• Clinical lead for a late stage development project for treatment of male sexual dysfunction. Manage clinical and non-clinical studies requested by the FDA to support NDA filing. Coordinate consultants, vendors and Shionogi team to prepare for and attend a Type C meeting. Work with Global Project Leader to provide overall project management support.
• Oversee Phase 1 and Phase 2 trials in various therapeutic areas. Responsibilities include CRO identification and selection, oversight of CROs and other service providers during study conduct, monitoring, database lock, statistical analysis through final study report issuance. Manage trail/project budgets and timelines and communicate progress and issues to internal management teams.
• Follow and implement the study protocol development and clinical study reporting processes in conjunction with the Medical Director and key members of the Study Management Team (SMT; e.g. Biostatistician, Clinical Supplies Liaison, Data Manager, Regulatory Liaison, Pharmacovigilance, and Health Outcomes, if applicable).
• Work with the Clinical Supplies Liaison and Medical Director to forecast and maintain adequate clinical supplies.
• Interface with Medical Outsourcing and Purchasing regarding contract services. Ensure SMT participation in the development of study specifications/scope of work/project timeline for Request for Proposal (RFP) development and in bid defense, vendor selection and contract finalization meetings.
• Work with SMT to develop study budgets, including per patient costs, service provider costs, etc. Ensure timely payment to CROs and investigative sites and ensure study budgets are within forecast.
• Oversee planning of investigator meetings; participated in the presentation of operational information.
• Review and provide feedback to functional SMT members on Monitoring Plan/Data Management Plan/Statistical Analysis Plan.
• Communicate with investigative sites regarding study progress issues. Regularly communicate with internal and external study team members and provide updates to Shionogi's executive management.
• Assure proper study documentation is maintained and archived in the TMF.
• Facilitate and actively participate in process improvement initiatives, taskforces and committees within Clinical Operations and cross-functionally.
- Clinical Study Manager at Shionogi Inc
- Lead Clinical Research Associate at Cmed Research Inc
- Senior Clinical Research Associate at Alpharma Pharmaceuticals LLC
- Clinical Research Associate at Schering-Plough Corporation
2 years at this Job
- Completed all course work towards MS in biology with minor in business - Biology
- B.A. - Biology
- Clinical Study Manager at Novartis
- Coach at Aeon Fitness and Gymnastics
- Patient Care Technician at Holy Name Medical Center
- Research Associate at Skirball Center for Innovation (SCI), Cardiovascular Research Foundation
11 months at this Job
- B.A. - Biological Sciences and Psychology
• Coordinates/supports operational aspects for implementation of clinical trial activities from study start-up through database lock, ensuring Roche quality and safety standards, regulations, timelines and budget commitments are met.
• Performs/coordinates protocol and site level feasibility activities, including evaluation of patient population and final site selection (if applicable).
• Working with Hepatocellular Carcinoma, Acute Leukamia, Non Hodgkins Lymphoam trials (Phase1 and 3)
• Preparing study for audit readiness and performing ongoing etmf reconciliation
• Provides input into and/or develops study related materials such as Monitoring Plans, Recruitment Plans and Study Newsletters.
• Performing ongoing data clan activity and supporting Primary analysis
• Supports/coordinates the negotiation of site budgets within Fair Market Value (FMV) guidelines, budget plans and provides oversight for site payments per contract, as required.
• Maintains effective and ongoing communication with GSM; supports communication with local study teams and to sites as required.
• Works with global study team and GSM to manage or support the day-to-day activities of the study, including monitoring reports review, problem solving, issue escalation, timely closure of non-productive sites and tracking of safety procedures.
• Supports management of country-level Trial Master File (TMF) and reviews for quality (including translations, as applicable).
• Is responsible for the co-ordination and oversight of local affiliate study level audit/ inspection audit action plan activities.
• Provides feedback to local vendor manager and GSM on CRAs, and local supplier/vendor performance.
• Coordinates study or country communication plan.
- Clinical Study Manager/ Clinical Study Specialist at Roche
- Clinical Trial Lead at Revance Pharmaceutical Inc
- Sr. CRA at BioMarin Pharmaceutical Inc
- Sr. Clinical Research Assistant (CRA) at Enzo Life
11 months at this Job
- MS in Biology - Cell Biology, Molecular mechanisms, Anatomy and Neuroscience
- Post Graduate Diploma in Maternal and Child Care Health - Maternal and Child Care Health
- Post Graduate Diploma in Health Sciences Diabetology - Health Sciences
- Bachelor of Medicine and Bachelor of Surgery - Medicine and Bachelor of Surgery
Managed the overall conduct and integrity of several IDE and Postmarket clinical trials from protocol design through final submission to FDA, focused on endovascular stent grafts for treatment of thoracic and abdominal aortic aneurysms, dissections and other pathologies. resources and tools. Committee including charter creation, membership selection, meeting facilitation, and data presentation. completion rates, protocol deviations and adverse event documentation.
• Developed and implemented protocols, informed consent forms, regulatory documents, and other clinical trial-specific
• Participated in case report form (CRF) design and electronic data capture (EDC) system development and testing.
