The role of Global Senior Clinical Project Manager is to support the supply of Cog State Ltd so ware and services to companies and academic ins tu ons conduc ng clinical trials. To support the sales team in conver ng poten al
opportuni es with new or exis ng customers into new business. To be responsible for the training of new staff within the Opera ons func on.
● Follow up with poten al customers under advice from sales team
● Coordinate responses to request for informa on
● A endance at conferences including all clinical trials Kickoff and Inves gator Mee ngs
● Review of clinical trial protocols
● Advising customers on how best to implement CogState tes ng in clinical trials
● Designing/Wri ng suppor ng documenta on for clinical trials including o User manuals o Case Report Forms o Progress/Data reports
● Nego a ng scope of work and contract with customer and ensuring that terms are met
● Ensuring produc on and delivery of so ware
● End user tes ng of so ware
● Coordina on of hardware distribu on
● Training customers in the use of CogState tests
● Provision of technical support
● Archiving study documenta on and correspondence
● Training and mentoring of new members of staff within the Opera ons func on
● Focus on development and improvement of Opera ons processes
- Global Senior Clinical Project Manager at CogState Inc
- Senior Consultant at Keane Inc
- Assistant Director of Donor Relations at Lyme Academy College of Fine Arts
2 years at this Job
- ASN - Nursing and Psychology
- - Medical Lab Technology
• Communicates on a daily basis with sponsors and research sites to ensure that clinical research studies are performed in accordance within study protocol policies and procedures
• Conduct meetings with clinical staff and sponsors
• Create informed consent forms and corresponding source documents
• Familiarity with protocol preparedness
• Familiarity with submission to IRB
• Maintains regulatory and compliance of study specific trials
• Resolves data management queries within a timely manner
• Complete appropriate AE and SAE documentation according to study specific guidelines
- Clinical Project Manager at MB CLINICAL RESEARCH
- Clinical Research Coordinator/Clinical Laboratory Technician at MB CLINICAL RESEARCH
- Certified Audiology Assistant at EAR NOSE THROAT ASSOCIATES OF SOUTH FLORIDA
- Therapy Administrative Assistant at BROOKDALE SENIOR LIVING
6 months at this Job
- Bachelor of Arts in Biology - psychology
- High School Diploma
• Coordinated Phase I clinical trials focused on CNS disorders.
• Collaborate with internal and external team members for the planning and execution of clinical trials.
• Assist with development and management of project timelines and budgets; help ensure project deliverables are on time and within agreed upon budget and amended accordingly
• Ensure clinical trials meet time, quality and cost targets consistent with the overall Clinical Development Plan.
• Lead the development of, and provide input into, study-related documents, including clinical protocols, ICFs, CRFs, monitoring plans, study, lab and pharmacy manuals, data management plans, and final data package.
• Contribute to department process development, such as the development and writing of Standard Operating Procedures (SOPs).
• Collaborate with legal and finance (and others, as needed) on the development and management of study specific agreements (i.e. non-disclosure agreements, clinical trial agreements, clinical research organization agreements, payment terms, etc.)
• Oversee the conduct of studies to ensure trial participant safety is strictly monitored while remaining in compliance with local, ICH, GCP and company policies and procedures.
