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Clinical Project Manager - United States  

Company managed [?] Still accepting applications

Posted on : 02 May 2017

Project Description

Tracking Code
1622-050
Job Description

Bioclinica, Inc. is looking for intelligent, creative and dedicated professionals to join our growing team. We are a company that values technical excellence, teamwork and a commitment to success. We employ cutting edge technology to provide our customers with industry leading solutions and are currently seeking to fill the position of Clinical Project Manager to work out of our Newark Office. 

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
  • Establishing clear and measurable project operating guidelines with BD Director and Sponsor representatives
  • Defining project plans (i.e. timelines, milestones and limitations for project staff)
  • Establishing project reporting schedules with BD Director and Sponsor representative
  • Providing project updates to BD Director, 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
  • Developing budget and expense review strategy
  • Creating proactive cost containment strategies and communicating them to project team
  • Reviewing regularly the task/time budget and expenses with team
  • 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
  • Possessing a thorough understanding of the project contract and totals needed for monthly revenue reporting
  • Managing pass through expenses associated with the project

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

  • Communicating job expectations
  • Planning, monitoring and appraising job results
  • Coaching, counseling and disciplining staff
  • Identifying and developing key staff to eventually assume greater responsibility and growth within the company
  • 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
  • Working with upper management in the continued development, coordination and implementation of support functions, processes, training program and evaluation of same

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

Working conditions:

  • Lifting: 0-15lbs
  • Travel: 0-20%
  • Travel: 0-20%Computer work for long periods of time
  • Other: Computer work for long periods of time
Required Skills

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
Required 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

Education:

  • Bachelor’s degree required. Educational majors in life sciences, pharmacy, nursing, or other healthcare field highly desirable
Job Location
Newark, California, United States
Position Type
Full-Time/Regular