Michelle Goldsborough
Wimauma,FL
Summary
Experienced Senior Clinical Project Manager with over 18 years of experience in clinical operations management, specializing in Oncology including Car-T studies, Basket Trials, Vaccines and Rare Disease. Additionally, I am experienced in Lugano classification, Deauville scoring, Ann Arbor staging and RECIST classification.
Overview
32
32
years of professional experience
1
1
Certification
Work History
Sr. Project Manager
Industry Consultant Sponsors and CRO’s
08.2016 - Current
- Sponsors and CRO’s:
- Abbvie Pharmaceutical Co. February 2023 – Present
- ProPharma Group September 2023 – Present
- Alexion/Astrazeneca September 2020 – September 2023
- American Regent September 2019– September 2020
- Ipsen Pharmaceutical Co. September 2022 – February 2023
- Pfizer September 2021 -September 2022
- IQVIA February 2020 – September 2021
- Shire acquired by Takeda August 2019 – February 2020
- Covance acquired by LabCorp/PPD September 2018 -August 2019
- SYNEOS July 2016 – September 2018
- Parexel August 2014- July 2016
- Jazz Pharmaceutical Company May 2013 – August 2016
- Oversight and Management of global Clinical Trials across multiple phases of development including CRO and vendor management.
- Facilitate monthly Stage Gate meetings with Sr. Management to discuss status of studies.
- Work with Medical Monitor and Clinical Operations team to draft study design using the study schema.
- Attend departmental meetings with functional leads as needed.
- Draft and manage program level clinical operations budgets and site budgets.
- Assure GCP compliance with regulatory requirements and internal company procedures and processes for inspection readiness, including but not limited to the planning, conduct, and reporting of external vendor audits, Trial Master File audits, clinical investigator site audits, document audits, and system audits.
- Draft and review SOP’s and Work Instruction documents.
- Conduct audits on inhouse eTMF and CRO’s eTMF.
- Draft reports regarding audit findings from the eTMF.
- Direct functional leads on using e-Clinical Solutions and Digital Product Solutions.
- Manage eCOA devices understanding country laws and preferences, guide team regarding same.
- Draft Informed Consents and Informed Assents.
- Conduct weekly and or Bi-Weekly Clinical Team Meetings including drafting functional team updates, vendor updates.
- Draft and revised meeting minutes as needed.
- Draft study plans and contribute to functional team study plans.
- Draft Protocol Exception Memo and Protocol Clarification Memo’s.
- Work with Data Management to ensure that the unique pages reflect the protocol.
- Train CRA’s, CTA’s and functional leads on the protocol
- Conduct BID Defense meetings for CRO’s and e-Pro and e-Consent vendors. Evaluate same using Score Cards.
- Monitor Medidata or Inform database to ensure that patients have received their treatment and are not experiencing G3 or above AE’s.
- Draft and review protocol deviation reports.
- Work directly with legal, compliance and privacy departments regarding study conduct.
- Ensure that IP is distributed to sites in a timely manner.
- Perform root cause analysis for issues related to the conduct of the study.
Sr. Procurement Manager (Consultant)
Ipsen Pharmaceutical Company
02.2023 - 02.2024
- Oversee Epizyme Acquisition and work with functional leads during transition
- Draft and negotiate Master Services Agreements, Change Orders, Work Orders, Authorizations to Proceed, Consultant Agreements
- Work directly as a liaison between Clinical Project Managers and Clinical Project Directors to review CRO scope of work and any Change In Scopes and Change Orders
- Ensure that team is using the preferred vendor list
- Draft and review Purchase Orders
- Work as a liaison between Clinical Operations, Legal and the vendor and/or CRO’s to ensure that performance issues are addressed
- Ensure that services are Fair Market Value
- Draft and review contracts as needed
- Review Clinical Protocols and work with the Clinical Operations team to ensure that CDA’s are in place for vendors
- Work Directly with Executive Directors to ensure procurement savings are documented.
- Attend Clinical Trial Meetings
Sr. Clinical Project Manager
Imago Bioscience acquired by Merck
10.2022 - 02.2023
- Operations and Teams
- Develops and maintains effective working relationships with team members, with particular focus on external CRO study teams.
- Ensures that study team members (e.g., CRO and/or CRAs) are aware of their specific area of responsibility, contribution to and participation in study teams.
- Maintains awareness of best practices to ensure study teams are aware of risks, priorities, value and impact of their work and contributions.
- Timelines, Resource, Budget, Risk, Quality
- Ensure all operational tracking needs are identified, including systems and tools to meet timelines and the needs of the study team and facilitate reporting to Clinical Management & external business partners.
- Assists with the development and review of SOPs.
- Provides operational input into and assists with the execution of study level audit plans, quality, risk management and contingency plans.
- Ensures completion of any corrective action plans resulting from site audits.
