Summary
Overview
Work History
Education
Skills
Professionalaccomplishments
Therapeuticexperience
Systemsexperience
References
Hobbies including Reading, Traveling and Sports
Timeline
Generic

Odeyemi Samson

Aubrey,TX

Summary

Seeking a senior position in the clinical research industry where my diverse oversight, management skills, and experience will be used to oversee the initiation, progress, and conduct of the clinical trials, and ensure scientific integrity of data collected as well as the protection, safety, and well-being of human study subjects both in Pharmaceutical and Medical Device organizations

Overview

16
16
years of professional experience

Work History

Senior CRA/Clinical Study Manager

Teleflex Inc.
07.2021 - Current
  • Assisting the Director and Director of Clinical Operations in the site feasibility process and investigator selection
  • Organize and execute all clinical operations activities at the sites from study start up at the Site Initiation Visit (SIV) to closure activities
  • Providing oversight and be a resource to study sites to address protocol and procedural questions
  • Conducting regular meetings/teleconferences with study sponsors, site staff and internal staff
  • Providing regular study updates to the upper management and internal Clinical Investigative staff including enrollment timelines and clinical activity
  • Responsible for cross-functional team communication and effectiveness
  • Reviewing study documents including, but not limited to the protocol and informed consent form (ICF) at study start and all amendments
  • Tracking study parameters with the end goal to assess progress of timeline, budget, and performance against industry benchmarks
  • Negotiating CTA and Budgets with hospitals/sites across the USA
  • Managing and prioritizing project deliverables per study timelines
  • Assisting in reconciliation of clinical safety data against the safety database
  • Participated in the implantation and user acceptance testing (UAT) of the electronic data capture (EDC) system
  • Reviewing case report form (CRF) completion guidelines and validation specifications (in tandem with the lead Data Manager)
  • Managing and communicating with outside vendors
  • Participating in departmental SOPs, and work instruction development and updates
  • Managing CRAs to ensure projects are completed within the allocated budget, scope of work and/or expectations
  • Preparing training materials and participate in training of CRAs to ensure efficiency
  • Assessing CRA job performance and taking necessary actions for escalation to upper management
  • Acting as a point of escalation for site and CRA issues, and following up until final resolution
  • Reviewing and approving monitoring trip reports, follow up letters and associated trip expense reports
  • Responsible for quality and completeness of the Investigator Site Files (ISFs) with the Trial Master File (TMF) for assigned studies, and assist the Director of Clinical Operations in ensuring quality of the study-level documents
  • Participating in continuing education and professional associations to maintain awareness of current treatment guidelines and industry best practices
  • Providing ongoing training and support to the clinical team
  • Conducting team meetings and ensuring regular and effective communications
  • Mentoring CRAs, advising on critical specific study issues, and providing performance feedback to management and clinical team members
  • Building solid understanding through utilizing appropriate clinical tools and processes
  • Ensuring project consistency within and across assigned projects by following Teleflex SOPs and/or guidelines
  • Creating and managing the Clinical Monitoring Plan (CMP), including regular review (annual at a minimum) and updates to the plan
  • Timely CRA trip report review, management, resolution of issues, and escalation
  • Includes tracking of trip report packet (confirmation letter, report, follow up letter) submissions
  • Timely review of Protocol deviations, site action items, and frequently asked questions
  • Track and escalate items as appropriate
  • Responsible for ongoing analysis of enrollment activities/trends and escalation/mitigation to Director of Clinical Operations
  • Working with Director of Clinical Operations to develop strategic and tactical plans for ensuring enrollment targets are met at participating sites
  • Working with team members to develop monthly study newsletters.

