Clinical Operations Trial
Resume:
Kehinde Adetoro
Address: *** ***** **, ********* **, 07202, USA.
Summary
Seasoned Senior Clinical Trial Management professional with over a decade of experience in the pharmaceutical sector, specializing in Clinical Operations and Drug Development. Highly proficient in Clinical Trial Management, Study Management, Vendor Management, Subject Recruitment, Site Oversight, and Financial Management, including accruals, invoice approvals, and bid defenses. Demonstrated expertise in guiding Study Initiation and Study Close-out processes in compliance with ICH-GCP, SOPs, and Regulatory Requirements. Adept at leveraging Technology & Tools for efficient Clinical Operations and achieving Study Milestones within Agreed Timelines. Armed with exemplary Advanced Leadership Skills, I excel in swift and effective Execution, keen observation, and polished Communication & Interpersonal Skills. Flexible and adaptable, I thrive in navigating the ever-evolving landscape of the pharmaceutical industry, consistently delivering high-quality results in Clinical Studies.
Therapeutic Experience: Oncology, CNS, Pain, Gastrointestinal, Diabetes, Device, Immunology, Cardiovascular Disease
Education & Certification PMP Certified Masters in Data Sciences – Ongoing (Rutgers) Bachelor of Science in Biology - Bloomfield College, Bloomfield, NJ (BS) Monitoring Oncology Clinical Trials - Barnett International Training (Certification) TMF For Sponsors Setup and Maintenance - Barnett International Training (Certification) Veeva Vault Clinical Operations (eTMF, CTMS, Study Startup, Site Connect) Veeva Vault Platform Configuration Track (System configuration and implementation)Ma
Employment History
Pacira Bioscience, Parsippany NJ
Sr Clinical Trial Manager II (Private Remote Contractor)
March 2021 – Present
Therapeutic Area: Pain
●Reporting (Timelines, Budgets, Resources):
Spearheaded comprehensive reporting mechanisms for Clinical Trial Management, utilizing Smart Sheets to track Study Progress, identify potential Roadblocks, and highlight key successes to Stakeholders and Clinical Operations leadership.
Managed and monitored Study Budgets and Resource Allocation, providing accurate forecasts and identifying cost-saving opportunities to ensure financial targets were met within the overall Budget Management strategy for Clinical Studies.
Developed and presented executive-level reports, including expertly created figures and listings, utilizing charts generated from Smart Sheets data to visually communicate Study Status and Timeline Adherence to Stakeholders and Clinical Operations leadership.
Escalated concerns/issues related to Timelines and Budget Management to senior management appropriately to ensure proactive Risk Mitigation and maintain Agreed Timelines.
Contributed clinical updates to cross-functional Project Team Meetings, ensuring transparency and alignment on Study Milestones and resource needs.
Utilized Smart Sheets for detailed tracking of site activation, enrollment progress, and data cleaning metrics, providing granular data for overall Clinical Trial Management reporting.
●Core Team Management:
Led and mentored a high-performing cross-functional Core Team, including Medical Directors, Data Managers, Supply Specialists, Quality Assurance, Biostatisticians, and CTAs, fostering a collaborative environment essential for effective Project Management and Clinical Operations.
Managed team Timelines and ensured timely completion of critical tasks through proactive follow-up and support, driving adherence to the overall Timeline Management plan for Clinical Studies.
Fostered a positive team culture, providing encouragement and celebrating milestones and small successes to maintain motivation and engagement within the Clinical Operations team, enhancing team performance and Execution.
Conducted weekly Core Team Meetings to review progress, address challenges, track action items, and ensure alignment on Study Goals and Clinical Trial Management objectives.
Delegated clearly defined Clinical Trial Management activities to Clinical Operations Specialists (COS) when assigned, ensuring deliverables were met with appropriate timeliness and quality while providing mentorship and training.
●Vendor Management:
Oversaw the entire Vendor Management lifecycle, from initial Vendor Selection processes, including evaluating Bid Defenses and conducting due diligence, to final contract execution for Clinical Services.
Negotiated itemized contracts and NDAs with clinical vendors (e.g., CROs, central labs, IRTs), ensuring favorable terms, clear Scope of Work (SOW), and compliance with Budget Management for effective CRO Oversight.
Conducted regular weekly meetings with key vendors to monitor performance against Agreed Timelines, address issues, and ensure alignment with Study Timelines and Clinical Operations requirements.
Assisted in determining which Clinical Operations services would be conducted internally and which would be outsourced to vendors, optimizing resource utilization and Budget Management.
