Summary
Overview
Work History
Education
Skills
Core Therapeutic Area
Clinical Trial Management Experience
Professional Overview
Timeline
Generic

Tamika Thomas

Dallas,TX

Summary

Professional Goal: Continue my career in Clinical Trials and to develop into the Associate Director

As an accomplished Sr. Clinical Project Manager and Clinical Research Associate for more than 20 years of experience, I have demonstrated a proven track record of successfully leading and overseeing complex clinical trials and projects within the pharmaceutical, biotechnology or medical device industries. My expertise lies in driving cross-functional teams to deliver high-quality results within budget and timelines constraints while ensuring compliance with regulatory requirements and industry standards.


Throughout my career, I have honed my skills in strategic planning, risk management, resource allocation, vendor management and stakeholder communication, allowing me to effectively navigate the challenges in here's in clinical project management. My strong leadership abilities enable me to motivate and mentor teas, fostering a collaborative and high-performance work environment that consistently delivers on project objects.


My commitment ot excellence, coupled with keen attention to detail and results driven mindset, had routinely lead to successful completion of pivotal clinical initiatives, u contribution to the advancement of groundbreaking therapies and treatment.


In pursuit of new opportunities to apply my extensive experience and make meaningful impact, I am eager to bring my strategic vision and operational acumen to an organization posed for growth and innovation in the realm of clinical research and development.


Overview

24
24
years of professional experience

Work History

Clinical Study Lead

Novo Nordisk
02.2023 - Current
  • Responsible for operational aspects of managing clinical site performance through coordination and communication with In-House CRAs, Field Based CRAs and the Trial Manager (TM) for assigned trials, within the Trial Management (TM) function of North America Clinical Operations (NACO)
  • Oversees site performance for the lifecycle of assigned trials (e.g., start-up, recruitment, retention, quality, data entry, etc.), including tracking of trends and reporting of key metrics
  • In collaboration with the Trial Manager, support, prepare for and follow-up on audits & inspections
  • Share information, collaborate, and provide relevant input and guidance to other areas within NACO, CMR and global partners
  • Demonstrate technical expertise within responsibility areas, stay up to date on new practices and build knowledge of emerging trends and advances within area
  • Lead Trial CORE Team Meetings and other relevant teams
  • Reviews and approves monitoring visit reports for assigned sites
  • Accountable for ensuring that any issues are escalated as appropriate to the Trial Manager
  • Identifies/escalates any risks to trial delivery and contributes to mitigation development and deployment
  • Develops regional site communication including key updates and information
  • Active coaching, mentorship and contribution to training of NACO staff to build insight and talent.

Project Manager II

OncoBay Clinical Research
10.2021 - 09.2022
  • Project lead for two study projects
  • Lead study-start up and external vendor management
  • Managed a project as a project manager overseeing clinical research studies and ensuring compliance with GCP, relevant SOP, and regulatory documents
  • Led project team to ensure quality, and timelines, including ensuring the quality of clinical monitoring and site management deliverables
  • Accounted for the financial performance of each assigned project, including reviewing study budgets, time, forecasting, expenses, and invoices
  • Reviewed the content and quality of site monitoring documentation to ensure they represent site management activities and conduct, for (PSV-IVM)
  • Participated in representing the company to the client, ensuring satisfaction levels are met and statuses of deliverables effectively
  • Collaborated with the project team to plan and coordinate, to present at internal and external meetings
  • Coordinated and facilitated kick-off meetings with sponsors and vendors
  • Facilitated team training following the protocol and/or project requirements, including therapeutic, protocol
  • Specific, and process training
  • Drafted and organized with the Associate Director of SSU study plans
  • In addition to vendor DMP, SAP, and SMP plans
  • Accountable for all project deliverables for each project assigned.

