The Clinical Trial Manager is responsible for the day to day leadership and management of monitoring services for clinical projects, including direct communication and interaction with investigative sites/monitors/Sponsor. Delivers monitoring services to Project Management.
- Sr. Clinical Trial Manager at Clinipace Worldwide
- at Clinipace Worldwide
- Senior Clinical Research Associate/Lead CRA at Clinipace Worldwide
- Project Manager at Clinipace Worldwide
3 years, 5 months at this Job
- License - Expiration
Several years of oversight of assigned studies in Phases 1-4 clinical trials Excellent interpersonal and communication skills, demonstrates hands on experience, result oriented, with a sense of urgency to meet timelines and solve problems independently and with internal team members. Vendor management, budget management, ensuring that studies are conducted and completed in accordance with SOPs and company goals at large Lead weekly Clinical Trial Team Meetings Extensive experience in CNS and neurology early to late phase studies Extensive experience in CRA systems such as IXRS/IWRS, Infosario, various laboratories, and EDC systems designs and part 11 validation requirements. Expertise in clinical monitoring skills that include conduction of Site qualification/ selection, initiation, monitoring and close out visits of sites assigned. Manage and ensure the accuracy and transparency of local operating budget, including budget cycling, accruals, chargebacks, and transfers. Advices CTM leadership on operating budget matters - Oversees payments to clinical trial investigators through third party supplier. - Oversees verification of investigator financial disclosures, including those related to regulatory filings. Ensures that clinical trial budgets remain on track and aligned with global planning estimates. Continuously monitors and reports on status and expected outcomes. Ensures all clinical trial related SAP transactions are posted appropriately. Leads the coordination and preparation of forecast/budget support and documentation. - Manages SOWs, creates purchase orders, reviews accruals and forecasting responsibility for 3rd party vendors. Directly negotiates contracts with suppliers in accordance with established policies, regarding SOWs, processing invoices and change orders. - Participates in cross functional teams locally/globally to assure timely attainment of project milestones. Impeccable contract/budget negotiations with selected sites to stay on predetermined budget for the project. Thorough understanding of FDA/ICH, GCP, Clinical Safety Data Management, Clinical Trial Management, regulatory compliance & applicable SOPs. Supported study planning activities, developing study time lines (IRB approval), designing CRF, updating Investigational Brochures, planning and conducting investigator meetings. Participate in CRO training and investigators meetings Participates in protocol writing and reviews. Develop the Quality control oversight plan for assigned trials in collaboration with global CTM team Develop trial specific quality control document and training material Good clinical monitoring and report writing skills. Ability to work independently with good organization skills Able to train department team members and participate in investigator's training. Assist principal investigators and internal team member with mitigating and implementing corrective actions after QA and other Health Authority audit. Software: Microsoft Office including Word, Excel, Outlook, PowerPoint and strong internet background; EDC - Devices: Medidata CTMS, INFOSARIO, RAVE, INFORM, IMPACT, E-CLINICALS, DATALAB, ORACLE (ORDC), SUNRISE CLINICAL MANAGER 5.5, CLINPAY, CLEARTRIAL, SAP, FIRSTDOC, RADAR, RASS, SITE HEALTH, SOCs Pro, FIRE CREST, RIGHT TRACKII, CONCUR. Therapeutic Areas: CNS, Respiratory, Cardiology, Psychology, GI, Oncology, Neuroscience, Endocrinology and Metabolic disease, Ophthalmology, Dermatology, Pain management.
- Clinical Trial Manager at Pfizer Inc.
at this Job
- Bachelor of Science - Nursing
- Bachelor of Science - Accounting
• Lead the development, coordination and implementation of monitoring and administrative strategies essential to successful trial management for vaccine studies.
• Act as sponsor Liaison to resolve site related issues quickly and effectively.
• Conduct site pre-qualification and initiation visits, verifying site and staff qualifications.
• Conduct on-site clinical monitoring to include protocol training, document review, ensuring accurate data recording.
• Conduct closeout site visits, including reviewing record retention requirements, investigator product reconciliation and reviewing investigator's final report.
• Verify and ensure rights and well being of human subjects enrolled in the trials are protected.
• Ensure conduct of the trial is in compliance with approved protocol/amendments, with ICH, current GCP, FDA, CFR, USAMRMC, OTSG-DA, DoD and other government regulations.
- Clinical Trial Manager at ICON GPHS
- Senior Clinical Research Associate at Novavax, Inc
- Clinical Trial Manager at Accelovance, Inc
- Safety Consultant at
1 year, 2 months at this Job
- Bachelor of Science in Biology - Biology
- Serves as the key operational contact with external investigators - Establishes strong partnerships with external investigators and collaborators with respect to study management to ensure projects are executed in a timely manner and to high quality - Site recruitment, site initiation, site compliance and close out - Acted as cross-functional liaison with Executive, Operations, Regulatory, Finance and all vendors involved with project - Maintains a good understanding of industry standards for studies and keep abreast of any new changes and developments - Work with study team to ensure quality and all study milestones are achieved on time - Communicating daily with institution based clinical investigators/research staff (patient related safety, budget, data, payments) - Responsible for all aspects of the clinical trial start-up including, identification, evaluation and management of CROs and vendors - Development and management of revisions to study related documents and agreements including: Protocol, Contracts, Budgets, Informed Consents, Study Manuals, Study Worksheets, Recruitment tools and Case Report Forms
- CLINICAL TRIAL MANAGER at QUANTGENE INC.'1
- CLINICAL RESEARCH COORDINATOR at UNIVERSITY OF MIAMI
- DATA COORDINATOR at UNIVERSITY OF MIAMI
- CLINICAL RESEARCH COORDINATOR at EENA COMPREHENSIVE NEUROLOGY AND SLEEP CENTER
1 year at this Job
- B.S. - NEUROSCIENCE AND BEHAVIOR
- - General Chemistry
• Work closely with Project Manager to ensure trial is running efficiently
• Implementing study-specific protocols and monitoring data
• Collecting and reviewing trial data
• Review reports in order to approve or reject data
• Follow up with sites in regards to data errors
• Resolve data errors
• Transform data accordingly
• Utilize Cerner and other study execution programs.
- Clinical Trial Manager at BARC USA
- Emergency Medical Technician at CrowdRX
- Clinical Research Associate at CityMD
- Health Director at Oasis Children Services
3 months at this Job
- B.A. - Psychology-Neuroscience
Manage all aspects of a clinical trial from site initiation to close out visit. Assisting with CRA and third party vendor training on protocols and practices Developing and maintaining good working relationships with investigators and study staff Ensuring studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedure Investigating queries, monitoring discrepancies Managing investigational product (IP) accountability and reconciliation process Performing clinical data review of data listings and summary tables, including query generation Reviewing key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determining appropriate action in conjunction with study team Reviewing or approving of IP release packages Tracking and reporting on progress of study including site activation, patient enrollment, monitoring visits
- Clinical Trial Manager at Medtronics
- Clinical Research Coordinator at Travis Clint O ' Neal
- Front Desk Agent at Sonesta ES Suites
- Contract Recruiter at 3Wire
8 months at this Job
- - Pre-Nursing
- Associate of Science
- - Physical Fitness
• Manage site start up and execution for 1 Israel and 15 North American sites for Phase 2 double-blind placebo-controlled randomized clinical research study
• Manage in house site start up and execution of a Phase 2a, Randomized, Double-Blind, Parallel-Group
• Manage the resolution of any site related issues
• Provide weekly metrics for screening, randomizing, projected recruitment, screen fails, completion
• Manage Fleishman with recruitment for STARS-Angelman study
• Liaise with ICON and Concierge while ensuring that sites receive necessary assistance in providing travel and/or travel reimbursements for family and caregivers
• Liaise with finance regarding Contract Research Organizations (CRO) monthly finance reports; reviewing study actuals, forecasts, and budgets
• Coordinate and manage calls with CROs and vendors
• Work with preclinicial to set-up biomarker studies' vendors, budgets, and logistics
• Oversee and perform User Acceptance Testing for Electronic Data Capture (EDC) and Interactive Web Response System (IWRS)
• Oversee and review Lab Specification, Pre-Study Visits, and Site Initiation Visits documents
• Liaison with regulatory to create necessary instructions for the sites; i.e. PK sample and labeling instructions
• Liaise with multiple vendors to report to the team and provide updates to upper management
• Create Study Workflows for vendors and study trials
• Liaison with legal to get Clinical Trial Agreement (CTA), Clinical Disclosure Agreements (CDA) and contracts written and fully executed appropriately
• Review Scope of Work to ensure desirables are met and budget is acceptable
• Review Informed Consent Forms for initial protocol and amendments
• Review Change Order Forms for out of scope work for all vendors
• Create Summary of Changes for Protocol Amendment
• Create monthly PowerPoint slides with study metrics for upper management
• Arrange site teleconferences with various points in the study; i.e CSI-I scales
• Meet with Key Opinion Leaders to gain information and outlook on study design
• Arrange Kick of Meeting for PPD and Fragile X study
• Coordinate Investigator Meeting
• Ensure sites were posted on clinicaltrials.gov
• Facilitate the decision on questionable raters through Bracket and VP of Clinical Development
• Provide internal medical team with study Adverse Events (AEs) and Serious Adverse Events (SAE)
• Ensure queries are solved before timelines such as Interim Analysis
• Track all protocol deviations
• Travel as necessary to represent company's interest in certain therapeutic areas
• Assist in organizing Investigator Meeting
• Performed Lab reconciliation for database lock
• Present clinical timelines, site status and recruitment strategies at Fragile X Advisory Board Meeting
- Clinical Trial Manager at OVID Therapeutics
- Senior Clinical Trial Associate at Axovant Sciences
- Celgene (Consultant) at Celgene
- Ophthotech (Consultant) at Ophthotech
1 year, 11 months at this Job
- Master of Science in Clinical Research Organization and Management - Clinical Research Organization and Management
- Bachelors in Biological Sciences and Sociology - Biological Sciences and Sociology
- Associates of Arts in Liberal Arts - English, Biology
• Regional Study Management of Clinical Studies (North America)
• Oversight of the operational execution of assigned clinical studies, which includes Trial Master File maintenance and reconciliation
• Assistance in Sponsor and Regulatory/Ethic Committee study and site level audits (FDA, Health Canada)
• Ensure that asinged clinical studies are run to time and budget and is completed in compliance with all relevant laws, regulations, and regulatory guidelines, as well as Allergan policies and procedures
• Collaborate with study Operation Study Lead (Global Study Manager) and cross functional teams to provide support to ensure regional acitvities remain within projected budget and timelines
• Preparing, collecting, and tracking master study level documents
• Review of study and country level Informed Consent Forms (ICF), with translations (Spanish, French, etc.)
• Reviewing, updating, and testing clinical systems - IVRS, eCRF, etc.