• Coordinated the activities of Data Safety Monitoring Board (DSMB), Clinical Events Committee (CEC), and Steering
• Conducted site selection, qualification, initiation, auditing, and closure activities.
• Created and delivered relevant training to investigators, site staff, and interdisciplinary colleagues.
• Managed investigational device distribution, use, return, invoicing and documentation.
• Tracked and reported trial progress to applicable internal stakeholders including screening, enrollment, data entry
• Evaluated clinical data for safety and effectiveness events, conducted cross-functional internal review meetings to assess events identified for potential additional safety reporting, and prepared reports for submission to FDA as necessary.
• Prepared annual clinical reports and other regulatory submissions to support Premarket Approval Application (PMA) and Postmarket requirements.
• Contributed to budget forecasting activities including development of clinical sites' and CRO budgets, as well as invoicing and payment approvals for participating sites and vendors.
• Directed activities of CRO monitors, including reviewing and approving visit reports, identification of missing or incomplete data, and verification of accurate documentation of protocol deviations at trial sites.
• Maintained an in-depth knowledge of standard operating procedures (SOP's), ICH-GCP guidelines, and applicable laws and regulations to ensure compliance and identify and mitigate areas of potential risk.
• Collaborated in internal continuous quality improvement initiatives and served as a superuser for implementation of a Siebel Clinical Trial Management System (CTMS).
Managed the overall conduct and integrity of several IDE and Postmarket clinical trials from protocol design through final
submission to FDA, focused on endovascular stent grafts for treatment of thoracic and abdominal aortic aneurysms, dissections and other pathologies.
resources and tools.
Committee including charter creation, membership selection, meeting facilitation, and data presentation.
completion rates, protocol deviations and adverse event documentation.
- Clinical Study Manager at W. L. GORE & ASSOCIATES, INC
- Clinical Research Team Lead at MAYO CLINIC
- Clinical Research Coordinator at MAYO CLINIC
- Research Assistant at CLINICAL RESEARCH ADVANTAGE
6 years, 11 months at this Job
- Master's - Health Administration
- Bachelor's - Physiology
• Designed imaging content for clinical studies (concept to submission, phase I-IV), created study budgets, timelines, assisted medical director in writing study protocols, and CRFs.
• Developed project scope, estimated budgets, assisted sourcing, compliance and legal departments, with CRO vendor, consultant physician selection and contracting processes.
• Built and maintained relationships with KOL physicians for possible consultancies and study participation. Helped design study site feasibility questionnaires, conducted pre study site visits, selected clinical sites, and performed FPFV training.
• Worked with global team based in EU to design, conduct, and deliver ICH and GCP compliant submission quality studies for FDA and EMA review.
• Led global teleconferences and produced and distributed meeting minutes to team.
• Tracked, managed and reported progress on multiple studies to stakeholders through weekly meetings, and presentations.
• Created and followed Vendor Oversight Plan for all studies involving CRO
• Managed clinical site relationships, resulting in faster CRF completion and corrections, oversaw CRO Blinded Image Evaluation (BIE) conduct, assisted with study closeouts and database freezes through vendor oversight plan.
• Supported trial close out activities by reviewing table listings, data analyses, writing clinical study reports and assisting the team with TMF reconciliation.
• Revised SOPs and finalized protocols and imaging documents through MyDoc version control document management system. Well versed in all Microsoft Office products, including Microsoft Project.
• Devised alternative imaging study design involving mobile CT trailers at phase 1 CRO facility that cut 6 months from study startup and enrollment from phase II study.
• Created novel phantom imaging study for pre-clinical needs, performed informal feasibility analysis using Excel.
• Conceived innovative strategy to retrospectively reread previous prospective diagnostic imaging studies and submit results to regulatory agency to obtain new label indication.
• Designed and delivered blinded read (concept to database lock) with seven readers in less than 10 months.
• Attended FDA meetings as sponsor imaging subject matter expert, fielding questions from panel directly.
• Assisted with on boarding and training of new departmental staff.
- Technology Leader/Clinical Study Manager at GE Healthcare Life Sciences
- Technology Research Associate at GE Healthcare
- CT Technologist at St. Luke's Hospital Network
- X-Ray Technologist/ Assistant at Fast Tracks Urgent Care
3 years, 11 months at this Job
- Bachelors of Science - Applied Science Technology
- Associates - Radiological Sciences
• Global study lead for Phase III trial (set-up, planning and execution)
• Resource, people management
• Study budget, timeline management
• Strategy development for the study to increase enrollment and overcome issues and challenges
• Meetings with KOLs and investigators
• Lead study to meet corporate goal from RFP stage within 3 months of joining the team
• Site level budget development and approvals
• Steering committee, DMC collaboration
• Issue resolution and team 'go to' person
• Planned and organized US IM, EU IM, APAC IM
• Strategic Alliance with Medical Affairs for site interactions
• Audit readiness set-up
• Development and mentoring of direct reports and junior team members across Clinical Operations
• Team building initiatives
• Establishment of safety operations processes and development of departmental level charters and processes
• Member of CRO and Central lab governance committees
- Sr. Clinical Study Manager at BeiGene, San Mateo
- A Member of the Roche Group at Genentech
- Sr. CRA/ Clinical Trial Lead at Abbvie Group of Companies
- Project Manager (Consultant) at Roche
1 year, 2 months at this Job
- Ph.D. in Medical Sciences - Medical Sciences
- M.S. (Biochemistry) - Biochemistry
- B.S. - Biological Sciences
completion of assigned studies conducted at Altasciences in accordance with protocol, SOP's, GCP, and GLP regulations. meetings/protocol review, serious adverse events and pregnancies, and overall status of trials. report.