Sr. Clinical Development Manager

Novartis
01.2019 - 05.2021
  • Sr
  • Project Lead for study-start up, maintenance, and close-out
  • Contributed to all trial deliverables, under the oversight of the Associate Director and the Clinical Development Director, according to timelines, accrual budget, operational procedures
  • Assisted with circulating contract orders for final signature for all sites, vendors, and third parties While liaison communication between parties
  • Assisted with creating purchase orders for internal final signature, while liaison with communication between all signatory
  • Managed all invoices provided by vendors and third-party for processing
  • Developed specific sections of the protocol and related documents, study tools, guidelines, and training materials
  • Organized and coordinated various trial advisory committees (e.g., Data Safety Monitoring Board, Steering Committee)
  • Ensured trial information/results are reported within relevant trial repositories and tracking systems (e.g., trial results registries)
  • Contributed to the development of clinical outsourcing specifications (as required) to facilitate the bid process and selection of vendors; managed interface with vendors in cooperation with line functions; ensured vendors meet quality standards; contributed to the development/amendment of vendor contracts
  • Contributed to the development of electronic Case Report Forms (eCRFs), edit checks, eCRF completion guidelines, data review plan (DRP), and trial statistical analysis plan (SAP) in collaboration with the Trial Data Manager, Trial Statistician, and Statistical Programmer
  • Managed interactions with relevant line functions e.g., data management and drug supply management
  • Conducted study site visits as required
  • Ensured proper handling of study start-up activities and management, eCRF validation, Serious Adverse Event (SAE) management, and reporting according to SOPs, including clinical trial site documentation management
  • Ensured proper handling of all study close-out activities including but not limited to site close-out visits, final drug accountability, and Trial Master File (TMF) inspection readiness.

Lead Clinical Research Associate

Ortho Clinical Diagnostics
06.2018 - 11.2018
  • Assisted with the management of activating sample collection and testing sites, during the study start-up and maintenance phase
  • Participated with the study project team, while supervising three in-house CRAs
  • Provided requested escalation from in-house CRAs, who need assistance with non-responsive study sites
  • Organized and delivered various reports and metrics to the clinical affairs department and project management
  • Scheduled and coordinated meetings, preparing agendas, presentation materials, and minutes for clinical study team meetings and other study-related meetings
  • Collated data for assessments such as site feasibility and site selection; per therapeutic area
  • The main point of contact for active subject enrollment, while distributing on a weekly basis to upper management
  • Reviewed study documents such as informed consent forms, and case report forms and facilitates study document reviews per company standard operating procedures
  • Tracked monitoring visits, by following the monitoring plan
  • In addition, escalated any issues or delays to the assigned project manager
  • Reviewed Monitoring Visit Reports (MVRs/IMVs) and generated queries for resolution
  • Monitored and updated investigator/site status for the trial and supports with clinical trial registry postings
  • Performed scheduled reconciliations and QC audits of study Trial Master File (TMF) per specific protocols
  • Managed and maintained team SharePoint and/or shared drive sites, as needed
  • Activated communication with assigned sites for study start-up activities
  • Evaluated in-house CRAs and site performance compliance with ICH-GCP, SOP, Local Laws & Regulations, Protocol Monitoring Plan, and associated documents
  • Activated participation in establishing best practices through strategic planning and training.

