Primary operational point of contact with study sponsors and third parties during the entire phase of a diabetes, metabolism or endocrinology, and Energy expenditure clinical trials
• Manage all aspects of clinical trials from launch to completion
• Manage and Support staff in day-to-day clinical and administrative activities and procedures
• Assist in development and implementation of research protocol budgets
• Work with Recruitment staff to ensure all study specific volunteer recruitment activities, including creation and placement of study specific advertisements, meet GCP requirements.
• Supervise and assist clinical staff in completion of documentation of discrepancies by Clinical Project Manager Assistant and other Clinical Operations staff
• Responsible for managing study tracking tools including study information files (study sheets, CRF completion tools, PM tool, etc )
• Administer IRB approved informed consent forms to subjects following Good Clinical Practice Guidelines (GCP)
- Clinical Project Manager at Profil Institute for Clinical Research, Inc.
- Clinical Trials Supervisor at Scripps Health
- Regulatory Affairs Officer/Project Manager at Affiliated Research Institute
- Clinical Research Associate II at City of Hope Medical Center, Duarte
2 years at this Job
clinical Research Monitor (Core Clinical Solutions Group/Remote)
• Responsible for planning, scheduling and implementing the Clinical Operations aspects of projects.
• Oversight of all study sites, in cardiovascular and neuromodular protocols in various business units.
• Collaboration across multi-functional business groups to develop and maintain cross functional project management plans.
• Conduction of interviews and hiring of personnel to fill clinical trial monitoring needs per monitoring plan and budget.
• Overseeing the management of regulatory inspection preparedness and TMF documentations to ensure that all issues are resolved prior to inspection.
• Frequently meeting with team leaders, policy owners and leadership to discuss the implementation of established policies and improvement on procedures.
• Creating a culture of process improvement that focuses on streamlining clinical trial processes adding values to business units and meeting client needs.
• Serving as the primary point of contact for Clinical Operations aspects of designated projects and responsible for developing successful working relationships with other business units.
• Responsible for planning, scheduling and implementing the Clinical Operations aspects of projects.
• Responsible for risk mitigation strategies, associated action plan and issue resolution with designated projects.
• Participates in clinical projects costing and budget planning, review, and defense.
• Responsible for managing the Clinical Operations project team, including ensuring all necessary project training is provided to assigned staff.
• Meets frequently with Lead monitors and provide direction and support to the Clinical Operations study team.
• Periodically track and analyze Clinical Operations project deliverables to ensure adherence to monitoring plans, project protocols and company policies while focusing on meeting project deadlines.
• Conducts monitoring visit with monitors infrequently to address major needs whenever necessary. ► MEDTRONIC INC., MOUNDS-VIEW, MINNESOTA, USA. Nov. 2017 - Present Clinical Project Manager/Principal clinical Research Monitor
- Clinical Project Manager/Principal at MEDTRONIC INC., MOUNDS-VIEW, MINNESOTA
- Clinical Trial Manager/ Lead Clinical Research Associate (Contract role, Nationwide) at KCI
- Senior Clinical Research Associate (Nationwide) at NEURONEX INC
- Clinical Research Associate at NEURONEX INC
1 year, 2 months at this Job
- License - Reg. #
- Doctor of Philosophy - MD-PhD
- Bachelor of Science - Biochemistry
- Masters of Business Administration - Public Health
Clinical Project Manager on the following Clinical Trials:
- Phase II High Risk Myeloproliferative Neoplasms
- Phase I Advanced Solid Tumors Studies
- Phase I Blastic Plasmacytoid Dendritic Cell Neoplasm
• Involved with preparation and execution of successful FDA audit at both the sponsor and site level in support of BLA submission
• Provided management and oversight of CRO and vendors
• Collaborated with and acted as resource to cross-functional teams during all phases of a clinical studies, including site start-up activities, protocol deviation assessment, safety reconciliation, biological sample reconciliation, query resolution, data lock activities, analysis and export of safety data to FDA
• Managed all life cycle stages of clinical trials and collaborated with cross-functional teams to ensure successful completion of deliverables within timelines and budgets
• Lead study management meetings and teleconferences with internal and external stakeholders
• Created study-specific training materials and documents including but not limited to: case report forms, completion guidelines, study manuals, project tools, project plans, tracking tools and informed consent templates
• Provided support during contract and budget negotiations with investigator sites
• Responsible for invoice review and approval as well as tracking of payments
• Extensive monitoring report review, issue escalation and resolution as well as risk mitigation activities
• Involved in team resourcing and management of CRAs
• Maintenance of electronic trial master file
• Provided ongoing guidance, training and mentoring to junior team members
- Clinical Project Manager at Stemline Therapeutics
- Regional Clinical Trial Manager at DOCS Global Inc. / ICON Plc
- Senior Clinical Research Associate at DOCS Global Inc. / ICON Plc
- CRO at Novotech
1 year, 5 months at this Job
- Bachelor of Health Science - Health Science
• Manages projects of limited scope (functional or regional). Responsible for project team leadership.