- Clinical Project Manager II at US WorldMeds LLC
- Director of Research at Chapters Health System Inc
- Site Manager at L-MARC Research Center
- Registered Nurse at Jewish Hospital
5 years, 11 months at this Job
- Bachelor of Science - Nursing
- Bachelor of Science
Managed Medical Device projects within the US and Globally. Oversaw the overall progress of the project as well as CRO and 'vendor management. Lead internal clinical team meetings and external vendor meetings. Provided weekly updates to stakeholders on the progress of the trial. - Developed and reviewed study related documents - Protocol, Informed Consent forms, Investigator Brochure, Pharmacy Manual and Clinical Study Report - Developed and maintained project plans - Scope, Timelines, Schedules, Cost and Resources - Defined, tracked and reported schedule attributes such as durations, milestones, critical path items and other key deliverables
- Senior Clinical Project Manager at Becton, Dickinson and Company
- Clinical Trial Manager at Ferring Pharmaceuticals
- Expert Global Trial Manager at Novartis Pharmaceutical
- Clinical Study Manager at Regeneron Pharmaceutical
7 months at this Job
- Bachelor of Arts
Lead interdisciplinary teams in the planning and execution of global cardiology clinical trials while adhering to budget, scope, and schedule. Facilitate the coordination of activities from functional groups comprising of trial design, clinical review and safety teams, site management, data management, statistics, and medical writing to insure proper trial conduct and submission of deliverables within contractual timelines ✓ Responsible for identification and selection of investigator sites for pivotal cardiology device trial ✓ Functioning as Site Management Lead by providing oversight to CRAs/field monitors, reviewing and approving monitoring reports and management of eTMF and CTMS tasks such as query resolutions ✓ Supporting FDA regulatory activities such as ICF revisions and submissions for IRB and CMS approval for early feasibility studies ✓ Facilitating the creation and approval of clinical trial documents such as SAP, PMP, SMP, and charters from CEC, DSMB, PRC, and Steering committees ✓ Collaborating with external DM teams on CRFs design, EDC functionality, and data reporting requirements ✓ Performing vendor qualification visits to ensure quality and regulatory compliance ✓ Evaluating sites based on study performance metrics and providing study status reports to senior management ✓ Providing financial management of study by reviewing contracts/budgets and initiating contract amendments/change orders
- Clinical Project Manager at BAIM INSTITUTE FOR CLINICAL RESEARCH
- Project Manager, Preclinical Drug Discovery at SILICON THERAPEUTICS INC
- Associate, Alliance Management & Business Development at FOUNDATION MEDICINE INC
- Clinical Research Coordinator at ATLANTIC CLINICAL RESEARCH COLLABORATIVE
7 months at this Job
- MASTER IN MOLECULAR SCIENCE - MOLECULAR SCIENCE
- BACHELOR IN BIOCHEMISTRY - BIOCHEMISTRY
• Responsible for the monitoring and management of all health care implementation projects, while executing operational tasks related to the full life-cycle of project management which includes the management of scope, issues and risks, oral presentations, facilitation of meetings, and detailed documentation.
• Serve as a clinical subject matter for Evolv and Avatar related projects.
• Cultivate and maintain relationships with clients.
- Clinical Project Manager at The Joxel Group, LLC
- Director of Homecare and Community Based Services, LLC at Milwaukee Center for Independence
- Director at Personal Assistance Services Program
- PAS Consumer Service Manager at IndependenceFirst
5 months at this Job
- Bachelors - Education and Development
• Primary point of contact for clinical operations responsible for leading communications with project teams (e.g. CMC, regulatory strategy etc.) to bring biopharmaceuticals to clinical phase and successfully complete clinical trials
• Proactively identify resource constraints, program risks, and conflicts that could impact timelines, and collaborate with project teams to develop appropriate mitigation and contingency plans
• Identify and oversee vendors and contract research organizations (CROs) in the execution of global clinical trials
• Attend conferences and meet with key opinion leaders (KOLs) to assess trial feasibility and select sites for orphan drug programs
- Clinical Project Manager at Lung Therapeutics
- Clinical Trials Project Manager at Novum Pharmaceutical Research Services
- Research Project Manager at VA Puget Sound Healthcare System
- Healthcare Career Counselor at St. Vincent Health
1 year, 3 months at this Job
- Bachelor of Arts
Responsible for the development, coordination and completion of projects supporting the clinical services department of Horizon Behavioral Health. Strengths include data management and reporting, process improvement initiatives and the ability to approach all tasks and projects with a methodical and exacting strategy for ensuring exceptional quality. Adept at problem identification, driver analysis and solution generation. Key Accomplishments:
• Annual development & facilitation of all clinical services trilogy documents for utilization management and intensive care management teams.