Clinical Study Specialist

Regeneron
01.2018 - 04.2018
  • Responsible for early Phase I-II Global and USA sites
  • Organized and delivered analyzable reports and metrics to the clinical study trial leader
  • Scheduled and coordinated meetings, prepared agendas, presentation materials, and minutes for clinical study team meetings and other study-related meetings
  • Collated data for assessments such as feasibility and site selection and reviewed site usability database
  • Reviewed study documents such as informed consent forms, and case report forms and facilitates study document reviews per company standard operating procedures
  • Compiled study manuals including but not limited to study reference binders and manuals and maintain versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders)
  • Tracked site activation, enrollment, and monitoring visits, following the monitoring plan
  • In addition, escalated any issues or delays to the clinical study trial leader and CRO
  • Reviewed Monitoring Visit Reports (MVRs) and generated queries for resolution
  • Monitored and updated investigator/site status for the trial and supports with clinical trial registry postings
  • Performed scheduled reconciliations of study Trial Master File (TMF) per specific protocols
  • Reviewed, compared, and created a Confidential Disclosure Agreement (CDA), per site-specific needs
  • Processed and tracked all Investigational Products (IP)
  • Created tracking for all tasks provided by the clinical study trial leader
  • Ensured scheduled reports are received (i.e., 1572 reportable changes, financial disclosure form)
  • Managed and contributed to oversight of Third-Party Vendors (TPV)
  • Tracked and monitored close-out activities – study close-out documents (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and CRA close-out visits
  • Assist in accomplishing department and corporate objectives
  • Other duties as assigned.

Clinical Expert Manager

Novartis
07.2017 - 09.2017
  • Responsible for all operational aspects of 1 or more OGD clinical trial(s) under the leadership of the Clinical Trial Head (CTH)
  • Support all scientific aspects of a clinical trial(s) as assigned
  • Responsible for program-level activities as assigned
  • Assisted Clinical Trial Head (CTH) with specific operational trial deliverables, per meeting timeline deliverables
  • Provided input and contribute to the development of protocol synopsis, investigator brochures, pharmacy manuals, and other related clinical documents; by adhering to departmental procedures
  • Prepared clinical outsourcing specifications for Contract Research Organizations (CROs) and ensure adherence to the scope of work within timelines and budget
  • Vendor oversight of Trial Master File (TMF) regulatory documents for initiation and follow-up
  • Managed interactions and development operations with physicians to ensure IP Drug Supply Management and Novartis local medical organizations
  • Accountable for the accuracy of trial information in all trial databases and tracking systems
  • Accountable for medical writing deliverable quality and ensures work on assigned projects.

Lead Clinical Research Associate

Sanofi US, Inc.
10.2011 - 06.2017
  • Responsible for various Phases II-IV, for multiple protocols (Cardiovascular, Hematology, Neurology, Diabetes, Oncology, Respiratory -Global and USA sites)
  • Managed functionally from 2-12 In-house CRA, per the Lead In-house CRA role
  • Managed 3-5 SSU studies throughout the calendar year, which were high priority studies
  • Managed between 25-60 study sites, conducting study start-up
  • Lead Clinical Research Associate for three priority studies
  • Overview tracking of clinical trial progress through regular documented contact with sites, Regional Site Managers and vendors, and the Sanofi LSF Department
  • Managed to review and approve global consent forms(s), conducted informed consent and template language negotiations with sites and Institutional Review Boards (IRBs), following approved guidelines
  • Liaised with informed consent group as needed for relevant guidance for consent negotiations
  • Coordinated budgetary matters with other departments for clinical trials, including assisting in Negotiate investigator grants, Master Contract Trial Agreements (MCTAs), and Work Orders (WOs), per assigned TA areas
  • Assisted with IP drug and study-related documents
  • Chaired weekly clinical team meetings and work closely with cross-functional teams
  • Work closely with Managers of the SSU department; and provide status of site activity to Clinical Project Leaders, for decision resolution.

Sr. Clinical Research Associate

Merck & Co
04.2009 - 10.2011
  • Reviewed all study start-up regulatory documents, required for drug release following the GCP and SOPs
  • Performed Pre-Study start-up (i.e., continuous contact with the sites, preparing initial regulatory site submissions, and regulatory binders)
  • Assigned as a 2nd Sr
  • CRA reviewer for study start-up regulatory packets, to sign off for the drug release
  • Provided metrics to the clinical study team every week, by keeping track of projects and tasks assigned
  • Responsible for the initial review of Inform Consent Forms and submission to local and central IRBs
  • Managed 15 CRAs global studies (Argentina), to review Monitoring Visit Reports and resolved query resolution
  • In addition, managed 5 Sr
  • CTA to resolve approximately 1500 dosing device discrepancies
  • Responsible for bi-monthly review and QC of Patient Profiles, for Cohort cleaning resolution during a Phase IV study
  • Performed oversight and quality assurance within the INFORM database for TRACER and TRA-2P.