• Performing manual reviews of clinical trial data
• Corresponding with trial sites to resolve Specular Microscopy issues (Konan Specular Microscope)
• Supporting Allergan CTMA's and trial RSM's
• Clinical Study Start-up- Budgets, Contracts, Ethic Committee Submission, Study Site Activation
• Creation of Source Documents and study specific forms
• Assistance in study specific training: Equipment training for sites and trial RSM's
• Clinical Trial Management: Regions- United States, Canada, Singapore, Australia, Philippines
• Global Vendor Management: Konan Medical- USA; Canfield Scientific; Covance Laboratories
• Creation and editing of Study Monitoring Plans
• Creation and maintentance of vendor oversight plans
• Study database lock and close-out activities
• Familiarization of study level budgets, projections, and accruals
• CV review, candidate interview, and candidate approval of new progam team members
• Onboarding and training of new project personnel and resources
• Mentorship of study interns and entry level Clinical Trial Management Associates (CTMA)
- Clinical Trial Manager, Global Clinical Trial Management at Allergan, Inc
- Sr. Clinical Trial Management Associate, Global Clinical Trial Management- Ophthalmology at Allergan, Inc
- at Allergan, Inc
- Clinical Research Coordinator, Optometrist Assistant at David T. Wakabayashi, O.D., F.A.A.O
10 months at this Job
- Bachelor of Arts - Psychology
Lead a team of In-House CRAs and field-CRAs throughout clinical trials: feasibility and site selection, start-up, recruitment,
treatment/follow-up and close-out.
• Responsible for resource allocation, timeline adherence, quality assurance, and financial adherence as it pertains to clinical monitoring team activities.
• Create collaborative development plans with direct reports that enhance core competencies and resolve outstanding performance challenges.
• Provide guidance, motivation and mentoring to project team members.
• Interact with line managers to provide feedback on clinical team member performance.
• Recruit, interview, and hire clinical operations staff of all levels.
• Conduct study team training and site staff training.
• Present study status to internal and external executive leadership.
• Generate study documents including but not limited to: Project Management Plan, Communication Plan, Monitoring Plan, Risk Management Plan, Lab Manual, Study Procedures Manual, Site Templates.
• Maintain monitoring forecast and ensure adherence to the Monitoring Plan.
• Lead internal team meetings and serve as a resource for protocol and process questions.
• Serve as an escalation contact for site contracts, budget negotiations and site issues.
• Review data and site trends and determine Corrective and Preventative Action (CAPA) plans as needed.
• Assist the Data Management team with eCRF design, edit checks, data checks, and mid-study changes / software releases.
• Lead the clinical department's User Acceptance Testing process for the EDC and related applications.
• Define requirements and logic for customized study reports and ensure the completion of these reports from the Statistics and Programming department.
• Oversee the development and integrity of the Trial Master File (Wingspan).
• Manage the preparation and submission of regulatory packages per local regulations.
• Manage vendor contracts, relationships, and purchase orders.
• Lead the Clinical Operations Team in the evaluation and selection of a Clinical Trial Management System.
- Clinical Trial Manager at Health Decisions, Inc
- Senior In-House Clinical Research Associate at
- Agile IT Project Manager at
- Agile IT Business Analyst & Project Manager at Duke University Medical Center
1 year, 9 months at this Job
- B.S. in Information Sciences and Technology - Information Sciences and Technology
•Coordinate, implement and evaluate clinical research trials, studies and projects.
•Responsible for opening and closing 28-35 clinical trial studies including; Brest, Heme, Lung, Sarcoma, HIV and Prostate.
•Provide direction in the development of research protocols via the feasibility process.
•Performed essential support for clinical research trials throughout stages (I-IV) of study cycle.
•Tracked trial metrics such as; patient enrollment, physician study training, deliverables and data backlog.
•Identified and resolved site and sponsor related queries.
•Entered new patient study information into various databases for Sponsor visibility.
•Generated reports from various databases to support research program management.
•Developed departmental manuals, forms, documents and reference materials for study related purposes.
•Oversee financial accounts to ensure operations remain within approved budget limits.
- Clinical Trial Manager at McKesson US Oncology
- Regulatory Analyst at McKesson US Oncology
- Program Coordinator Practicum (Internship) at HIV Clinic
- Sr. Pharmaceutical Representative at Medimix Rx
1 year, 1 month at this Job
- Doctor of Public Health - (DrPH) Epidemiological Research
- MBA - Business Management
- Masters of Liberal Arts - (MLA) Journalism (Scholarship Awarded)
- Bachelor of Science - (B.S.) Biology