Project Manager, eCOA

Primary Responsibilities

Identifies project guidelines and communication needs by:

• • Reviewing study requirements and response assessment criteria and collaborates with key stakeholders to develop study start-up activities and associated documents.
  • Defining project plans (i.e., timelines, milestones and limitations for project staff)
  • Establishing project reporting schedules • Providing project updates to BD director, Global Services Managing Directors, Sponsor representative(s) on schedule
  • Communicating timely, appropriate project information to project teams, sites, and company/sponsor representative(s)
  
  Performs project analysis and management by:
  • Identifying critical project success factors for tracking, analysis, and reporting
  • Determining needed resources for project completion and communicating needs to appropriate departmental managers.
  • Collaborating with department leaders for appropriate training of those involved with the project toward excellence in successful and timely completion of project.
  • Performing financial tasks including monthly billing, forecasting, project scope reviews and amendments, and pass-through cost management
  • Possessing a thorough understanding of the project contract and totals needed for monthly revenue reporting.
  • Understanding SOPs and working closely with QA for clarification and documentation of deviations
  • Training and maintaining project team knowledge and applications of SOPs.
  • Communicating all protocol clarifications/revisions to project team
  • Coordinating site management of data collection with internal and external teams.
  
  Provides project team leadership by:
  : • Leading by example with professional and collaborative conduct • Developing and delivering team project training
  • Establishing team performance expectations and guidelines
  • Providing input to departmental managers of respective team members’ performance level
  • Analyzing team performance for consistency/quality within established project guidelines
  • Collaborating with the departmental managers for team coaching/mentoring
  
  Supports Business Development efforts by:
  : • Collaborating with BD Director in the development and presentation of company capabilities calls/meetings
  . • Attending professional meeting(s) as Company representative
  • Delivering polished Investigator Meeting presentation projecting solid comprehension of project/protocol and company services
  
  Oversees project close out by:
  • Assisting with coordination of submission activities, as applicable
  • Assisting with initiating and overseeing all project close out activities to completion.
  
  Performs supervisory functions by, if applicable
  • Communicating job expectations
  • Planning, monitoring and appraising job results.
  • Coaching, counseling, and disciplining staff
  • Initiating, coordinating, and enforcing systems, policies and procedures
  • Approving direct reports time sheets, requests for time off and/or overtime • Performing timely performance evaluations of direct reports
  • Coordinating and conducting new hire interviews; facilitating hiring decision • Training new hires on departmental processes and responsibilities
  
  Maintains Quality Service and Departmental Standards by:
  • Reading, understanding, and adhering to organizational Standard Operating Procedures (“SOP”)
  • Establishing and enforcing departmental standards
  • Reviewing and updating company SOPs related
  
  Secondary Responsibilities
  
  Contributes to team effort by:
  
  • Exploring new opportunities to add value to organization and departmental processes. • Helping others to accomplish results.
  • Performing other duties as assigned and deemed necessary. Maintains Technical Knowledge by:
  • Attending and participating in applicable company sponsored training.
  
  Qualifications:
  
  Education:
  • Bachelor’s degree required or commensurate experience level. Educational majors in life sciences, pharmacy, nursing, or other healthcare field highly desirable
  
  Experience:
  • Previous management or project experience in clinical development of investigational medications required.
  • 1-3 years clinical trials experience within a CRO or pharmaceutical research organization required; preferably in a project management related role. • Working knowledge of GCH, ICH guidelines and FDA regulations • Medical Imaging experience a plus
  • Experience working with computer software including Word, Excel, Access and Project preferred.
  
  Additional skill set
  :• Strong interpersonal and communication skills, both verbal and written • Strong organizational and leadership skills
  • Goal oriented • Ability to maintain professional and positive attitude

The duties and responsibi