Sr. Clinical Research Associate

Pfizer Inc.
06.2007 - 04.2009
  • Monitored data on an ongoing basis during the study; provides feedback to Director and Associate Director to resolve remediate issues
  • Managed / Liaison with 10 CRAs for domestic USA Sites; to facilitate closing out open queries
  • Responsible for maintenance and forecasting of the study budget
  • Coordinated and negotiated contracts regarding vendor agreements for forecasting of study budget
  • Trained new CTAs on the financial process
  • (i.e., Re-allocation, patient payment, advertisement payment, milestone payment, and study level payment)
  • Generated data queries based on Protocol guidelines
  • Reviewed Case Report Form (CRF) data against source documentation
  • Provided direct support to Study Managers
  • Facilitated ICF review and submissions to IRB
  • Reviewed and submitted all Investigator Initiated Package (IIP) documents for regulatory and drug release
  • Reviewed protocols with inclusion and exclusion criteria, to help with site selection
  • Responsible for FDA preparation and Audit clarification for all regulatory documents
  • Co-responsible with assigned Study Manager to directly managed CRO and vendor activities (ELARA, RightTrack2, EKG Labs, etc.)
  • Responsible for reconciliation of grant documentation for clinical trial agreements and vendor agreements to ensure timely delivery of site payment
  • Reviewed source data verification, in addition to Serious Adverse Event
  • Participated in vendor selection, based on CROs and PCOs
  • Itemized and captured site project status for various spreadsheets on a daily to weekly basis
  • Experience with writing and QC of clinical study reports
  • Participated in patient recruitment.

Lead Clinical Trial Associate

Forest Laboratories
12.2006 - 05.2007
  • Supported members of the clinical trial project team (i.e., Director, Assistant Director, Clinical Scientist I and II) to facilitate the management of pre-approval and post-approval clinical trial process design data queries requested by the team
  • Responsible for site payments, tracking the following: device inventory, patient follow-up schedule, and visit status
  • Coordinated subject enrollment-tracking system and prepared reports for a project management team
  • Maintained and tracked recruitment materials.

Clinical Research Associate

ICON Clinical Research
06.2006 - 12.2006
  • Responsible for Phase II-IV Vaccine for various sponsor companies; including pre-study start-up and drug release approval
  • Responsible for 2-3 protocols with 30-50 sites
  • All site approvals for the regulatory and drug release were under the 5-week deadline
  • Provide a review of Inform Consent Forms and submission to local and central IRBs
  • In addition, ensuring all subsequent challenges from IRB were tracked and provided to legal for approval
  • Conducted contact with the sites for specific requests (i.e., Trial Master Files, CRF Files, and Monitoring Files)
  • Responsible for FDA preparation and Audit clarification for all regulatory documents
  • Maintained contact with the sites for specific requests (i.e., incomplete regulatory documents, missing documentation, data queries).

Clinical Study Associate

Covance Inc.
02.2006 - 06.2006
  • Provided clinical research support and assistance in overseeing the conduct of the clinical trial
  • Collected SAE reports and protocol inquiries; in addition to answering assigned iPledge Clin Project Line
  • Responsible for the resolution of data and SAE queries
  • Ensured sites understood all safety measures of the study
  • Ensured the trials adhering to study protocols, applicable SOPs, FDA regulations, International Conference for Harmonization/Good Clinical Practice guidelines, and government regulations.

