. Offers regulatory input across key stages of clinical research—from site feasibility and contract localisation to ICF adaptation, MHRA/HRA combined submissions, and budget negotiations. Familiar with life sciences content management principles and systems such as Veeva Vault, ensuring compliant handling of regulated documents and streamlined collaboration across global teams. Applies a strong understanding of GxP, CSV (Computer Systems Validation), and inspection readiness to support high-quality trial execution. Also oversees research staff resourcing and development, creating training programs focused on regulatory greenlight, data quality, TMF/site file management, and study amendments. 👇 Scroll down for more on key projects and client work.
Senior Clinical Research Associate
Pharm-Olam, LLCSenior Clinical Research Associate
Jun. 2021 - May. 2022Provided clinical monitoring services for a major COVID-19, MHRA-approved vaccine study.
Clinical Research Associate II
Syneos HealthClinical Research Associate II
Sep. 2018 - May. 2021
In-House CRA/ Associate Site Manager (Real World Evidence)
IQVIAIn-House CRA/ Associate Site Manager (Real World Evidence)
Oct. 2017 - Jul. 2018Reading, England, United Kingdom
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