Senior Clinical Research Associate/Lead CRA

Celerion Inc.
10.2019 - 07.2021
  • Responsible for ensuring the quality of the clinical monitoring deliverables and for identifying and mitigating risks
  • Managed monitoring team site assignments and visit schedules to ensure CMP metrics are maintained
  • Conducted several SQV, SIV, IMV and COV Visits
  • Oversaw CRAs completion of remote site management activities
  • Conducted project co-monitoring visits and team training to assure the quality of the clinical monitoring deliverables and for identifying and mitigating risks
  • Provided coaching/mentoring to the monitoring team
  • Developed project-specific training materials for team
  • Conducted internal team calls and Sponsor calls (as needed)
  • Served as site/CRA contact for protocol clarifications and subject enrollment
  • Served as Sponsor contact for monitoring/site issues
  • Made updates to study specific CTMS and/or project working files as appropriate
  • Participated in monthly project review meeting and provide budget projections for monitoring services units
  • Monitored and planned for resolution of data backlog by working with clinical management
  • Collaborated with Lead Data Manager to develop CRF completion guidelines and edit specifications
  • Supported the development of working relationships with regulatory authority and IRB/IEC personnel within the constraints of any local guidelines and regulations
  • Agreed and developed corrective and preventative actions (CAPA) with PI and site personnel to close all open issues/deviations
  • Assisted Senior CPM & Associate Director in the execution of various study related projects
  • Proactively managed issues to appropriate resolution and closure
  • Obtained critical information to enable the generation of IP documentation
  • Attended project and department meetings
  • Completed weekly time and expense entries
  • Maintained good standing with internal training requirements
  • Assumed CRA duties and responsibilities when required
  • Conducted other activities as needed for any given project.

Senior Clinical Research Associate II

Abbot Labs.
10.2016 - 09.2019
  • Conducted SDV and SDR to ensure clinical trials data were submitted to data management in a timely fashion
  • Identified issues that might impact on the conduct of the study and ensured appropriate closure of all issues
  • Proactively managed a greater investigator site workload commensurate with my experience so that studies ran efficiently, and key study objectives were met
  • Negotiated Budgets and contracts with sites
  • Prepared Manual Operations (MOP) for CRAs and Clinical staff
  • Assisted in the development of study materials such as ICFs, CRFs, Protocols, etc
  • Authored Study team Quarterly Newsletter
  • Conducted SQV, SIV, IMV, and COV
  • Performed Case Report Form review
  • Reviewed ICFs against ICF Checklist
  • Responsible for all aspects of site management from collaboration on site selection to study closeout
  • Participated in Investigator meetings
  • Ensured studies ran in line with ICH/GCP, local laws and Sponsor SOPs and procedures
  • Ensured patient safety was maintained and all safety issues (AEs and SAE etc.) were documented and reported correctly according to all relevant local and international regulatory requirements
  • Trained site staff on the protocol, protocol amendments, and Sponsor processes
  • Understood the product, the protocol, and the therapy area in sufficient detail to be able to have appropriate discussions with the investigator teams
  • Participated in contract and budget negotiations
  • Site involvement at a level with CRAs when issues arose
  • Ensured all data monitored met target quality standards
  • Ensured data were entered into Sponsor systems in a timely manner
  • Reported on progress of all studies at the investigational sites after each visit to ensure all relevant personnel were aware of progress against plan and any issues that might have occurred
  • Ensured all issues were correctly identified and cataloged.