Reviewed and approved vendor invoices, managing accruals and SOW changes in accordance with contract terms and Budget Management plans.
●Study Documents and SOPs:
Authored and contributed to the development of essential Study Documents and plans, including the Protocol Management Plan (PMP), Study Operations Manual, Informed Consent Document (ICD), Monitoring Plan, Tracking Forms, and other Study-Related Documents as required, ensuring compliance with ICH-GCP and internal SOPs.
Ensured all Study Activities were conducted in accordance with the approved Protocol, internal SOPs, ICH Guidelines, and relevant Regulatory Submissions.
Led implementation of Risk-Based Monitoring for assigned Clinical Studies, developing and adhering to the Monitoring Plan.
Reviewed and approved monitoring visit reports submitted by CRAs for assigned studies, ensuring data accuracy and site compliance with Study Documents and SOPs.
Coordinated and developed Study Protocols and amendments, ensuring alignment with the Clinical Development Plan (CDP) and Regulatory Requirements.
●Sites and Subjects:
Oversaw the evaluation, development, set-up, training, and monitoring of investigational sites participating in Clinical Trials, crucial for successful Site Management and Subject Recruitment.
Managed the Site Selection process, including overseeing feasibility assessments and ensuring sites had the infrastructure and experience to meet Subject Recruitment targets and conduct Clinical Studies in compliance with the Protocol and ICH-GCP.
Conducted monitoring oversight visits as needed to review Clinical Data for accuracy and completeness and resolve discrepancies in accordance with the Study Monitoring Plan, ensuring Data Integrity.
Maintained good relations with collaborators and trial sites to facilitate Site Development and Execution of Clinical Trials, fostering strong Site Management relationships.
Actively managed issues that could impact Study Progress at the site level, taking actions or making recommendations to solve issues to support compliance with the Protocol and Regulatory Requirements.
Bayer, Whippany NJ
Clinical Trial Manager II (Remote Contractor)
Dec 2018 – Nov 2020
Therapeutic Area: Oncology
●Reporting (Timelines, Budgets, Resources):
Provided strategic and operational leadership of Clinical Research Studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/WPs, reporting progress to Stakeholders.
Developed, managed, and reconciled overall Study Budgets but, providing regular financial reports and forecasts to senior management and the Project Team.
Maintained and updated data as appropriate in Project Management Tools, including CTMS, to track Timelines, resources, and budget against plan, facilitating comprehensive reporting.
Informed operational program leads and other leadership on overall Clinical Trial Plans, updated forecasting, and potential issues/mitigation strategies, contributing to transparent reporting for Clinical Operations.
Oversaw Study Execution utilizing available performance metrics and quality indicators, reporting on key performance indicators (KPIs) to the Core Team and Stakeholders.
Managed vendor scopes of work (SOW) per contract, quality, and budget; reviewed and approved vendor invoices; managed accruals and SOW changes, reporting financial status to the Budget Management team.
●Core Team Management:
Directed one or more cross-functional Study Teams, ensuring effective collaboration and communication among internal partners/stakeholders including Clinical Research, Project Management, CR&D Operations, and Affiliates.
Orchestrated regular interdepartmental Team Meetings involving Data Management, Safety, Regulatory Affairs, Biostatistics, Quality Control, Medical Affairs, and Site Management teams across three partnering companies, ensuring alignment and timely completion of critical milestones.
Successfully ensured timely completion of critical milestones within the Core Team, thereby maintaining accountability for Study Deliverables and advancing overall Project Timelines.
Developed, managed, and maintained Study Deliverables (e.g., Timelines, Study Plans) through collaboration with internal and external Stakeholders and the Core Team.
Demonstrated comprehensive mastery of Study Protocols, enabling effective and informed responses to complex operational inquiries from Clinical Research Associates, participating study sites, and internal Team Members, fostering strong team support.
●Vendor Management:
Participated in Clinical Service Provider (Vendor) Selection, specification development, and management/oversight, ensuring vendors met the requirements for Clinical Studies.
Managed vendor scopes of work (SOW) per contract, quality, and budget; reviewed and approved vendor invoices; managed accruals and SOW changes, ensuring effective Vendor Management and Budget Management.
Coordinated with external vendors such as Contract Research Organizations (CROs), Interactive Voice Response Systems (IVRS), drug depots, and diagnostic labs to ensure seamless management of sample shipments, image transfers, and other logistics, while maintaining high-quality standards, adhering to Timelines, and staying within budget.
Fostered relationships with external partners including Contract Research Organizations (CROs), Academic Research Organizations (AROs), and other Clinical Service Providers, essential for successful Clinical Operations.
Oversaw quality oversight of one or more Contract Research Organization (CRO) Teams, ensuring compliance with ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/WPs.
●Study Documents and SOPs:
Provided operational input into Study Documents such as synopsis, Protocol, ICF, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plan, Clinical Database edit specifications, and Clinical Study Report (CSR) development, ensuring compliance with SOPs and ICH-GCP.
Oversaw TMF set-up, ongoing quality review, and final reconciliation of Study Documents, including review of site Regulatory Documents/Packages and obtaining of appropriate country/site insurance, maintaining compliance with Regulatory Requirements.
Developed and coordinated Study Training for the Study Team, investigational sites, and vendors, ensuring adherence to the Protocol and SOPs.
Oversaw required country Regulatory Submissions, ensuring timely and accurate filing of necessary documentation.
Responsible for managing and reviewing Protocol Deviation logs to ensure each deviation was correctly categorized, initiating and leading ad hoc meetings to specifically address and resolve critical Protocol Deviations and long-standing queries, thereby enhancing the integrity and compliance of the Study Documents.
●Sites and Subjects:
Facilitated country and Site Feasibility/Selection processes, identifying sites capable of meeting Subject Recruitment targets and conducting Clinical Studies in compliance with the Protocol and ICH-GCP.
Oversaw investigational product (IP) supply forecasting/management and study-level IP reconciliation in collaboration with IMSC, ensuring sites had the necessary supplies for Subject Management.
Developed Subject Recruitment/Retention Strategies and related initiatives, supporting sites in enrolling and retaining subjects in Clinical Trials.
Ensured clinical monitoring quality and adherence to established processes and plans for Site Management, overseeing monitoring visits conducted by CRAs.
Efficiently managed end-to-end Study Close-Out, overseeing site close-out visits, drug returns, and destruction in compliance with FDA and GCP, ensuring all site and subject activities were completed.
Successfully closed out over 500 sites, ensuring all essential documents were archived in the eTMF and finalizing all site payments as part of the Study Close-out process.
Allergan Pharmaceuticals, Jersey City, NJ
Clinical Trial Manager 1 (Hybrid)
Sep 2015 – Dec 2018
Therapeutic Area: GI (Gastrointestinal)
●Reporting (Timelines, Budgets, Resources):
Led a multi-country Phase III and IIIb Clinical Trial, overseeing 600+ sites and 1,500+ subjects, ensuring GCP Compliance, Data Integrity, and timely Milestone Achievements through strategic coordination and adaptive Clinical Trial Management, reporting progress to Stakeholders.
Successfully negotiated cost adjustments with vendors by critically evaluating and modifying submitted RFPs in alignment with changing project requirements, demonstrating an in-depth understanding of contractual terms and Financial Planning within the Clinical Trial landscape, reporting budget impacts.
Utilized in-depth knowledge of Regulatory Frameworks to ensure Data Integrity, participant safety, and ethical conduct throughout all stages of the Clinical Trial, contributing to accurate reporting.
Managed and optimized relationships with 3-4 key vendors, including CROs, labs, eDiary systems, and drug logistics providers, leveraging in-depth knowledge of Regulatory Standards and performance metrics to ensure GCP Compliance, cost efficiency, and a 15% improvement in Project Timelines, reporting on vendor performance.
Spearheaded the meticulous orchestration of Clinical Study Data Management by overseeing end-to-end processes, from initial reception to validation and quality-controlled transfer to sponsors, ensuring accurate data for reporting and analysis.
●Core Team Management:
Served as the primary point of contact for all Protocol-Related Questions and quality/compliance issues and escalated queries to subject experts when necessary, facilitating efficient communication within the Core Team.
Conducted in-depth Clinical Data and Protocol Deviation Analyses in collaboration with cross-functional Teams to promptly address and resolve issues, ensuring data quality and compliance with the Protocol.
Successfully led Study Closeout and Database Lock procedures in full compliance with GCP and Regulatory Guidelines, coordinating cross-functional Teams to resolve data queries, validate datasets, and expedite statistical analysis.
Spearheaded high-stakes Bid Defense Meetings with Contract Research Organizations (CROs), employing an in-depth understanding of Clinical Trial Protocols, budget considerations, and Regulatory Requirements to successfully negotiate and secure optimal partnerships for trial execution, collaborating with the Project Team.
Ensured GCP Compliance, Data Integrity, and timely Milestone Achievements through strategic coordination and adaptive Clinical Trial Management, working closely with the Core Team to achieve study goals.
●Vendor Management:
Managed and optimized relationships with 3-4 key vendors, including CROs, labs, eDiary systems, and drug logistics providers, leveraging in-depth knowledge of Regulatory Standards and performance metrics to ensure GCP Compliance, cost efficiency, and a 15% improvement in Project Timelines.
Successfully negotiated cost adjustments with vendors by critically evaluating and modifying submitted RFPs in alignment with changing project requirements, demonstrating an in-depth understanding of contractual terms and Financial Planning within the Clinical Trial landscape.
Spearheaded high-stakes Bid Defense Meetings with Contract Research Organizations (CROs), employing an in-depth understanding of Clinical Trial Protocols, budget considerations, and Regulatory Requirements to successfully negotiate and secure optimal partnerships for trial execution.
Served as the primary point of contact for all Protocol-Related Questions and quality/compliance issues related to vendors, escalating queries to subject experts when necessary to ensure effective Vendor Management.
Conducted meticulous evaluations of eDiary User Acceptance Testing (UAT) and Local Institutional Review Board-Informed Consent Forms (IRB-ICFs) to guarantee complete alignment with Study Protocols, Good Clinical Practice (GCP) standards, and sponsor expectations, working closely with vendor teams.
●Study Documents and SOPs:
Managed the development and amendment of Protocols, ICFs, and CSRs, ensuring compliance with ICH-GCP and Regulatory Requirements.
Conducted in-depth Clinical Data and Protocol Deviation Analyses in collaboration with cross-functional teams to promptly address and resolve issues, ensuring data quality and compliance with Study Documents.
Conducted meticulous evaluations of eDiary User Acceptance Testing (UAT) and Local Institutional Review Board-Informed Consent Forms (IRB-ICFs) to guarantee complete alignment with Study Protocols, Good Clinical Practice (GCP) standards, and sponsor expectations, ensuring the accuracy of Study Documents.
Spearheaded pre-approval inspection readiness by rigorously aligning Clinical Trial Processes with FDA, EMA, and ICH-GCP Guidelines; conducted comprehensive internal audits, rectified compliance gaps, and trained cross-functional teams to ensure a seamless Regulatory Inspection experience, demonstrating expertise in Regulatory Compliance.
Utilized in-depth knowledge of Regulatory Frameworks to ensure Data Integrity, participant safety, and ethical conduct throughout all stages of the Clinical Trial, upholding the standards outlined in Study Documents and SOPs.
●Sites and Subjects:
Led a multi-country Phase III and IIIb Clinical Trial for Viberzi (eluxadoline) in IBS-D, overseeing 600+ sites and 1,500+ subjects, ensuring GCP Compliance, Data Integrity, and timely Milestone Achievements through strategic coordination and adaptive Clinical Trial Management at the site level.
Ensured GCP Compliance, Data Integrity, and timely Milestone Achievements through strategic coordination and adaptive Clinical Trial Management, focusing on site performance and Subject Management.
Served as the primary point of contact for all Protocol-Related Questions from sites, ensuring sites had the necessary information to manage subjects and conduct Clinical Studies compliantly.
Successfully led Study Closeout and Database Lock procedures in full compliance with GCP and Regulatory Guidelines, coordinating with sites to ensure all site and subject data were finalized.
Utilized in-depth knowledge of Regulatory Frameworks to ensure Data Integrity, participant safety, and ethical conduct throughout all stages of the Clinical Trial, with a focus on site-level compliance and Subject Safety.
inVentiv Health Clinical, Princeton, NJ
CRA I to CRA II (Remote)
Jul 2010– Sep 2015
Therapeutic Area: Oncology and CNS
Responsibilities:
●Conducted interim site visits to assess and ensure protocol adherence.
●Executed and Reviewed Feasibility Questionnaire (FQ), Qualification Visits, Site Initiation Visits (SIV) for an allocated portfolio of 5 to 8 studies and 40 to 50 sites for Site Activation.
●Conducted regular site visits to ensure protocol compliance, including Site Initiation Visits (SIV) and Interim Monitoring Visits (IMV).
●Verified the accuracy and completeness of Case Report Forms (CRFs) against source documents.
●Acted as the primary point of contact for clinical sites, answering queries and resolving issues to maintain strong site relationships.
●Assisted in the preparation and maintenance of regulatory documents for trial initiation, ongoing study activities, and study closure.
●Reviewed informed consent procedures and documentation to ensure compliance with ethical and legal requirements.