• Responsible for building and maintaining positive client relationships
• Ability to negotiate with clients to assure Novella’s operational processes are maintained, projects are done within scope
• Reviewing and identifying project study trends and proactively responding to client and respective team members
• Developing appropriate early warning systems of potential obstacles to the successful completion of the projects; analyzes information and develops innovative solutions to challenges
• Identifying, define, document training requirements in LMS systems and assure project level compliance with study specific training requirements
• Responsible for change management on all assigned projects
• Responsible for assuring projects assigned are run according to SOPs and WP as defined in the scope of work
• Responsible for identifying processes which need updating and documenting that to the direct line manager or divisional lead
• Responsible for maintaining client relationships for all assigned work, keeping all project reporting current, and assuring executive management is aware
• In conjunction with management, assists with developing, documenting, and updating internal processes and processes required for consistency across programs such as SOPs, working practices, and related quality assurance forms.
• Oversee delegation of support staff activities, as necessary
• Assists in the development and delivery of capability and proposal defense presentations to prospective clients
• Supports Contracts and Proposals with final project contract execution and CIS documentation by the project team.
• Participates in the performance appraisal program by providing timely and accurate feedback regarding the performance of respective team members at least annually
• Maintains current knowledge of FDA regulations, and GCP and ICH Guidelines for clinical research.
• Responsible to maintain personal currency documentation for Novella SOPs, CAPA completion and timesheet maintenance including assurance or back-up PM staff at each and every instance of out of office
• May support Director, Project Management, and Project Management team as required by providing appropriate staff management for awarded programs.
• Supports Project or Program Managers with directional insight for Change Orders and Out of Scope work; Assists in communication of budget allocations and approval of invoices.
• Responsible for supporting Project Managers/Program Managers thorough management of project timelines. Assist/Manage in the development of project timelines and milestone tracking.
• Through matrix reporting, responsible for supporting project teams both administratively and technically as appropriate.
• Participates and assists in the planning and creation of client and investigator meetings and related materials.
- Associate Clinical Project Manager at IQVIA
- Sr. Project Management Analyst in Clinical Research at QuintilesIMS
- Project Management Analyst in Clinical Research at
- Clinical Monitoring Associate at PAREXEL International
1 month at this Job
- Bachelor of Science - Biology and Health Science
• Acted as primary operational interface to assist in the planning and execution of clinical trials while adhering to budget, scope and timelines.
• Responsible and accountable for the coordinated management of all aspects of multiple clinical trials including: CRO and vendor selection, oversight to ensure patient safety, adherence to the contract, protocol, safety regulations, and data integrity.
• Sourced, screened, pre-qualified, interviewed, and performed critical evaluation of clinical trial investigator's, as well as his or her staff candidates to determine their core competencies and qualifications for potential participation in clinical trials;
• Utilized efficient and effective clinical recruitment strategies including passive techniques such as professional networks, data mining, social networking, LinkedIn, and Boolean searches;
• Lead planning and communication with cross-functional study teams to ensure proper execution and conduct of the trials.
• Served as primary point of contact for internal/external customers and vendors.
• Built credibility, established rapport, and maintained communication with stakeholders at multiple levels, including those external to each organization.
• Provided day-to-day leadership in conjunction with the Director of Clinical Operations, in the development and implementation of integrated strategic and operational plans for each project.
• Developed and coordinated clinical study activities and managed their execution to ensure completion according to project timeline, budget and Standard Operating Procedures (SOPs).
• Defined and initiated projects, and assigned Monitoring Managers to manage cost, schedule, and performance of component projects, while working to ensure the ultimate success and acceptance of the project.
• Coordinated the creation and maintenance of the integrated Project Management Plan, Resource Plan, budget and timeline for each individual project.
• Tracked the progress of projects, identified issues needing attention, and lead contingency planning.
• Lead vendor selection and performed ongoing vendor management, including independent negotiation of vendors' scopes of work and budgets, performance management and issue resolution (i.e., CRO, Call Center, Central Laboratory, and Physician Networks).
• Interviewed and screened new hire CRAs; collaboratively defined staff development goals, and performance metrics.
• Ensured internal and external Clinical Professionals assigned to projects were efficiently trained on all relevant protocols and SOPs.
• Ensured global study compliance with GCP/ICH and regulatory requirements and worked cooperatively with Quality Assurance with respect to site and/or internal audits.
• Maintained continuous alignment of program scope with strategic business objectives, and made recommendations to modify the program to enhance effectiveness toward the business result or strategic intent.
• Mentored and lead personnel within a remote team environment.
• Prepared, reviewed, and edited clinical documents and regulatory submissions: Clinical Summaries, protocols, informed consent forms and SOPs.
- Clinical Project Manager/Associate Project Manager - Consultant at Edwards Clinical Consulting, Inc
- Clinical Trial Support - Consultant at Edwards Clinical Consulting, Inc
- Sr. Clinical Research Associate - Consultant at Edwards Clinical Consulting, Inc
- Regional Sr. Clinical Research Associate at Genentech, Inc
5 years, 3 months at this Job
- Bachelor of Arts - Public Health
North Chicago, Illinois 02/2012 - present
Sr. Clinical Project Manager (Consultant), Global Clinical Development Operations
• Provide clinical research project/program management consulting services in Global Clinical Development to support AbbVie's (formerly Abbott) Ex-US Affiliates in planning, execution and management of global clinical development programs
• Collaborate closely with global cross-functional project team/affiliates, functional areas, and Global Medical Director to strategically and expeditiously plan, design and execute clinical trials
• Plan, develop and track resources, timelines, budget and deliverables for clinical programs to support efficient execution of business-critical activities. Oversight of vendors activities and deliverables
• Contribute to problem solving, risk mitigation and contingency planning at global level to ensure successful execution of clinical projects in support of program and portfolio objectives
• Collaborate with functional stakeholders (core Global Project Team) to drive coordination of all activities related to clinical project deliverables.
- Sr. Clinical Project Manager (Consultant), Global Clinical Development Operations at Abbott Laboratories
- Associate Director at Global Clinical Research
- Director, Clinical Development at NEOPHARM, Inc
- Director, Clinical Research at DECODE Genetics, Inc
6 years, 11 months at this Job
- M.P.H. - Public Health
- M.B.B.S. - Medicine & Bachelor of Surgery
• Develop a NCI CTRP Overview PowerPoint presentation and training materials for stakeholders, cancer centers, and incoming team members by developing agendas and logistics including scheduling using WebEx.
• Manage the Clinical Trials Reporting Office (CTRO) request tracking system , Enterprise Wizard, identify trends in customer inquiries, issues and suggestions for system enhancement. Communicate with stakeholders using comprehensive and continuous tracking of requests to ensure timely responses to all submitters.
• Triage incoming requests to the Clinical Trials Reporting Office (CTRO), prioritize requests and assign to the appropriate team queue for processing. Perform outreach on behalf of stakeholders to request accrual discrepancies, participating site information, and update trial information.
• Assist stakeholders by reviewing accrual submission errors, which includes a comprehensive analysis of the accrual batch report to identify any data discrepancy and assisting the submitter with resolving the discrepancy
• Develop User Support training program for the Clinical Trials Reporting Office (CTRO) and identify opportunities for cross training, and assist with supervising staff
• Collaborate with team managers and the Director of the Clinical Trials Reporting Office (CTRO) to implement a standard for communication between all stakeholders by creating and maintaining a project communication plan.
• Add persons and/or organizations to Clinical Trials Reporting Program (CTRP) as requested by designated cancer centers, update persons and organizations as necessary including processing change requests received from CTEP.
- Associate Clinical Project Manager at Leidos Biomedical Research, Inc
- Administrative Assistant at Anesthesia Company LLC
- Protocol Data Analyst II/Person & Organization Curator at Essential Software Inc
- Document Management Technician at Anne Arundel Medical Center
1 month at this Job
- Bachelor's Degree in Healthcare Management - Healthcare Management
• Serve as the clinical operations lead for global protocol(s) to ensure proper executed and timely completion per the development plan
• Provide clinical operations input to the development and authoring of protocols and amendments, as assigned.
