Clinical Project Manager Resume
Summary : A proven self-starter with strong technical and interpersonal skills, with the ability to provide strategic and creative thinking to deliver growth and substantial results.
Skills : Phase 1- 4 Clinical Trial Management, Microsoft Office, Microsoft Project.
- Responsible for Clinical Supplies Management: collaborate with GCS, Stats - random code generation request; collaborate with appropriate areas to provide input regarding IMPQC issues as required.
- Oversaw communication with sites, countries, monitoring groups and vendors regarding clinical supply expiration and recertification information, overall shipping timelines and identify clinical supply needs at the protocol level with details regarding scope timing, comparator, packaging and ancillary supply needs.
- Collaborated with CS/CDM to set-up database, design data collection tools and programmed queries.
- Oversew Clinical review of data/study-specific listings and queries.
- Participated in SAE reconciliation (Clinical vs.
- Interfaced with monitors/sites and vendors to facilitate query resolution.
- Participated in Protocol Acceptability Criteria Meeting Validation.
Sr. Clinical Project Manager Resume
Summary : Clinical Project Manager with 15+ years of experience in all aspects of managing Phase I-IV clinical trials encompassing pharmaceutical and medical devices. - Management of clinical trial site, which included, site selection and evaluation, trial set-up, study drug management (tracking, dispensing and disposal), investigator selection monitoring, regulatory submissions, trial reports and training of staff on clinical protocols.
Skills : Clinical Project Manager, Clinical Research.
- Conducted throughout phases (I-IV) of pharmaceutical interaction within blinded and unblinded drug trials.
- Experienced in adhering to GCPs, protocols and SOPs along with IRB, ICH and FDA regulations Schedule and prescreen patients for studies according to study protocol requirements.
- Performed subject visits as allowed by study protocol and assist Investigators during subject visits.
- Monitored patient visits and progress throughout study.
- Reported all deviations, AE's and SAE's according to study protocol and ICH/GCP guidelines.
- Developed and finalized complete project plans with formalized project milestones and deliverable schedule Presented and led presentations at .
- Responsible for the overall project management of Investigator Initiated trials that were conducted across multiple therapeutic areas, including.
Bachelor Of Science
Jr. Clinical Project Manager Resume
Objective : Healthcare Information Technology executive with a clinical (Registered Nurse), technical (former Epic employee) and management (Director level positions) background. Extensive experience in EMR implementation and project management. Additional experience in Vendor Operations, Sales Demonstrations, Marketing, Product Management and working with both certification and standards organizations.
Skills : Epic Systems, Project Management.
- Acted as the Application Manager for Inpatient Documentation during their national Enterprise implementation.
- Acted as the Application Manager for Inpatient Clinical Documentation during their Enterprise implementation.
- Acted as the Application Manager for their Home Health implementation.
- Acted as the Application Coordinator and then Application Manager for Inpatient Clinical Documentation during their Inpatient and Ambulatory implementation.
- Supervised, mentored and coached Clinical Affairs Specialist Developed policies and procedures for the Clinical Affairs Department Responsible for .
- Executed Company's initial IDE/PMA submission.
- Aided in the clinical sale within the business unit, as well as participate in and manage the client in-servicing and staff training of the product .
Bachelor Of Science
Clinical Project Manager III Resume
Summary : Accomplished Global Clinical Project Manager. Proven successful management and leadership of multi-disciplinary teams in the planning, preparation and execution of clinical protocols. Consistently deliver high energy, dedication, enthusiasm, flexibility and adaptability in day to day project management responsibilities.
Skills : Clinical Trials Operations, Clinical Trials Operations, Vendor Contracts, Vendor Contracts.
- Responded to metrics findings to facilitate improvements at the site level and keep the sponsor informed of actions taken.
- Conducted formal presentations of services including training of investigative sites on equipment and processes at investigator meetings, on site training, or telephone training as needed.
- Provided and documented protocol specific training to assigned data specialists prior to study start and perform ongoing periodic audits of each technician's performance and error rate to ensure high quality.
- Trained it and technical support teams on requirements for providing support create protocol specific site training manuals, internal processing instructions, and formal training presentations.
- Develop user manuals for research software/equipment utilized at clinical sites.
- Coordinate logistics support and training to ensure proper equipment preparation and timely deliveries.
- Organized and managed all study start-up and closing procedures including development of required forms, spreadsheets and periodic reports as specified.
- Provided protocol specific software and data processing requirements to director of pulmonary services and engineering teams.
Clinical Project Manager II Resume
Summary : Promise Health Care Clinical Documentation 2 years Pacific Health Corp Quality/Performance analyst Director of Clinical Documentation 4 years Prime Health Care Case Manager/Clinical Documentation Specialist 3 years Omegas Consulting RN Chart Auditor/Case manager/Trainer 4.9 years Western Medical, Irvine Case Manager 2.
Skills : Computer, Computer, Medical Terminology, MS Office, Medical Devices.
- Conducted site qualification visits, site initiation visits and attended procedures as clinical research professional for randomized, controlled, .
- Tracked clinical timelines and documentation for open, prospective OUS study to ensure compliance with study protocol, Good Clinical Practices, and .
- Co-monitored multiple study sites with CRAs; provided guidance and direction, manage staff Served as site manager for multiple studies Acted as the .
- Acted as a research liaison between Cerner and clients, coordinating research studies for medical devices in the areas of new product development, market assessment, and customer satisfaction.
- Installed Medical Device interface software for acute care hospitals for Labs.
- Coordinated with clients for testing of interface functionality.