completion of assigned studies conducted at Altasciences in accordance with protocol, SOP's, GCP, and GLP regulations.
meetings/protocol review, serious adverse events and pregnancies, and overall status of trials.
- CLINICAL STUDY MANAGER at Altasciences
- RESEARCH TECHNICIAN at Novum Pharmaceutical Research Services
- PROGRAM TECHNICIAN at United States Department Of Agriculture
- CLINICAL STUDY MANAGER at Cetero/PRACS Research
4 years, 4 months at this Job
- - Psychology
• Develop, implement and manage standards and processes for initiating study start-up activities.
• Management of all vendors involved in mobilizing for a clinical trial and following through on the governance of vendor deliverables.
• Execution of successful project initiatives to enhance current work practices and optimization of core tasks.
• Lead facilitator of vendor projects from bid defenses to project awarding.
• Serve as the operational lead in the day-to-day management of complex, rare disease studies or multi-study programs; supporting design, overseeing implementation, and delivery and reporting of these projects or programs
• Create feasibility strategies for decision making of what countries are most efficient for study enrollment and plot out strategic plans for new studies implemented.
• Develop and maintain enrollment projection for all ongoing studies.
• Ensured that study teams receive timely enrollment status reports, including monthly up to date projections of enrollment completion based on actual performance.
• Compile enrollment data at close of study for review by study teams.
• Maintain all systems used for study planning and generate monthly report matrix for review.
• Conduct UAT for upgrade of all study systems.
• Oversight of all monitoring of activities.
• Manage direct report including providing training of systems.
• Perform assessment of clinical protocols to assess the challenges of patient recruitment.
• Work collaboratively across multiple teams (CRO's, Business Development, Proposals, Project Management, Medical Officers, etc.)
• Assist in the development of patient recruitment programs across multiple therapeutic areas.
• Leading feasibility team, providing oversight and guidance to ensure consistent delivery of quality service.
• Work within all electronic data platform and provide training as needed.
- Clinical Study Planning Manager at CSL Behring LLC
- Clinical Trial Manager at Incyte Corporation
- at Janssen Pharmaceuticals, Inc
- Local Trial Manager at
3 years, 6 months at this Job
- Bachelor of Law - Law
- - Clinical Trial Set Up
- - research
- - Clinical
- - planning
- Clinical Study Associate at Daiichi Sankyo
- Solid Tumor Project Coordinator, Global Medical Affairs at Janssen Pharmaceutical Companies of J&J
- Clinical Operations Coordinator at Shionogi Inc
- Administrative Assistant at Matrix Development Group
4 months at this Job
- Bachelor's Degree - Psychology
• Provides day-to-day departmental/project support activities with primary responsibility for filing and maintaining the Clinical Trial Master Files (TMF), which includes review of received and in-house generated documents for accuracy and completeness. Files documents according to ACADIA procedures. Responsible for oversight if function is outsourced to a CRO.
• Assist Clinical Study Manager with oversight of third-party vendors if function is maintained by ACADIA.
• Processes clinical records and forms; updates and maintains clinical trackers; reports site/study status to the Clinical Study Team.
• Reviews required site essential study documents and files them as appropriate to remain in section readiness during the conduct of a study.
• Identifies potential compliance gaps as instructed.
• Organizes study information on the shared file drives and retrieves information from the CRO portals, if available.
• Prepares study and site regulatory binders and miscellaneous study materials.
• Coordinates the distribution of communications to all sites (e.g. questionnaires, newsletters, mass mailings, etc.).
• Submits required documentation for completion the Appendices of a Clinical Study Report (CSR) or inclusion into a regulatory filing.
• Sets up and attends meetings, takes meeting notes, and updates and distributes meeting minutes.
• Assists the study teams with financial tracking and reporting.
• Processes forms, requests for information by the team, and requests to obtain information from vendors and investigator sites.
• Organizes and helps plan meetings. May interact with meeting planners and travel agents.
• Performs other duties as assigned.
- Sr. Clinical Study Associate (Fidelis Consultant) at ACADIA Pharmaceuticals, Inc
- Nucleus Management, Consultant at Symphogen, Inc
- Clinical/Regulatory Specialist (Planet Pharma, Consultant) at TECLISON, Ltd
- Clinical Study Associate/In-House CRA (inVENTIV HEALTH CLINICAL Consultant) at DAIICHI SANKYO PHARMA DEVELOPMENT
5 months at this Job
- Master of Science - Psychology
- Bachelor of Science - Healthcare Management
- Associate of Science - Math and Science Program