• Developed performance scorecards for eight clinical teams, measuring staff performance against established benchmarks.
• Facilitated the creation and enhancement of a quality audit program for all appeals and complaints activities.
• Successfully managed the reduction of out-of-network spend and allowed additional exposure to utilization and cost drivers.
• Project managed multiple initiatives for Horizon Behavioral Health, to include; Reduction of authorization errors; Development of automated monthly outlier reports; Development of master census for purposes of assessing utilization management metrics; designed various workflows to increase operational efficiency; supported the preparation efforts for multiple NCQA and/or URAC accreditations.
- Clinical Project Manager at Beacon Health Options
- Critical Care Transport Flight Paramedic & Medical Base Supervisor at Thomas Jefferson University Hospital
- Critical Care Transport Paramedic at Children's Medical Center
5 years, 1 month at this Job
- MA - Organizational Management/Healthcare Administration
• Collaborates with study sponsor, study sites and partners in study start up activities.
• Oversees the operational management of infectious vaccine trials in Africa and the USA by developing appropriate project plans and establishing targets for task completion.
• Coordinates the development and execution of study contracts and sub-agreements.
• Collaborates with the regulatory team in regulatory submissions and regulatory compliance at the site level.
• Develops study timelines and related milestones and monitors progress throughout the life of the study.
• Development of Standard Operating Procedure (SOPs) manuals and related departmental documents.
• Develops and modifies study budgets and is responsible for tracking site expenditures.
• Coordinates with the team lead in assigned studies to prepare progress reports and technical study documents.
• Coordinates the development and execution of new clinical research programs.
• Coordinates communication within projects and study sites and assists project coordinators with meeting management by developing meeting agendas and coordinating meeting minutes, appropriate distribution and follow up on action items with responsible parties.
• Conducts site visits and protocol trainings to ensures that clinical trials are conducted according to study guidelines, government policies and regulations.
• Supervises junior clinical project managers and project coordinators.
• Provides technical expertise to study team as needed to support assigned projects.
• Develops Grant and proposals to support new study activities.
• As a member of the Business Development Team, manages the Kenya Research Portfolio.
• Identifies new funding opportunities and develops proposals in collaboration with site teams and Proposal Development team.
- Clinical Project Manager II at Military HIV Research Program (MHRP)/ Henry Jackson Foundation
- Project Manager WESTAT at HIV
- Project Manager/Laboratory Specialist at WESTAT
- Protocol Specialist/ Clinical Research Associate at WESTAT
3 years, 4 months at this Job
- Master - Public Health
- Bachelor of Science - Medical and Research Technology
Current project: IDE medical device study
➢ Lead a team of 4 US monitors and 1 OUS monitor who review study conduct at 30 sites
➢ Create/maintain study documents adhering to quality system instructions and regulations ◦ Clinical Investigation Plan ◦ Investigator's Brochure ◦ Risk Management Plan ◦ Monitoring Plan ◦ Training Plan ◦ Site Assessment and Selection Plan ◦ Progress Report
➢ Utilize problem solving and critical thinking skills to ensure an accurate and successful study
➢ Possess and continue to gain knowledge of regulations; CFR 812, GCP, ISO 14155
➢ Promote and ensure effective communication with site personnel
➢ Collaborate with independent core laboratory to ensure study imaging requirements are followed
➢ Ensure site compliance is maintained
➢ Provide study protocol training to new study members
➢ Ensure study documents are in a state of audit-readiness always
➢ Perform data review with attention to detail and request remedy when needed via query
➢ Mentor incoming Clinical Project Managers
➢ SME - Identifying and Addressing Clinical Study Observations - perform training and provide support during inspection when appropriate
- Clinical Project Manager at Cook Research Incorporated
- Clinical Project Coordinator at Cook Research Incorporated
- Administrative Assistant to the Executive Director at Safe Passage, Inc
- Proximo Distillers Indiana, Human Resource Assistant at ADP/EZLM knowledge
2 years, 1 month at this Job
- B.S. - Organizational