• Provide oversight of the partner CRO in their conduct of the day-to-day operations and ensuring they are effectively managing of all aspects of the study according to the specificities of the scope of work
• Control project team activities to ensure ICH-GCP guidelines and SOPs are strictly observed, including study preparations, site initiations, periodic monitoring, status and safety reporting
• Regularly meet with CRO partner to ensure study conduct and completion are progressing according to needs and established study timelines
• Coordinate all ancillary aspects of the study, including vendor management, data management, pharmacovigilance, statistician, and medical writer;
• Serve as a mentor and provide guidance and training to junior Project Managers and Lead CRAs and positively influence team members to achieve objectives; Present and participate in on-going clinical research training.
• Coordinate IEC/IRB submissions in North America, Europe, and APAC regions. Prepared and reviewed responses to questions from regulatory authorities, and IECs/IRBs
• Provide clinical input into the development of study-specific plans, CRF's, Statistical Analysis Plans, and IVRS requirements/planning documents.
• Experience in study budget forecasting and management in addition to negotiating site and vendor budgets
• Manage, audit and ensure quality of content of Trial Master File including archiving
• Conducts Monitoring Oversight & Co Monitoring Visits. May serve in the Clinical Oversight Lead role as required
• Reviews and approves Oversight Reports; familiar with trends from oversight and ESP trip reports
• Approves selection of appropriate clinical staff by the ESP
• Facilitate CAPA activities related to site monitoring, Trial Master File, and other clinical activities. Conducts follow-up activities to promote adherence to CAPA plans and continuous improvement
• Provide study-specific direction and mentoring to Clinical Trial Associates and support staff.
- Sr. Clinical Project Manager at Premier Medical Research Management
- Lead Clinical Research Consultant at Premier Medical Research Management
- Sr. Associate, Clinical Site Management/Protocol Team Lead at Amgen
- Contract Employee at RPS
6 years, 1 month at this Job
- Master of Health Administration
- Bachelor of Science - Biology/Pre
• Develop and manage multidisciplinary project team members related to project management activities requiring interaction with internal groups including clinical science, data management, pharmacovigilance, shipping/logistics, regulatory affairs, quality assurance and business development during clinical study lifecycle.
• Define and monitor project scope, timelines and deliverables from project initiation to close out. Ensure project plan aligns with contract requirements, and address any reconciliation required.
• Schedule, plan for, and document regularly scheduled project team meetings. Assess project issues, propose resolutions to the project team, Clinical Director, company executives and/or the Sponsor, and then track implementation of resolution through to completion.
• Ensure the overall quality of project services and deliverables by documenting project/clinical trial progress to ensure completeness of documentation and data collection, management of supplies and resources in adherence with the project timelines, budgets and quality standards including central laboratory and contract/academic research organizations.
• Participate in the design, writing and review of all project-related documents including: budgets and proposals, change orders, and study content documents including protocols, case reports forms, statistical analysis plans, study reports and monitoring documents. Development of informed consent forms, study documents and study management tools.
• Implement risk mitigation actions at the project level (raise to program level, as necessary)
• Implement corrective actions as needed to maintain project performance
• Ensure quality reviews occur at key points with the participation of the appropriate personnel
• Ensure project deliverables comply with corporate standards and quality guidelines
- Clinical Project Manager at ICON GPHS
- Expert Global Trial Manager at Novartis Pharmaceuticals Corporation
- Clinical Project Manager at Bio-Analytical Research Corporation
- Clinical Project Manager at ICON Central Laboratories
8 months at this Job
- Bachelor of Science
- Associate of Science
• Manage neuroscience imaging projects for phase I-III global clinical trials from study start-up to close-out
• Coordinate across functional groups including operations, data management, QA, and science teams to establish goals and strategize for project success
• Lead regular conference meetings with study sponsor, CRO, vendors and internal teams; prepare agendas and minutes
• Develop project plans and study documents including Manuals, Quick Reference Guides, Study Specific Procedures, and Imaging Charters
• Develop and deliver team project training and ensure teams are resourced appropriately
• Establish reporting schedules and share study progress and metrics
• Perform financial tasks such as monthly billing, forecasting, and pass through cost management
• Prepare and deliver presentations at investigator meetings
• Follow SOPs and participate in sponsor and internal audits
- Clinical Project Manager at Bioclinica
- Research Assistant at Molecular Medicine Research Institute
2 years, 1 month at this Job
- B.A. in Molecular & Cell Biology - Immunology & Pathogenesis