Forward-thinking project manager confident in leading team members, mitigating risks, reaching milestones and managing deliverables. Keeps projects on-track with decisive supervision and quick problem-solving. Persuasive in communicating and negotiating with internal and external team members, vendors and other stakeholders.
Skills
Leadership
Collaboration
Strong, dedicated work ethic
Conflict resolution
Organization
Flexible
Experience
Senior Project Manager, 05/2006 - Current Cardno – Concord, CA,
Serve as the primary contact with the sponsor for all study related items, with oversight of all aspects of trial conduct, from study start-up through close-out in accordance with company and project specific SOPs, guidelines, budgets, timelines and contracts
Assist in the development and design of protocols, CRFs, regulatory documents, study master file, and other study related deliverables
Ensure operational plans are developed consistent with program needs, including but not limited to, the development of communication plans, monitoring plans, project plans, training plan, study timelines and clinical management plans; monitor project progress as compared to established plans and ensure compliance with plans
Facilitate and plan investigator meetings; recruit qualified investigators and assist in budget negotiations
Supervise monitors to ensure site visits occur as scheduled and trip reports are accurate and timely; reports to the Sponsor on study progress
Supervise other staff assigned to programs, including clinical site specialists and regulatory associates
Ensure project training occurs
Serve as a resource to team members for all inquiries and issue resolution for site management, contract budget and remediation, and regulatory document preparation
Lead client teleconferences and/or meetings and present study information at client meetings, bid defenses and UBC monthly project review meetings
Assist in preparation of client proposals in response to RFPs
Ensure project budget is tracked against contract milestones
Duties described for Project Manager and other duties as assigned by management
Oversee all aspects of trial conduct from study start-up through close-out
Manage project per the scope of work and within the contracted budget
Supervise project team
Ensure project is conducted according to UBC and client SOPs
Develop plans to achieve contracted milestones (i.e. Project plan, data management plan, monitoring plan, training plan, communication plan); monitor project progress against the established plans and ensure compliance with plans
Prepare project timelines and prepare or coordinate project development of deliverables
Ensure project budget is tracked against contract milestones
Serve as UBC primary contact with sponsor
Lead internal project and client conferences
Focal point for resolving project team member questions
Supervise assigned staff including clinical research associates, clinical site specialists, regulatory associates
Ensure project training occurs
Negotiate investigator budgets and assist with remediation of contract language
Present study information at bid defenses, client meetings and UBC monthly project review meetings
Coordinate investigator meeting
Assist in protocol development and/or patient/subject consent form
Coordinate and ensure maintenance of Trial Master File
May be asked to perform CSS and CRA duties as needed
Other duties as assigned by management
Clinical Data Manager, 03/2001 - 08/2001 Massachusetts General Hospital – Braintree, MA,
Responsible for all support operation specialists’ duties should the need arise
Serve as UBC primary contact for data on a project
Design or assist in designing databases to meet study needs
Provide input into edit specifications
Coordinate development and validation of study database
Review and provide input to ensure DCTs meet data needs prior to going into production
Provide any interim and final reports as required by the sponsor
Serve as the central person for all report requests
Deliver quality database(s) to stakeholders and communicate any clarifications or details that would affect the data analysis (interim or final) to the statistician
Provide needed status reports to sponsor and/or UBC team
Answer questions on DCTs, protocol, query resolution process on an ongoing basis
Create and maintain the DMP and other core documents for assigned projects
Other duties as assigned by management
Senior Data Coordinator/Clinical Data Coordinator, 02/1998 - 03/2001 Quintiles – City, STATE,
Responsible for the coordination of tasks that provided quality databases for projects according to client requests
Responsible for CRF design and testing
Tested validations and medical coding
Reviewed and cleaned up study data
Resolved problems and database closure using Clintrial 4 and Oracle Clinical
Managed project timelines and milestones
Mentored new associates and other team members
Established and maintained good working relationships with the PK department, statisticians, programming groups, and outside clients
Responsible for the design, development, testing, documentation, implementation, and maintenance of clinical data management collection and reporting systems
Assisted in training new data managers and in CRF design
Responsible for medical coding and the coordination of computer edits
Education and Training
B.S: Health Information Management, Expected in 05/1997 - University of Kansas School of Allied Health - Kansas City, KS GPA:
Resumes, and other information uploaded or provided by the user, are considered User Content governed by our Terms & Conditions. As such, it is not owned by us, and it is the user who retains ownership over such content.
How this resume score could be improved?
Many factors go into creating a strong resume. Here are a few tweaks that could improve the score of this resume:
