Jessica Claire
  • , , 100 Montgomery St. 10th Floor
  • H: (555) 432-1000
  • C:
  • Date of Birth:
  • India:
  • :
  • single:

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.

  • Leadership
  • Collaboration
  • Strong, dedicated work ethic
  • Conflict resolution
  • Organization
  • Flexible
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
Project Manager, 08/2001 - 05/2006
Jabil Circuit Grand Junction, CO,
  • 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

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