To launch Oncology CAR-T therapy cell and gene clinical HUB program for DLBCL and ALL-Peds clinical trials. To merge both commercial and clinical HUB programs in order to promote efficiency across the organization.
• Managed communication with key stakeholders such as: PI's, CPO's, CRA's and CSM during CAR-T Trials for over 54 sites and 11 indications for Global Drug Development, Global Medical Affairs and Novartis Institute of Biomedical Research
• Developed and maintain a good working knowledge of relevant protocols.
• Implemented training materials to clinical trial and manufacturing teams, CPOs, CRAs and infusion sites on cell logistic process.
• Support cell logistic scheduling team and managed clinical supplies.
• Liaison between internal and external partners to manage slot allocation process and milestones.
• Participated in process improvements and development: WI, SOP and quick desk reference guides, training, process mapping for Clinical Trials and HUB patient support program.
• Assist with implementing a ground breaking clinical HUB program for CART-T therapy by leveraging collective hard work to deliver tools necessary to rise to any challenge.
• Assist with creating a system to effectively capture allocation/slot assignments and forecasting for clinical trials.
• Assist CRAs and GTM with SIV process for assigned site
• Provide support to Clinical Trial Manager (CTM) in site selection management
• Assist with providing work flow support to assure that departmental and cross functional systems and procedures are efficiently and correctly implemented.
- Clinical Trial Manager Oncology CTL019 at Novartis
- Mid-Atlantic Clinical Trial Manager and Case Manager at Intercept Pharmaceuticals/Conduent
- Patient Support Specialist Mid-Atlantic Region Oncology at
- Patient Support Specialist - Oncology at Cardinal Health
10 months at this Job
- - Good Clinical Practice
- B.S. in Psychology - Psychology
Cellular Immunotherapy Program for Induction of Immune Tolerance in Living Donor Kidney Transplant
● Responsible for implementing trial set-up, execution, oversight and reporting of clinical trials
● Developed clinical study protocols and ICFs. Facilitated in eCRF development and preparation of Clinical
- Sr. Clinical Trial Manager at Medeor Therapeutics Inc
1 year, 2 months at this Job
- MBA - Health Services Management
- MBBS - equivalent to MD
• Manage external vendors and contract research organizations
• Assist with clinical study report completion
• Manage monitoring activities at clinical sites
• Provide direction, guidance and management of CRAs
• Coordinate study supplies
• Maintenance of the trial master file.
• Review Informed Consent Forms
• Coordinate and Host Team meeting
- Temporary Consultant Clinical Trial Manager at Jazz Pharmaceuticals
- Temporary Consultant Project Manager at Catalyst Pharmaceuticals
- Clinical Trial Manager, Clinical Operations at Windtree Therapeutics, Inc
- Sr. Project Manager, Clinical Trials at Quest Diagnostics
at this Job
- Bachelor of Science degree - Clinical Laboratory Sciences
- Associate of Science in Clinical Laboratory Technology - Clinical Laboratory Technology
Developed and conducted global clinical trials on cell-free DNA (cfDNA) maintaining compliance with US FDA regulations and internationally recognized standards.
• Managed the activities of Quantgene Clinical Team and its partners including clinical sites, clinical research organizations (CROs), and consultants.
• Conducted research and data analysis for peer reviewed abstracts and publications. Collaborated with internal departments and external contractors to develop strategies for protocols, presentations and publications.
- Senior Clinical Trial Manager at Quantgene
- Clinical Research Coordinator at City of Hope National Medical Center - Duarte
- Clinical Research Coordinator, Screening Manager, and Assistant Project Manager at Innovative Clinical Research Institute
- Chief Medical Consultant at INC TOP 500 Company
4 months at this Job
- Doctor of Medicine (MD) - Medicine
Build, lead and manage a high performing Study Management Team. Plan, conduct and report clinical trials, within budget, on time, and with quality, from inception through close-out: Study Team Leadership: Build, manage, and maintain budgets, contracts and timelines for a given clinical trial. Prepare content for training materials and coordinate training on study procedures. In collaboration with medical director for study, create study plans and study specific working practices. Establish study team contacts, roles, responsibilities, and objectives. Develop, manage, and maintain relationships with external partners. Develop study execution plans and risk management plans. Facilitate effective communication between study sites and study team members to ensure ongoing successful execution. Provide ongoing mentoring and guidance to CTMAs/CPAs as well vendor partners. Establish and execute risk management plans when required. Study planning: Serve as project manager for the functional area in managing protocol execution. Oversee study planning and timelines to ensure alignment with overall clinical development plan Work with management to determine resourcing needs. With input from therapeutic area medical directors, lead the development of study documents including protocols, informed consent forms, and study manuals. Develop study budgets. Responsible for meeting timelines of investigational product manufacturing, labeling, release and management. Oversee setup and management of CTMS and the TMF. Selection and Evaluation of Investigative Sites: Participate in country selection. Review feasibility data. Identify prospective investigative sites and participate in final investigative site selection. Liaise with vendors to ensure quality site selection. Oversee negotiation of financial terms of individual site budgets. Manage/oversee site payments. Monitor GCP/ICH site level compliance. Identification and Selection of Vendors: Participate in preparation of RFP, assumptions and SOW. Recommend vendors. Contribute and review specs for affiliated vendors (IVRS, Labs). Vendor Management: Oversee all aspects of vendor management (performance, quality, timelines, deliverables, costs). Provide input, review, and approve vendor study specifications. Ensure appropriate escalation of issues as they arise. Review and approve/scrutinize specified costs on vendor invoices against contract. Participate in design and approval of various project and communication plans. Preparation of Study Documentation: Review essential regulatory documents. Establish and oversee risk management plan. Prepare, review and approve Monitoring Plan. Assure adherence to Monitoring Plan. Review eCRF specs (EDC) and review CRF completion guidelines. Design, review and approve study tools (for investigative site use). Facilitate development, review, and approve Data Management documents. Input Clinical Database, Safety and CSR Reports: In collaboration with Data Management, develop procedures and tool for data collection. Oversee collection of data to ensure compliance with protocol and clinical research project objectives, FDA/ICH/GCP regulations and guidelines. Review edits specifications. Execute EDC/IVRS User Acceptance Testing (UAT) scripts. Facilitate development and review of Clinical Data Review Plan. Review Summary Reports. Facilitate data review meetings. Participate in SAE reconciliation. Review and compile CSR and appendices. FDA/ICH/GCP regulations and guidelines: Review edits specifications (paper and EDC). Execute EDC/IVRS User Acceptance Testing (UAT) scripts. Facilitate development and review of Clinical Data Review Plan. Review Summary Reports. Facilitate data review meetings. Participate in SAE reconciliation. Review and compile CSR and appendices. Initiation and Site Start Up: Prepare and review material for investigator meeting and CRA Training. Conduct CRA training. Plan/organize/lead Investigator meeting. Provide oversight of country regulatory approvals. Oversee country/site IRB/EC approval. Review regulatory package (essential documents - blank forms and templates for 1572s, financial disclosure, etc.), Authorize investigational product shipment to investigational sites, including (in association with Regulatory Affairs) the initial shipment. Review and approve informed consent forms (e.g. site or country specific ICFs) Enrollment of Subjects: Ensure enrollment is tracked and recorded appropriately. Compile and report enrollment status to senior management. Update recruitment strategy. Address enrollment and retention issues. Maintenance of Sites, Subjects and Data: Track progress and milestones. Provide oversight of clinical monitoring to ensure quality data. Review and approve monitoring trip reports. Respond to questions requiring detailed understanding of study design. Review study data as defined by Study Team. Schedule and conduct CRA meetings /teleconferences. Follow up on outstanding eCRFs and data queries. Perform co-monitoring visits to ensure data integrity. Oversee resolution of study conduct issues. Address site issues found during audits. Maintain accuracy of trial information in all trial databases and tracking systems. Compile materials and data to support Data Safety Monitoring Board. Ensure ongoing reconciliation of TMF. Embrace and communicate change. Implement best practices and standards for trial management, share lessons learned. Study Close Out: Manage/oversee study close out activities. Reconcile payments to investigative sites and vendors. Reconcile study budget. Complete all archiving. Reconcile TMF. Provide operational support into the CSR.
- Clinical Trial Manager -Inflammation/Oncology at Gilead Sciences
- Clinical Scientist II/Contractor- Cardiovascular Nuclear Imaging at Forest Research Institute
- Clinical Scientist - Bone, Respiratory, Immunology, Dermatology Division at Merck & Co
- Senior CRA at SPRI Clinical Trials, LLC
5 years, 2 months at this Job
- BS - Biochemistry
- - Research Foundation Grant Recipient
• Contribute to the preparation of training materials (Investigator Meetings, Site Evaluation and Initiation Training).
• Manages CTA's and CRA's work performance.
• Manage process for planning and procuring ancillary clinical supplies.
• Facilitate and collate country recruitment plans.
• Create and manage study specific tools such as recruitment and retention materials and study newsletters.
• Act as liaison between Amgen and investigational sites/staff to build awareness on our company's global clinical development projects.
• Facilitate authoring of Investigational Product Information Manual (IPIM) and study specific Important Protocol Deviation (IPD) list.
• Compile IRB/EC submission documentation.
• Collaborate with both local and global organizations to promote the profile of Amgen clinical trials and knowledge with current and potential investigators.
• Assist with Global Development Operations (GDO) Operational Review preparation.