Senior CRA

PRA
08.2012 - 09.2016
  • Responsible for study start-ups and study conduct activities including drafting ICF study-specific template and TMF plan, approving study-specific essential documents list, managing, and communicating the status of study progress and activities
  • Conducted several Visits including Site Qualification Visit, Site Initiation Visits, Interim Monitoring Visits, Close Out Visits and For-Cause Ad hoc Visits
  • Partnered with cross-functional teams (e.g., clinical data management, field teams, Regulatory, Safety) with query management, data reviews, and resolution
  • Oversee the work of the junior CRAs
  • Provided coaching and training to lower-level employees
  • Lead in the investigation of all discrepancies in study documentation, by applying clinical protocol knowledge and GCP and develop processes to mitigate reoccurrence throughout study phases
  • Lead in assessing current and new processes, identifying opportunities, and implementing solutions to improve process efficiency within and across related functional areas
  • Conducted site reviews of associated documentation and lead in internal and competent authority audits to ensure documents are compliant with Good Documentation Practices and SOPs, and US and OUS regulations
  • Partnered with clinical project manager in leading regular team meetings
  • Prepared materials for steering and investigator meetings
  • Assisted with the development and review of study-related materials including Case Report Forms (CRFs), Protocols/CIP, SOPs, Informed Consent Forms (ICFs), and Monitoring Plans
  • Participated in the identification and recruitment of investigators, and assist in the development of subject recruitment strategies and materials
  • Trained and evaluated monitoring staff
  • Managed study sites, including preparing for, and conducting site qualification, initiation, interim monitoring, closeout, For-cause monitoring visits, Risk-based and remote monitoring
  • Participated in contract and budget negotiations
  • Served as a primary point of contact for study site personnel to answer questions and resolve any study-related issues
  • Ensured studies run efficiently within the allocated budget
  • Managed select study vendors by ensuring compliance with the statements of work and protocols
  • Mentored junior level Clinical Research Associates
  • Proactively identify project issues and contributed to problem resolutions
  • Ensured that all visits are conducted according to FDA regulations, ICH/GCP guidelines, and SOPs
  • Ensured adequate reporting/tracking of all AEs, SAEs, protocol deviations, and subject status
  • Identified areas requiring follow-up and improvement at each clinical study site, and recommend and implement corrective action (CAPA)
  • Confirmed that data recorded on CRF were accurate, complete, and verifiable against source documents
  • Oversaw the collection of regulatory documents required for CTM shipment clearance
  • Ensure proper maintenance of required essential documents at the site level
  • Assist with set-up, maintenance, and reconciliation of Trial Master File
  • Prepared and attended project team meetings, and provide updates on project status and site-specific performance
  • Assisted with overseeing other study vendors, including co-monitoring
  • Worked collaboratively and effectively in a project team outsourced environment
  • Attended and participated in internal and external training sessions.

CLINICAL TRIAL ASSOCIATE/CRA I/II

Theorem
06.2008 - 07.2012
  • Responsible for coordinating and verification of all in-house documents generated by study sites, monitors and other related sources involved in clinical research projects in the US
  • Reviewing of study and research documents for completeness and accuracy
  • Served as a point of contact for field-based monitors and study sites
  • Tracked study documents at site level
  • Assisted in the planning and organizing of investigator meetings and trainings
  • Proactively identified study-related issues arising from time to time and provided recommendations for resolution
  • In-house tracking of activities at study sites to ensure adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOP) and all study protocols
  • Collected, reviewed, and processed regulatory documents from investigator sites
  • Participated in projects team meetings
  • Prepared all site documents and visit reports for filing in the Trial Master File
  • Assisted in other areas of clinical study projects as assigned.

