Clinical Project Manager
clario costa rica
📍 Remote🌐 Remote🕐 1mo ago🔗 workday
Job Description
****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