• Prepare Clinical Study Team (CST) meeting agendas and minutes.
• Independently perform actions associated with the evaluation and proficiencies of investigational sites and ensure they are complying with ICH/GCP and local regulatory requirements.
• Manage global versioning and distribution of informed consent forms (ICFs).
• Facilitate cross functional meetings.
• Submit documents to trial master file (TMF) in EPIC.
- Global Clinical Trial Manager at Docs Global FSP
- Global Clinical Trial Manager at Accelovance
- Project Manager at
- Associate Project Manager at
2 years, 7 months at this Job
- Bachelor of Science - Criminal Justice
Managing Phase 1, 2 and 3 Global Oncology Clinical Trials for a major Pharmaceutical Company
- Clinical Trial Manager at PRA Health Sciences
- Manager Clinical Trials at Orlando Health
- Senior Project Manager at inVentiv Health
- Senior Director at Clinical Trial Management
2 years at this Job
- Bachelor in Science - Biology
o Lead coordinating manager for multiple Translational Breast Cancer Research Consortium (TBCRC) studies increasing specimen submission and site point accrual for 2018-2019 o Managed all Tissue collection studies developing new standard of procedures to improve communication between various hospital entities involved in specimen processing and improved cross collaborations with Surgical Oncology o Successful management of CTSU, CPDMU, NCI, central IRB for all studies and long term patient follow up.
- Clinical Trial Manager at Montefiore Einstein Center for Cancer Care
- Research Associate at Weill Cornell Hospital for Special Surgery
- Graduate Student Research Associate at New York Presbyterian Morgan Stanley Children's Hospital
- Program Director - New York at New York City Health & Hospitals Gotham Health
6 months at this Job
- Certificate - Epidemiology of Chronic Disease
- Bachelor of Science - Religious Studies
Remotely located in California, USA Device/Pharma/Biologics/Spine/Oncology/Pain * Consistently exceeding milestones by leading trial teams ahead of schedule and under budget for multiple clinical trials * Recipient of Corporate Performance Award and 'Exceeds Expectations' performance reviews * Responsible for all trial management activities for multiple clinical trials for oncology, biologics, pain management, and restorative therapies * Lead and author protocol design, author clinical/regulatory documents, abstracts, etc. * Collaborate with Key Opinion Leaders (KOLs), Health Care Professionals (HCPs), and Primary Investigators (PIs) to lead publication strategy and data analysis/clinical evidence outcomes * Recipient and presenting author of top 10 scientific abstracts at global scientific symposium * Primary author for multiple study plans, protocols, informed consents, eCRFs, and all clinicals/regulatory documents
- Clinical Trial Manager at Medtronic - Restorative Therapies Group (RTG)
- Clinical Scientist at Pfizer
- Principal Clinical Scientist / Medical Writer at Boston Scientific
- Senior Clinical Scientist / Medical Writer at Abbott Vascular
4 years, 2 months at this Job
- - Registered Nursing
• Manages all operational aspects from start up to close out for assigned clinical studies supporting multiple protocols across Phases I, II, and III in PNH and aHUS
• Operational lead for oversight and management of PNH Clone vendor; including contract/budget negotiations, budget management and scope changes, execution of deliverables according to scope of work and planned timelines; issue escalation and implementation of corrective action plans where needed
• Key contributor to development, implementation and maintenance of study related documents (e.g. monitoring plans, ICF, protocol amendments, oversight plans, TMF plan)
• Review and approval of GCP essential documents required for release of investigational product to investigational sites
• Assess/review of the clinical monitoring activities and site performance through review of trip reports to ensure data quality/integrity as well as subject safety
• Oversees set up and maintenance of study systems including but not limited Trial Master File (TMF), IXRS, and Study Training portal
• Lead on department initiative for registration of studies to ClinicalTrials.gov. Received a 'Living the Values' award for successful management of cross collaboration with departments, driving process to completion, attention to detail while learning and educating peers on regulations and requirements
• Leads subject matter trainings to CTM group and mentors junior CTMs in their role
• Continual recognition as part of a high functioning team that executes goals and exceeds milestones meeting R&D and company objectives for 1210 program, and individually as a contributor for operational tasks which help to reach study-specific deliverables.
• Part of successful team recognized for achievement of FDA Approval of Ultomiris (TM) (ravulizumab-cwvz).
- Clinical Trial Manager (Rare Diseases) at Alexion Pharmaceuticals
- Global Study Manager/CRA at Durata Therapeutics
- Clinical Research Coordinator (CNS) at Associated Neurologists of Southern Connecticut
- Clinical Project Manager at CogState, Inc
3 years, 9 months at this Job
- Masters of Business Administration - Healthcare Management
- Bachelor of Science in Health Management - Health Management