- Resolved system software and application software functionality failures.
Clinical Trial Research
Clinical Project Manager I Resume
Objective : Over 15 years experience as Global Project Lead, Senior Global Trial Manager, Senior Clinical Study Manager, Clinical Project Leader, Senior Clinical Research Associate/Clinical Research Associate and Charge/Staff Nurse working for industry leading pharmaceutical companies and health care organizations. Proven abilities to manage complex Phase I, II and III clinical trials with responsibilities encompassing domestic/international project team coordination, GCP/SOP compliance and action plan development.
Skills : Clinical Research, Clinical, Protocol Development, Clinical Monitoring, GCP, Clinical Trials.
- Responsible for the overall adequacy of conduct, data quality, compliance and adherence to timelines for their assigned trials in the US.
- Interfaced with corporate Clinical Trial Managers, Regional CRA Team, Medical Monitors and Trial Monitors (MD) for operational input for feasibility trial, design/methodology, standard US medical practice and data capture.
- Assumed overall responsibility for negotiation of development and management of the clinical trial.
- Negotiated financial aspects of the clinical trials with individual sites.
- Collaborated with the medical monitor in the safety evaluation of study subjects in the trial.
- Ensured all aspects of study site management are conducted appropriately, i.e.
- Organized the team work, equally distribute the tasks and insure the quality of work done.
Assistant Clinical Project Manager Resume
Objective : Motivated self-starter with exceptional project management, research and analysis skills. Able to work cross-functionally and within short time lines to meet team, department, and company goals. Deep domain expertise and high attention to detail developed over the past 10 years of employment within the Clinical Research arena.
Skills : Proficent with Microsoft Office Suite and Outlook. Proficient with the Minimum Data Set/Resident Assessment Instrument.
- Responsible for coordinating, organizing, executing and managing all requirements for clinical trials requiring centralized pulmonary services.
- Responsible for leading and coordinating the development process for clinical pilots, projects and programs. Projects will require managing resources provided by cross-functional McKesson teams and outside resources. Responsibilities must cover the process from design through implementation, evaluation and release.
- Provided a single point of contact for projects. Takes projects from original concept through final implementation.
- Provided protocol specific software and data processing requirements to Director of Pulmonary Services and engineering teams.
- Interfaced with quality Management, Data Management, Logistics and IT departments to ensure high quality service.
- Organized and Manage all study start-up and closing procedures including development of required forms, spreadsheets and periodic reports as specified.
- Coordinated Logistics support and training to ensure proper equipment preparation and timely deliveries.
Associate Clinical Project Manager Resume
Headline : Over 5 years of progressive experience of product development in Clinical/Pharmaceutical areas. Collecting and conducting data analysis and interpretation, and coordinate and review regulatory documents on timely basis. Facilitation reports, implementation, project status reports, oral presentations.
Skills : Management (10+ years), Leadership Development.
- Included scheduling, budgeting based on scope of the project.
- Ensured managing trials in compliance with all federal regulations.
- Worked with the sponsor, CRA's and project team.
- Coordinated activities, create agendas, schedule meetings and follow up action items.
- Presented cross-functional activities in support of studies during meetings.
- Discussed budget status and communicate issues and build time reserve for contingencies.
- Prepared meeting minutes and conduct sprint sessions for risk management.
Assistant Clinical Project Manager I Resume
Summary : Highly analytical, detail minded Project Manager who has the ability to multi-task and effectively meet project timelines. Strong customer service skills with the drive to succeed in challenging environments. Skilled and effective problem solver with high standard of quality. Effective team builder, as well as one who has the ability to work independently with minimal supervision. Seeking an opportunity to apply skills in a fast paced environment.
Skills : Research, Communication.
- Designated customer projects to ensure that goals and objectives are accomplished within prescribed timeframe and budget while adhering to applicable regulations and protocol requirements.
- Communicated and drive project timeline, critical path activities and project responsibilities.
- Responsible for managing projects across functional areas and locations within PCI.
- Provided support to quote group by reviewing quotes for accuracy.
- Assisted with customer supply agreements/contracts during project development.
- Assessmented of clinical protocols, study specifications, contracts and other documentation to define packaging and distribution requirements.
- Lead internal project team meetings to ensure customer requirements are met.
Clinical Project Manager Resume
Objective : Registered Nurse, Certified Clinical Research Associate. Skilled in management of clinical studies while utilizing cross-culture teams. Cultivates and maintains strong working relationships. Experienced in technical fast-paced team environments. Proven ability to support and educate medical device companies and support sales team.
Skills : Project, Budgeting, Leadership Development, Management, Healthcare, Presentation.
- Integrated Managed Care provider clinics in Michigan Dual Demonstration and products with linear project segments within 90% of estimated time without sacrificing quality.
- Administered Cross Functional Leadership meetings to reconcile communication breakdown which resulted in 100% participation from all teams and expedited sign offs for completed work.
- Implemented two additional payors/Health Plans to Concerto Health for Medical Management in an Integrated Care Model Guided reconciliation efforts for Member resolution across different plans.
- Developed/designed EHR process flow charts (eClinicalWorks and TruCare for Clinic) staff.
- Consolidated MI efforts to reduce disparate sources of potential conflicting information.
- Reduced resource related costs by 8% - 16% by consolidating correlated tasks and teams.
- Fostered collaborative atmosphere across multiple different personalities Developed new Project artifacts for PMO (Project Charter, Meeting Agenda, R-A-I-D logs etc.), improving implementation process.
Health Care Administration