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
Working conditions:
Travel: 0-20%
Lifting: 0-15lbs
Other: Computer work for long periods of time
EEO Statement
Bioclinica is an equal opportunity employer. Bioclinica evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic
