Global clinical trial manager/ project manager for multiple oncology/hematology studies.
• Managed study project conduct across multi-functional teams.
• Monitored study related data and metrics to ensure compliance and data integrity across clinical trial.
• Managed study budgets and vendor contracts.
Global clinical trial manager/ project manager for multiple oncology/hematology studies.
- Clinical Trial Manager at Novella Clinical
- Senior CRA at Parexel, Inc
- Principal CRA at PPD, Inc
- Sr. Clinical Research Consultant at Execupharm Inc
2 years, 2 months at this Job
- B.A. - Statistics
- A.S. - Medical Technology
Novella Clinical, Morrisville, NC 2016-2017 Provided day-to-day leadership and guidance to clinical team for assigned project. Responsible for leading team to meet clinical deliverables. Interact with sponsor and cross-functional team members Senior Clinical Trial Manager
• Manage project milestones and proactively address deficiencies.
• Coordinate and oversee daily operation of clinical monitoring team.
• Manage CRA performance.
• Manage and interface with third parties.
• Ensure the clinical trial management system is current
Novella Clinical, Morrisville, NC 2016-2017
Provided day-to-day leadership and guidance to clinical team for assigned project. Responsible for leading team to meet clinical deliverables. Interact with sponsor and cross-functional team members
Senior Clinical Trial Manager
- Senior Clinical Trial Manager at Novella Clinical
- Global Clinical Trial Manager assigned to Amgen at ICON/DOCS
- Clinical Trial Manager at Novella Clinical
- Senior Clinical Project Manager at TKL Research
1 year, 2 months at this Job
- M.A.S. - Management
- B.S. - Biology
Manage clinical deliverables for two Phase III studies in Chronic Lymphocytic Leukemia consisting of 48 US and 5 Canadian sites on one study and 28 US sites on the other study.
Accountable for achieving the final clinical deliverable within the time specified in the contract with the customer, ensuring that all clinical deliverables meet the customer's time/quality/cost expectations. Maintain profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team.
• Manage all clinical operational and quality aspects of allocated studies, in compliance with ICH GCP.
• Develop clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan.
• Contribute to the development of the Master Action Plan (MAP) for providing clinical related documents.
• Ensure timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central).
• Participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required.
• Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
• Collaborate with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicates with the team and leads team meetings to ensure that timelines, resources, interactions, and quality are maintained.
• Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies.
• Responsible for the timely archiving of documents and study materials for the department.
• Ensure achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution.
• Continuous monitoring or co-monitors clinical trials to assess performance and ensure contractual obligations are met.
• Communicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues, as needed.
• Coordinate all start-up activities and ensure that timely ethics committee deliverables are met.
- Clinical Trial Manager at PPD
- Principal CRA at PPD
- Regional Site Manager at Execupharm
- at CSG Inc
1 year, 1 month at this Job
- B.S. - Medical Technology
Clinical Trial Manager Reporting directly to the Vice President of Clinical Development and Regulatory Affairs to support clinical trial writing, site management, timely payments, and regulatory oversite of Phase I and II clinical trials. Study Planning and Conduct Support Provide Administrative Infrastructure to Research Programs
• Set-up and management of ClinicalTrials.gov
• Participate in eCRF User Acceptance Testing (UAT)
• Assist in preparation of clinical trial documents/study protocols/amendments /ICFs
• Monitors/Facilitate/Track IRB submissions and Renewal Applications
• Review and approval of site regulatory package for release of clinical supply
• Ensure site study supplies (Non-IP, Lab Kits, Manuals, etc.) are adequate for trial conduct
• Study startup timeline tracking
• Setup, Maintain, and review of the Trial Master File (TMF)
• Interacts with vendors, investigators, monitors and other external partners
• Implement, review, update study trackers
• Assist in review of data, and progress of EDC entry
• Review and route monitoring reports
• Ensure compliance of GCP guidelines, regulations, and company SOPs
• Provide trial monitor/project manager support
• Track and produce payment approvals for sites and vendors
Clinical Trial Manager
Reporting directly to the Vice President of Clinical Development and Regulatory Affairs to support clinical trial writing, site management, timely payments, and regulatory oversite of Phase I and II clinical trials.
Study Planning and Conduct Support
Provide Administrative Infrastructure to Research Programs
- Clinical Trial Manager at COUR Pharmaceuticals, LLC (Company change direction of focus back to preclinical)
- REGULATORY SPECIALIST at Winship Cancer Institute
- Project Associate at IND 2 Results (Company dissolved during employment)
- ENDOCRINE CLINICAL RESEARCH COORDINATOR at Atlanta Research & Education Foundation
1 year, 5 months at this Job
- - Certified Medical Assistant
•Managed Phase I-IV US and Global investigator sponsored trials: Breast, GI, GYN, GU, HEME, Thoracic and HIV.
•Act as primary liaison for CRO and clinical sites ensuring accuracy for project launch, data base locks and study closeout.
•Tracked trial metrics for patient accruals, Study Specific Training (PI), CRF's, drug planning and Trial Master Files.
•Identified and resolved site and sponsor related issues with ClinOps Team including site pay outs and data queries.
•Entered new study information into various systems: CTMS Medidata, Salesforce, iKnowMed, Florence and EDC.
•Maintained department manuals, forms, documents, and reference materials for study related purposes.
•Reviewed raw data and sponsors questionnaire for protocol execution while identifying sites for feasibility opportunities.
•Approved new protocol amendments, ICF's and study materials for IRB approval.
•Conducted protocol meetings with Site Research Leaders, Principal Investigators and study clinical staff negotiating budgets/contracts, SOC and patient accrual eligibility.
•Managed clinic trials overseeing interdisciplinary clinical research programs ensuring compliance with Good Clinical Practices (GCPs), relevant Standard Operating Procedures (SOPs) and IRB regulatory requirements.
•Lead clinical trials accordingly ensuring quality, timelines and budget management were aligned.
•Accountable for all project deliverables including generated progress reports supporting program trial management.
•Developed contingency planning and risk mitigation strategies to ensure successful delivery of project goals.
•Educated study teams including; Regulatory, Finance, CTA's, CRO Study Sponsors, Budget and Legal on trial process.
•Recommended suitable sites for final trial participation from feasibility based on PI's past accrual target and milestones.
•Responsible for team and clinical trial deliverables while managing project scheduled timelines of PSV's and IM's.
•Worked with QA management team preventing CAPA actions from FDA due to trial deviations consenting issues.
•Act as overseer for recruiting new patients for the Gynecological Cancer Committee of Principal Investigators.
- Clinical Trial Manager at McKesson US Oncology
- Regulatory Coordinator, Clinical Research at McKesson US Oncology
- Patient Recruitment Coordinator at Non-Profit HIV Clinic
- Sr. Pharmaceutical Representative at Medimix Compounding Pharmacy
1 year, 1 month at this Job
- Doctor of Public Health - (DrPH) Epidemiological Research
- MBA - Business Management
- Master of Liberal Arts - (MLA) Journalism (Scholarship Awarded)
- Bachelor of Science - (B.S.) Biology
Research and Development Responsibilities Provided leadership and scientific management for a start-up biopharmaceutical company. Managed and oversaw global clinical program in gastroenterology, CROs, other selected vendors and consultants. Served as the global clinical trial manager for a phase 3 clinical trial involving multiple regions including US, Canada, Eastern Europe and Asia Pacific. Achievements
• Created or assisted in the development of essential study documents (protocol, investigator's brochure, case report forms, informed consent forms, study training and reference materials etc). Successfully optimized the clinical trial design and protocol for maximizing enrollment efficiency and minimizing protocol deviations.
• Successfully led the CRO selection process from creating RFP (request for proposal) documents, to reviewing proposals, conducting bid defense meetings and selecting CRO and other study vendors. Successfully received competitive bids from world's largest CROs. Managed to reduce the original proposed cost by 30%.
• Developed a project management plan in MS Project to track project schedule and timeline.
• Assisted in the development of sponsor SOPs for the conduct of clinical trials and established a trial master file on sponsor side.
• Identified study related KPIs (key Performance Indicators), KQIs (Key Quality indicators) and key risks and developed plans and processes to track them.
• Oversaw the conduct of feasibility study and global site selection process.
Research and Development
Provided leadership and scientific management for a start-up biopharmaceutical company. Managed and oversaw global clinical program in gastroenterology, CROs, other selected vendors and consultants. Served as the global clinical trial manager for a phase 3 clinical trial involving multiple regions including US, Canada, Eastern Europe and Asia Pacific.
- Senior Scientist & Global Clinical Trial Manager at Cristcot
- Senior Research Project Manager & Program Manager at Brigham & Women's Hospital
- Clinical Research Director and Manager at SC Nephrology and Hypertension Center, Inc
- Neuroscience Clinical Research Manager at ActivMed Practices & Research Inc
9 months at this Job
- MPH - Health Services Management and Policy
- Clinical Trial Manager at BARC USA
- Emergency Medical Technician at CrowdRX
- Clinical Research Associate at CityMD
- Health Director at Oasis Children Services
8 months at this Job
- Master's - Healthcare Informatics
- B.A. - Psychology-Neuroscience
• Key responsibilities include:
• Lead cross-functional team with regards to study activities and risk mitigation
• Manage CROs and multiple other external vendors to support clinical studies, develops and revises scope of service agreements, budgets, plans, and detailed timelines as necessary
• Work directly with Central IRBs regarding protocol review, response to the IRB's feedback.
• Support Study Specific Trial Master File by filing and maintaining the electronic trial master file (eTMF) and maintain audit ready clinical trials documentation.
• Works closely with Finance Department to review and process invoices.
• Independently oversee study activities, including: engagement of investigators, study start-up activities including site initiation, study monitoring activities, data collection and close-out activities
• Provide oversight of the CRO to ensure compliance with Merrimack's quality measures
• Develop and manage comprehensive study timelines and metrics and ensures completion of study deliverables
• Oversight of trial budget and vendor contracts
• Contribute to the development of study related documents (contracts, ICFs, protocols, IBs, SOPs, etc.)
• Participate in development of CRFs, including User Acceptance Testing
• Manage and communicate study enrollment projections
• Address and escalate relevant operational issues to key stakeholders
- Senior Clinical Trial Manager at Merrimack Pharmaceuticals, Inc
- Consultant at Independent Clinical Research
- IRB Chair, Tuesday Board at New England Institutional Review Board
- Manager, Clinical Research/Compliance Officer (Consultant) at Solace Therapeutics
2 years, 5 months at this Job
- Bachelor of Science - Health Information Management
- - Minimal Access Surgery and Technology
Late Phase Clinical Operations)
• Leads the execution of trials for the research team
• Planning and tracking of all clinical activity in the lifecycle phases of the startup, interim and close out
• Educates Research Nurses and clinic staff on protocol modifications and specifications including visit schedule, assessment windows, dose modifications, central and local laboratory assessments
• Ensures pharmacist has clinical and drug supplies and interfaces with laboratory staff for lab kits
• Participates in monitor visits monthly, on average, for each trial assigned
• Assists sponsor and US FDA audit teams and reviews and responds to associated findings
• Initiate improvements to enhance both efficiency and quality of the work performed on assigned projects
• Assist to ensure physician oversight by updating on protocol issues prior to updating the sponsor and obtaining signatures and clinical significance of laboratory reports, ECGs, and adverse events
• Sponsor interaction including daily phones calls to update on patient status, toxicity and response
• Participant in weekly teleconferences with sponsors to update on patient status, toxicity and response
- Clinical Trial Manager at Sarah Cannon Research Institute
- Clinical Data Coordinator at Sarah Cannon Research Institute
- Internship at St. Bernards Medical Center
- Registrar Imaging Center/Emergency Room at EMR Meditech filing
3 months at this Job
- Bachelor of Science in Health Studies - Health Studies
• Oversights the execution and management of day to day activities of clinical operation for regional and global studies from study start up to close out
• Achieved database lock 30 days ahead of scheduled timeline for global phase 3 study
• Contributes to operational and strategic input of study documents such as ICF, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plan, Clinical Database edit specifications, Monitoring Plan,Clinical Study Report (CSR) development, TMF plan & Index etc
• Responsible for oversight management of clinical monitoring quality and ensure adherence to processes and plans in adherence to protocols and applicable SOPs
• Perform Oversight of 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
• Responsible for managing and coordinating start up activities for global phase IIIB basket protocol study
• Monitoring trial progress to ensure compliance with and adherence to the project plan and to identify, evaluate and rectify problems
• Management of multiple vendors (centre lab, specialty lab, IVRS) and CROs activities and tracks project deliverables within the timeline and budget
• Facilitation of country and site feasibility/selection processes with use of robust data and ensures appropriate site feasibility documentation is filed in the Trial Master File (TMF)
• Review protocol deviation/violation to ensure appropriate deviation codes are utilised
• Perform clinical data review of data listings and summary tables, including query generation
• Participation in Serious Adverse Event (SAE) reconciliation process
• Oversight country regulatory authority (e.g. CTA, MoH) and country/site IRB/IEC approvals/notifications
• Management of the trial budget(s) and maintenance of the accounts
• Responsible for coordination of training for study team, investigational sites and vendors
• Facillitates/review of contracts, project estimate costs and track payments for operational aspects of the study in collaboration with the Purchasing department
• Management of the trial budget and account and review/approval of vendor invoices after reconciliation with executed contract, manage of accruals and scope of work changes (SOW)
• Development of the subject recruitment/retention strategy and related initiatives
• Oversight of investigational product supply forecasting/management and study-level IP reconciliation in collaboration with IMSC and recommend appropriate trade-off to balance risks and study execution deliverables
- Senior Clinical Trial Manager at Celgene Corporation
- Clinical Trial Manager at Allergan Inc Pharmaceutical Company, Jersey City
- Expert Clinical Manager at Novartis Pharmaceuticals Corporation
- Clinical Research Associate at Clintec International Inc
1 year, 8 months at this Job
- Bachelor of Science - Nursing
- Bachelors of Science - Agricultural