Proficient In: Clinical Trial Management, Clinical Operations, ICH-GCP, SOPs, Monitoring, Source Data Verification (SDV), Query Resolution, Regulatory Documents, Site Communication, Data Management systems, CTMS, Study Initiation, Site Activation, Protocol Adherence, Subject Recruitment, Subject Retention, Study Close-out, Timeline Management, Budget Management, Vendor Management, Risk Management, Stakeholder Engagement, Technology & Tools, Electronic Data Capture (EDC), Trial Master File (TMF), Clinical Research, Drug Development, Clinical Studies, Regulatory Compliance, Ethics, Communication & Interpersonal Skills, Project Management, Team Management.
GlaxoSmithKline (GSK), Parsippany, NJ
Data Analyst / Data Entry
Nov 2008-Sep 2010
Therapeutic Area: N/A
Responsibilities:
●Performed quality controls on entered data for data discrepancies.
●Entered and verified assay results in Clinical Lab Databases (CLIN Lab Direct Capture).
●Completed verification of data entries and cross-checked with Global Clinical sites.
●Identified errors/inconsistencies in CRF data and ensured their resolutions in the Clinical Database.
●Generated various study-related reports/listings to aid the cleaning of the database before database lock.
Proficient In: Data Management, Data Entry, Data Validation, Data Cleaning, Query Generation, Database Systems, Data Listing, Data Reporting, Clinical Research Data, Accuracy, Attention to Detail, Microsoft Excel, Smart Sheets, Clinical Trials, Study Data, Data Integrity, Database Lock, Clinical Operations, SOPs, Regulatory Compliance, GCP, Study Documents, CRF, EDC, Statistical Methods (basic understanding), Technology & Tools, Data Analysis, Project Management (data-focused tasks), Timeline Management (data entry/cleaning timelines).
Skills
Project & Team Management:
●Clinical Trial Management, Project Management, Cross-functional Team Leadership, Team Building, Mentoring, Performance Monitoring, Resource Allocation, Meeting Facilitation, Action Item Tracking, Agreed Timelines, Execution, Advanced Leadership Skills.
Clinical Operations:
●Clinical Operations, Site Management, Vendor Management, CRO Oversight, Monitoring (On-site, Remote, Central), Feasibility Assessment, Site Selection, QV, SIV, Subject Recruitment, Subject Retention, Protocol Adherence, ICH-GCP, SOPs, Study Initiation, Study Close-out, Clinical Studies, Drug Development.
Vendor Management:
●Vendor Management, Vendor Selection, Bid Defense, Contract Negotiation, NDA Review, Performance Oversight, Relationship Management, Clinical Service Providers, CROs.
Financial Acumen:
●Budget Management, Financial Forecasting, Cost Control, Resource Planning, Invoice Review, Accruals, Financial Planning.
Regulatory Compliance & Ethics:
●ICH-GCP, Regulatory Submissions, Ethics Committee Submissions, Study Documents, Essential Documents, Audits, Inspections, FDA, EMA, Regulatory Authorities' regulations/guidelines, Regulatory Frameworks, Ethical Standards, Integrity.
Communication & Interpersonal Skills:
●Stakeholder Communication, Cross-functional Collaboration, Presentation Skills, Negotiation, Conflict Resolution, Written and Verbal Communication, Outstanding Communicator, Networking Skills, Cross-cultural Global Environment.
Data Management & Analytics:
●Data Management, Data Cleaning, Query Resolution, Data Validation, Data Analysis (basic), Reporting, Smart Sheets, Clinical Data, EDC, CRF, Database Lock, Data Integrity, Statistical Methods.
Risk Management:
●Risk Management, Risk Identification, Risk Assessment, Risk Mitigation, Developing Risk Management Plans, Proactive Planning, Issue Resolution.
Stakeholder Engagement:
●Stakeholder Engagement, Managing Relationships (Sponsors, Investigators, Regulatory Bodies), Presenting Project Updates, Cross-functional Collaboration, External Partners, Regulators, Internal Stakeholders and Collaborators.
Technology & Tools:
●CTMS, EDC, IRT/IVRS, eTMF, Smart Sheets, Microsoft Project, Microsoft Office Suite (Excel, PowerPoint, Word), Clinical Lab Databases, SIP - Shared Investigator Platform, Veeva Vault, Medidata, Oracle's Siebel CTMS, Impact Harmony, Bicollinear, RDC, Inform, IMB clinical Dev, ALMAC, Bracket, Trial Interactive.
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