Clinical Research Associate

Pfizer Inc.
10.2004 - 02.2006
  • Responsible for all study start-up maintenance and close-out activities for multiple therapeutic areas for Phase IIIb-IV studies
  • Performed all drug request orders for active studies
  • Reviewed clinical supply section of CSR to accuracy
  • Assisted with Cost Estimates and Financial Tracking
  • Maintained all drug supplies and delivery verification to all depots, CROs, and investigator sites
  • Managed between twenty-five study sites, conducting study start-up through close-out activities related to in-house monitoring activities
  • Managed all ancillary Supplies
  • Registered studies within ClinTrials.gov
  • Overview tracking of clinical trial progress through regular documented contact with sites.

Clinical Site Coordinator

Cornell University Medical Center
01.2004 - 07.2004
  • Managed twenty subjects for the Phase III study
  • Maintained patient visit schedules and conducted patients' assessments
  • Liaised between the CRO, local IRB, and Sponsor
  • Co-monitored with CRO.

Sr. Clinical Research Coordinator

Pfizer Inc.
08.1999 - 01.2004
  • Supported the Director and Sr
  • Clinical Project Manager on a Phase IV study involving Infectious Diseases (fungal infections Global and USA sites only)
  • Participated in vendor selection, based on Vendors and CROs
  • Patient Recruitment experience
  • Co-monitored twenty sites with the Sr
  • Clinical Project Manager in the location of NYC and NJ
  • Review Patient Profiles for Infectious Disease study (per elevated vitals) discrepancy
  • Managed SAE and SSAE to all assigned Clinicians; based on therapeutic area
  • Registered studies within ClinTrials.gov.

Sr. Clinical Research Coordinator

Pfizer Inc.
08.1999 - 01.2004
  • Supported the Director and Sr
  • Clinical Project Manager on a Phase IV study involving Infectious Diseases (fungal infections Global and USA sites only)
  • Participated in vendor selection, based on Vendors and CROs
  • Patient Recruitment experience
  • Co-monitored twenty sites with the Sr
  • Clinical Project Manager in the location of NYC and NJ
  • Review Patient Profiles for Infectious Disease study (per elevated vitals) discrepancy
  • Managed SAE and SSAE to all assigned Clinicians; based on therapeutic area
  • Registered studies within ClinTrials.gov.

Education

MBA - Marriage And Family Therapy

Northcentral University
Online
10.2026

BS Degree Health Management -

Kaplan University
05.2007

Skills

  • Biostatistics
  • Project Coordination
  • GCP Knowledge
  • Budget Management
  • Problem Solving
  • Clinical Trial Management
  • Data Analysis
  • Vendor Management
  • Ethics Committee Submissions
  • Site Monitoring
  • Decision Making
  • Medical Writing
  • Protocol Development
  • Study Design
  • Interpersonal Skills
  • Quality Assurance
  • Team Leadership
  • Clinical Data Management
  • Clinical Research
  • Investigator Relations
  • Attention to Detail
  • Time Management
  • Pharmacovigilance
  • Conflict Resolution
  • Adverse Event Reporting
  • Patient Recruitment
  • Regulatory Compliance
  • Organizational Skills
  • Protocol Review
  • Trial Management
  • Clinical Trial Expertise
  • Research Experience
  • Records Management
  • Medication Dispensing
  • Documentation Requirements
  • Informed Consent
  • Good Clinical Practices
  • Specimen Collections
  • Research SOPs Understanding
  • Disease Research
  • Specimen Handling
  • Study Protocols

Core Therapeutic Area

  • Oncology
  • Central Nervous System (CNS)
  • Prostate
  • Emergency Medicine
  • Gastroenterology
  • Neurology
  • Infectious Disease
  • Pediatric Medicine
  • Cardiology
  • Psychiatry/Psychology
  • Dermatology
  • Hematology
  • Diabetes
  • Respiratory
  • Cardiovascular
  • CAR-T

Clinical Trial Management Experience

(I-IV), True, 5, 5, 10, True, True, True, True, 10, True, True, NetMeeting, MS Teams, Zoom, True, MS office professional (Word, Excel, PowerPoint, Access, Outlook), MS Project, MAC Oracle clinical, ELARA, RightTrack2, INFORM, SYNC, eDossier, IMPACT, Grants Manager, Pegasus, Clintrial.gov, Covance Lablink, IVRS, SELFS and CSAMs, NEXTS, ClubNet, APPIAN, CREDI, CinAdmin, CTP, Oracle, Veeva Vault, OTIS, ENNOV, AX 365 Dynamics, CONGA, MS Teams, SharePoint

Professional Overview

Twenty-six years of Sr. Clinical Project Management, Sr. Clinical Research Associate, and Study Start-up, Field Based CRAs Lead experience. Therefore, I am excited to move within the next years to continue my therapeutic growth within the area of (CNS, Respiratory, Diabetes, Infectious Disease, and Oncology). Within the therapeutic areas of (Infectious disease, CNS, Neurology, and Diabetes), I have established 10 years of Project Management and Study Start-Up experience, related to phases from II-IV, which help developed constructive communication between site management, vendor, and sponsor deliverables. Within the therapeutic areas of (Neurology Cardiovascular, Hematology, Diabetes, Respiratory, and Oncology); I have managed over 80 clinical sites as an in-house Clinical Research Associate, within 6 years. By providing quality expertise from study start-up through close-out activities. In conjunction, I have shortened timelines by mentoring clinical research associate counterparts. Delivers upon improvement/innovation projects for the department (subset) of NACO and/or as part of a global team and as aligned to a business case, goals &/or future aspirations. Prioritized a Phase IIIb study, while completing activation within 6 weeks for twenty clinical sites, which resulted in early deliverables results. The results of this provided early deliverables, which helped my department, save over 1 million dollars. Relating to the area of Infectious Disease, I have managed 800 queries to be resolved and cleaned within 3 months, for patient profiles and cohort resolutions during a phase IV study. In addition, I have also managed 15 regional monitors for a global study, to review monitoring reports and resolve 1500 dosing queries within 6 months. Managed all revisions for the full and final process of a Clinical Study Report. Managed two high-profile studies within the therapeutic area of cardiovascular, by ensuring the overall TMF quality of regulatory documents. Within the therapeutic area of Diabetes and CNS, I was able to collaborate and developed faster deliverables for site activation between two departments, related to budgets and study start-up activities, which resulted in having organized communication and a refined escalation process. Oversaw globally within Oncology (4) indications, to process and track all IP Drug Supply Management and Novartis Oncologist organizations.

Timeline

Clinical Study Lead

Novo Nordisk
02.2023 - Current

Project Manager II

OncoBay Clinical Research
10.2021 - 09.2022

Sr. Clinical Development Manager

Novartis
01.2019 - 05.2021

Lead Clinical Research Associate

Ortho Clinical Diagnostics
06.2018 - 11.2018

Clinical Study Specialist

Regeneron
01.2018 - 04.2018

Clinical Expert Manager

Novartis
07.2017 - 09.2017

Lead Clinical Research Associate

Sanofi US, Inc.
10.2011 - 06.2017

Sr. Clinical Research Associate

Merck & Co
04.2009 - 10.2011

Sr. Clinical Research Associate

Pfizer Inc.
06.2007 - 04.2009

Lead Clinical Trial Associate

Forest Laboratories
12.2006 - 05.2007

Clinical Research Associate

ICON Clinical Research
06.2006 - 12.2006

Clinical Study Associate

Covance Inc.
02.2006 - 06.2006

Clinical Research Associate

Pfizer Inc.
10.2004 - 02.2006

Clinical Site Coordinator

Cornell University Medical Center
01.2004 - 07.2004

Sr. Clinical Research Coordinator

Pfizer Inc.
08.1999 - 01.2004

Sr. Clinical Research Coordinator

Pfizer Inc.
08.1999 - 01.2004

MBA - Marriage And Family Therapy

Northcentral University

BS Degree Health Management -

Kaplan University

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Tamika Thomas