Education

Bachelor of Science in Health Science Administration -

UNIVERSITY OF YORK

GCP -

Skills

  • Proven expertise in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file)
  • My extensive Medical device professional experience covers clinical operations, strategic planning, project execution and process improvement
  • Demonstrated leadership in planning, initiation, execution, and closure of global clinical studies (including pre- and post-market studies), along with Investigator Initiated Studies (IIS)
  • Proven abilities in organizational design, change management, and influence of cross-functional teams through motivational management Customer-focused with strong relationship-building and communication skills
  • Excellent written and verbal communication skills and interpersonal relationship skills
  • Excellent problem-solving and critical thinking skills
  • Full knowledge and understanding of procedures, and international regulatory guidelines relevant to clinical protocols
  • Full understanding of regulatory submissions, reporting, and audits
  • Ability to manage confidential information with discretion
  • Strict attention to detail
  • Ability to interact professionally with all organizational levels
  • Ability to manage competing priorities in a fast-paced environment
  • Ability to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
  • Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
  • GCP Knowledge
  • Adverse event reporting
  • Site monitoring
  • Clinical trial management
  • Clinical Data Management
  • Patient recruitment
  • Investigator relations
  • Protocol development
  • Clinical Research
  • Study design
  • Ethics Committee Submissions
  • Regulatory Submissions
  • Training and mentoring
  • Standard Operating Procedures
  • Fluent in English
  • Data Management
  • Study coordination
  • Teamwork and Collaboration
  • Problem-Solving
  • Time Management
  • Good Clinical Practices
  • Attention to Detail
  • Problem-solving abilities
  • Multitasking
  • Multitasking Abilities
  • Reliability
  • Excellent Communication
  • Organizational Skills
  • Team Collaboration
  • Active Listening
  • Effective Communication
  • Adaptability and Flexibility
  • Decision-Making
  • Relationship Building
  • Study protocols
  • Research SOPs understanding
  • Informed consent
  • Team building
  • Task Prioritization
  • Research experience
  • Self Motivation
  • Interpersonal Skills
  • Analytical Thinking
  • Trial management
  • Goal Setting
  • Professionalism
  • Interpersonal Communication
  • Time management abilities
  • Continuous Improvement
  • Adaptability
  • Written Communication
  • Quality Assurance
  • Documentation requirements
  • Records Management
  • Professional Demeanor
  • Problem-solving aptitude
  • Clinical trial expertise
  • Protocol Review
  • Analytical Skills
  • Disease Research

Professionalaccomplishments

  • Wrote Clinical Study Protocol for the Auto Endoscopic (AE05M) study- "A Prospective Observational Clinical Registry Study to assess Safety and Performance of AE05ML for Polymer Clip Delivery in Laparoscopic Procedures"
  • Co-developed Study Protocol for "Phase 2 Multisite, Double-Blind, Prospective, Randomized, Crossover, Adequate and Well Controlled Clinical Trial to Assess the Non-Inferiority of Autologous Freezer Dried Plasma (FDP) to Fresh Frozen in Reversing the Anticoagulation Effects of Warfarin in Healthy Volunteers"
  • Developed Study Protocol for A Prospective Evaluation of the Weck EFx Shield Fascial Closure System When Used by Clinicians in Surgical Resident Training
  • With minimal help from my team, I single-handedly initiated and launched the AE05ML Study, identified participating hospitals/Surgeons and successfully negotiated budgets and Contracts with the hospitals
  • Developed Master Informed Consent Form
  • Developed ICF Checklists
  • Developed study-specific Risk Management Plan
  • Developed study-specific Monitoring Plans
  • Developed study specific Source Documents and Regulatory Binder
  • Developed CRA handbook to aid CRAs in the conduct of site visits in the most efficient and effective manner
  • Participated in the development, implementation, UAT and Edit checks of the newly installed Veeva Vault
  • Trained GCO team members on the use of Veeva Vault CDMS, CTMS and eTMF
  • Helped to Standardize Monitoring system across the entire GCO to achieve operational uniformity
  • Developed Manual of Procedure
  • Participated in the Development of CRFs
  • Single handedly negotiated budgets and contracts with sites resulting in saving of hundreds of thousands of dollars for my Company. My Director/Manager was so impressed by this, that she announced to the general audience at one of our global meetings
  • Attended Investigator Meetings
  • Participated in Vendor selections and Management
  • With the help of cross-functional teams, Launched and initiated a sponsor-led Lyme Vaccine Disease Study, and helped in the identification of viable sites across the country, responsible for monitoring and maintenance of the study at 17 sites across the USA
  • Initiated, launched and single-handedly monitored 4 Sponsor-led hepatic studies at several sites across the USA
  • Initiated, launched and single-handedly monitored 3 sponsor-led Renal Studies from initiation conduct, progress to enrollment and Close Out
  • Participated in in Sponsor-led COVID-19 vaccine study at various sites across the USA
  • Developed Greenlight Checklists
  • Developed Study Timelines
  • Developed SQV and SIV slides for several studies
  • Ensured sites' adherence to ICH-GCP and compliance with local, international and all applicable regulations by regularly meeting with sites
  • Attended Internal Sponsor-led audit at research sites
  • Co-authored the Clinical Study Protocol for Transcatheter Mitral Valve Study, "An Expanded Clinical Study of Mitral Valve Regurgitation"
  • Submission of the Protocol and Master ICF, and obtaining IRB approvals
  • Single-handedly Developed Manual of Procedure for GCO
  • Developed Master Informed Consent for TMV Study and ICF Checklist
  • Introduced excel spreadsheet for budget negotiations
  • Developed budget comparable spreadsheets to aid in budget negotiations, whereby, one could see at a glance the comparable figures within the same area or areas with similar costs of living
  • Developed Study Tracker and Contact List
  • Developed and produced Quarterly Study Newsletter for circulation to the sites to provide updates on study progress
  • Responsible for coordinating and verification of all in-house documents generated by study sites, monitors and other related sources involved in clinical research projects in the US
  • Reviewing of study and research documents for completeness and accuracy
  • Served as a point of contact for field-based monitors and study sites
  • Tracked study documents at site level
  • Assisted in the planning and organizing of investigator meetings and trainings
  • Proactively identified study-related issues arising from time to time and provided recommendations for resolution
  • In-house tracking of activities at study sites to ensure adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOP) and all study protocols
  • Collected, reviewed, and processed regulatory documents from investigator sites
  • Participated in projects team meetings
  • Prepared all site documents and visit reports for filing in the Trial Master File
  • Assisted in other areas of clinical study projects as assigned