- Assists in calculation and forecasts of study drug requirements and development of drug supply chain process.
- Operational Elements
- Communicate the study(s) status regularly with Imago team and external CRO(s) and escalates unresolved issues appropriately to Clinical Management.
- Make recommendations to the Imago team for strategic country and site distribution and patient numbers. Finalizes site selection in consultation with the Imago team.
- Provides operational input or takes direct responsibility for producing core study documents including protocol, informed consent, eCRF, SOM, pharmacy manual, forms and templates.
- Oversee the collation of feedback on study level documentation from the Imago team and external teams as appropriate; ensuring appropriate updates are made.
- Updates operational timelines as appropriate.
- Organizes Investigator Meetings, CRA trainings, CRO kick-off meetings, Nurse training events.
- Contributes to the presentation documentation on operational aspects of the study.
- Reviews and manages variances between actual and forecasted spend for contracts within their responsibility.
- Approves and signs off on study-related invoices for contracts within their responsibility.
- Pro-actively manages actual recruitment vs planned patient recruitment.
- Serves as the primary contact with CRO teams to maintain oversight of overall performance, work to proactively identify issues and manage their prevention or timely resolution.
- Assists with ordering, shipment and return of study drug and other clinical supplies to/from clinical sites.
- Coordinates responses to questions or concerns from Competent Authorities or IRBs/ECs.
- Day to Day Operational Management of CROs and Vendors
- Provides operational input into the selection of CRO partners and vendors.
- Leads the development, review and finalization of the scope of work.
- Primary day-to-day contact for operational related activities where appropriate.
- Ensures delivery against contracted scope of work.
- Oversees reconciliation of invoices against scope of work and completed activities.
- Best Practices and Process Improvements
- Pro-actively incorporates learnings and recommendations from past experience and best practices into current processes; works with company-wide project management to ensure consistent cross Imago practices.
- Ensures GCP regulations and SOPs are adhered to within the operational team.
- Liaises with Imago and CRO teams to identify systematic issues arising across the study(s) and coordinates any corrective actions.
- Supervisory Responsibilities
- Serve as direct line manager of Sr./CTAs, and Sr./CRAs
- Oversee and manage work of Clinical Operations contractors, consultants and CRO/vendor team members.
Clinical Contracts/Start-Up Manager
Celeritas Solutions LLP
04.2014 - 08.2016
- Oncology (Phase I, II and III / Rare Disease)
- Assigned to ProQr Therapeutics, Amicus Therapeutics.
- Managed Oncology, Rare Disease and Cystic Fibrosis Phase I to Phase IV studies.
- Worked with functional leads to ensure the adherence to timelines.
- Drafted and negotiated Clinical Trial Agreements, Confidentiality Non-Disclosure Agreements, Work Orders, Authorizations to Proceed Agreements, Start-Up Agreements, Change Orders, Amendments, Lexicon Agreements, and Consultation Agreements.
- Trained study team on SOPs, and Protocols.
- Trained CRAs and approved monitoring visit reports.
- Developed relationships with investigators and site staff.
- Presented at Investigator Meetings.
- Drafted SOPs and sections of the Clinical Study Report.
- Reviewed RFPs and selected Vendors.
- Ensured compliance with international GCP guidelines/ regulations and SOPs.
- Participated in quality assurance activities and coordinated resolution of audit findings.
- Ensured audit-ready condition of clinical trial documentation including central clinical files.
- Coordinated and assisted in the planning of regulatory and ethics committee activities.
- Reviewed clinical study data listings and assessed the impact of this data to the clinical program.
- Ensured Study Closeout.
- Managed timelines.
Senior Clinical Study Manager /Start-Up
ONO Pharma USA, Inc.
06.2011 - 06.2014
- Hematology/Oncology/Multiple Myeloma – Phases I – III (Infectious Disease)
- Managed Oncology and Infectious Disease Studies- Various Indications.
- Drafted and negotiated CTA’s and budgets, MSA, Work Orders, Change Orders, Authorizations to Proceed, Employment Agreements, Lexicon Agreements, Consultation Agreements
- Led cross-functional study team, developed, managed, and maintained study timelines, minutes, budget and tracking, training materials and coordinated training on study procedures.
- Developed study management plans and study specific working practices.
- Developed study execution plans, communication plans, risk management plans, and project plans.
- BLA and MAA preparation in collaboration with regulatory affairs.
- Reviewed and commented on synopsis, protocol, ICF and CRFs, developed overall study budgets, recommended number of investigative sites, oversaw the development of investigational product supply forecasting and management, provided input on project specifications and feedback on requirements for CTMS, guided structure and oversaw set up TMF.
- Led and participated in regulatory BLA and MAA submissions.
- Participated in country selection, in collaboration with CRP and CRS, identified prospective investigative sites, created feasibility questionnaires, participated in final investigative sites selection, developed and monitored investigative site budgets and oversaw negotiation of financial terms of individual site budgets, managed site payments and monitored GCP ICH site-level compliance.
- Participated in preparation of RFP, assumptions and SOW, recommended vendors, contributed and reviewed specs for vendors (IVRS, Labs), managed vendor oversight, reviewed and approved vendor invoices.
- Reviewed patient outcomes and quality of life data.
- Reviewed essential regulatory documents, prepared detailed study timelines, developed, and oversaw risk management plans, prepared, reviewed, and approved Monitoring Plans, assured adherence to Monitoring Plans.
- Created eCRFs and draft edit check plans, reviewed eCRFs specs (EDC) and CRF completion guidelines.
- Implemented RAVE Medidata targeted SDV, designed, reviewed, and approved ICONIC study tools (for investigative site use), created study team contact roles and responsibilities, reviewed DM documents (CRO and in-house studies) and facilitated Development and Reviewed Data Review Plan.
- MFs were current.
- Managed CROs, IVRS, and study vendors.
- Knowledgeable of SAS.
Clinical Project Manager
Glaxo Smith Kline
06.2007 - 06.2011
- Therapeutic Areas: Thrombocytopenia, Solid Tumors, Lymphoma, Oncology (Breast, Lung, and Ovarian Cancer), Hematology, Multiple Sclerosis - Phase I, IB.
- Reported to the Director of Drug Development.
- Responsible for operational management of clinical program conducted by GSK.
- Ensured quality and completeness of SharePoint TMF.
- Provided management of CROs, vendors, timeline development, recruitment, safety, and communication plans development.
- Approved monitoring visit reports, and ICFs.
- Chaired weekly recruitment meetings.
- Determined site selection and qualification, developed monitoring plan.
- Reviewed site feasibility questionnaires.
- Conducted pre-study site visits, and site initiation visits.
- Selected study sites.
- Created and implemented patient recruitment and retention plans.
- Assisted the Clinical Research Director, Senior Director, and Clinical Research Managers in the implementation of clinical projects by participating in consultant meeting, reviewing protocol synopsis and protocols.
- Managed vendor budgets.
- Reviewed data listings for safety, concomitant medications, adverse events and serious adverse events.
- Reviewed safety profiles created DCFs.
- Wrote patient safety narratives.
- Assisted in locking EDC database.
- Answered investigator questions.
- Primary contact for internal and external teams.
- Developed project tracking systems.
- Developed clinical supply logistics, PK sample handling, and all aspects of program development for U.S. CROs.
- Used MS Project to manage timelines and deliverables.
Senior CRA (Late Phase)
Registrat/Mapi/ICON
06.2003 - 06.2007
- Effectively communicated with the Clinical Trial Manager and Head of Clinical Operations, to ensure the efficient initiation and execution of clinical studies.
- Led/managed assigned sites through regular contact (in-person and via phone/email) to ensure adequate screening/enrollment and understanding of study requirements.
- Trained study site personnel and identified opportunities to improve patient screening and enrollment recruiting activities.
- Led and directed study start up activities including site surveys and qualification visits, and followed up with sites regarding timelines for IRB/EC approvals, budget and contracts.
- Coordinated and attended Initiation Visits with Site Monitor and CMO to provide required training.
- Responsible for tracking and reporting study status to Clinical Trial Manager.
- Supported monitoring and participated in co-monitoring as required to ensure accurate data was entered in in a timely fashion.
- Participated in regular calls and meetings with Clinical Trial Manager and Director of Clinical Operations, and any clinical team calls with CMO and CEO as required.
- Reviewed study documents and SOPs for completeness and clarity.
- Monitored trip reports.
- Trained CRAs on the protocols and subsequent amendments.
- Ensured that the TMF was up to date.
- Supported our business and clinical trial endeavors.
- Planned and implemented activities required to conduct and monitor clinical trials in accordance with protocols, SOPs, GCPs, ICH, and all applicable regulatory requirements.
- Performed all activities of site selection; monitoring/co-monitoring, managing and closing clinical study sites.
- Ensured adherence to study timelines for enrollment and other milestones.
- Participated and presented at study team meetings.
- Updated the TMF and ensured that all documents have been filed.
- CRA (Late Phase)
- Conduct Pre -Site Selection Visits.
- Review protocol and train sites on protocol.
- Draft Monitoring Visit reports.
- Follow-up on site protocol deviations.
- Conduct site training as needed.
- Conduct Monitoring Visits.
- Work Directly with Feasibility.
- Ensure documents in eTMF are ALCOLA compliant.
- Review Medidata Rave to ensure site has entered data in a timely manner.
Contracts and Litigation Paralegal
Morgan Lewis LLP
12.2000 - 06.2003
- Draft first draft of contracts
- Draft Motions, Pleadings, Interrogatories
- Review discovery
- Draft summaries
- Assist with prepping clients for depositions and court proceedings
- Draft meeting minutes
- Conduct legal research
- Perform administrative duties to support attorneys
Litigation Paralegal
Skadden Arps
01.1994 - 12.2000
- Draft Motions, Pleadings, Interrogatories
- Review discovery
- Draft summaries
- Assist with prepping clients for depositions and court proceedings
- Draft meeting minutes
- Conduct legal research
- Perform administrative duties such as docketing, and maintaining calendar to support attorneys
Education
Bachelor of Science - Business Administration
Seoul National University
05-2009
Certified as Expert - undefined
United States Army Advanced Leadership Academy
Fort Gordon, GeorgiaParalegal Program - undefined
Widener University School of Law
Skills
- Project planning
- Scope management
- Client relationship management
- Project plan development
- Project scheduling
Accomplishments
- Collaborated with functional team leads in the development of and conduct of clinical trials Phases I-IV
- Achieved End of Study Closeout by completing numerous tasks from Start-Up to Close-Out with accuracy and efficiency.
- Used Smart Sheets to develop timelines and share same with functional leads.
- Resolved study related issues regarding study conduct with functional leads and Sponsors as needed.
- Identified and mitigated study related issues and through effectively helping with risk identification and mitigation.
- Supervised team of Clinical Trial Assistants and Clinical Research Leads and Associates.
- Work with cross functional leads from Biostatistics, Quality, Trial Master File Managers, Document Managers, Procurement Managers and Contracts and Budget Managers.
- Conducted weekly or bi-weekly Clinical Team Meetings.
Certification
Project Management Certificate
Statistical Process Control
Quality Assurance
LANGUAGE
Fluent in Spanish and English
Conversational French and Creole
Knowledge of Arabic
Timeline
Sr. Procurement Manager (Consultant)
Ipsen Pharmaceutical Company
02.2023 - 02.2024
Sr. Clinical Project Manager
Imago Bioscience acquired by Merck
10.2022 - 02.2023
Sr. Project Manager
Industry Consultant Sponsors and CRO’s
08.2016 - Current
Clinical Contracts/Start-Up Manager
Celeritas Solutions LLP
04.2014 - 08.2016
Senior Clinical Study Manager /Start-Up
ONO Pharma USA, Inc.
06.2011 - 06.2014
Clinical Project Manager
Glaxo Smith Kline
06.2007 - 06.2011
Senior CRA (Late Phase)
Registrat/Mapi/ICON
06.2003 - 06.2007
Contracts and Litigation Paralegal
Morgan Lewis LLP
12.2000 - 06.2003
Litigation Paralegal
Skadden Arps
01.1994 - 12.2000
Certified as Expert - undefined
United States Army Advanced Leadership Academy
Paralegal Program - undefined
Widener University School of Law
Bachelor of Science - Business Administration
Seoul National University
Therapeutic Experience
- Vaccine: Novartis, Covance and also George Clinical (Covid 19 study).
- Oncology: Car-T studies (multiple indications Phases I, II 40 sites 3.0 years), Leukemia (Phase I and II, 43 sites for 2.5 years), T-cell Lymphoma (Phase II, 42 sites for 1.5 years), Lung Cancer (Phase I, 50 sites for 2.0 years), Rare Disease Oncology Neuroendocrine tumors, bladder, kidney, pancreatic and breast cancers (Phases I and II with 35 sites for 2.0 years), Brain Cancer (Phase I and II 54 sites 1.5 years), Ovarian Cancer (Phase I and II 39 sites 1.0 years), Ewing’s Sarcoma (Phase II and III 74 sites 1.5 years), Multiple Myeloma (Phase I and II 55 sites 1.0 year)
- Rare Disease: Pompe Disease (Phase I and Phase II, assigned 15 sites for 1.5 years), Gaucher Disease (Phase II, assigned 17 for 1.5 years), Myasthenia Gravis Disease (Phase 1 assigned for 35 sites for 2 years), Rare Disease Oncology Neuroendocrine tumors, bladder, kidney, pancreatic and breast cancers (Phases I and II with 35 sites for 2.0 years)
- Hematology: Antithrombin Deficiency (Phase I and II 55 sites 1.0 years)
- CNS: Cystic Fibrosis (Phase I and II 55 sites 1.0 year)
- Neurology: Opioid- Buprenorphine (infants) (Phase I, 20 sites 1.0 year), Generalized Anxiety (Phase 1, 30 sites 1.0 year), Essential Tremors (Phases II and III 130 sites 2.5 years), Cerebral Palsy (Phases II and III 280 sites 2.0 years)
- Global Trial Experience: Germany, Europe, United Kingdom, Chez Republic, Argentina, Italy, Australia, France, Saudi Arabia, Africa, Switzerland, China, Philippines, Japan.