Therapeuticexperience

  • Cardiovascular, mitral regurgitation, aortic valve replacement, congestive heart failure, heart arrhythmias (tachycardia / bradycardia), pulmonary arterial hypertension, syncope, 5
  • Renal, acute kidney injury, end stage kidney disease, 3
  • Gastroenterology, fecal incontinence, IBS (C, D & M), 3
  • Urology, interstitial cystitis, overactive bladder, urge / stress urinary incontinence, 2
  • Infectious Disease - HIV, 2
  • Oncology - Breast Cancer, Phase I, Phases II & III, 3
  • CNS - Dementia, Phases II & III, 2
  • Tobacco-Nicotine Study, 1.5
  • Schizophrenia, 1
  • Impaired Hepatic Function (IHF), Phases 1- II, 3
  • Covid-19, 1.5
  • Sleep Apnea, Phase III-IV, 2
  • Pancreatitis, Phases II & III, 1
  • Ischemic stroke, Phase III, 2
  • Rare Disease- Lyme Disease Vaccine Study, Phases II-III, 3.67
  • Auto Endoscopic Laparoscopic Device Study, 2.5

Systemsexperience

  • Oracle Clinical
  • Medidata Rave
  • Sibel
  • E-Clinical
  • Viedoc
  • Wingspan
  • Omnicom Trial Master
  • Veeva Vault

References

Available on Request

Hobbies including Reading, Traveling and Sports

My reading and writing hobbies include writing articles for my church, developing clinical study materials, and reading clinical research publications. I love traveling to other parts of the world as this avails me the opportunity to learn about other cultures and to see the world from another view lens. I love all sports but I am particular about soccer, boxing and tennis.

Timeline

Senior CRA/Clinical Study Manager

Teleflex Inc.
07.2021 - Current

Senior Clinical Research Associate/Lead CRA

Celerion Inc.
10.2019 - 07.2021

Senior Clinical Research Associate II

Abbot Labs.
10.2016 - 09.2019

Senior CRA

PRA
08.2012 - 09.2016

CLINICAL TRIAL ASSOCIATE/CRA I/II

Theorem
06.2008 - 07.2012

Bachelor of Science in Health Science Administration -

UNIVERSITY OF YORK

GCP -

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Odeyemi Samson