Reference #: R14522
Clario is a 50+ year old company that delivers industry leading clinical trial endpoint technology solutions. The future of clinical trials is vibrant, with new technologies revolutionizing what's possible. From new trial modes to faster and integrated evidence and findings, our innovative clinical trial solutions mean we can unlock better evidence.
What we offer:
Competitive compensation
Medical, dental, and vision insurance beginning Day 1 of employment
Flexible work schedules
Attractive PTO plan
What you'll be doing:
Identifying 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)
Performing 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
Providing 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
Supporting 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
Oversee project close out by:
Assisting with coordination of submission activities, as applicable
Assisting with initiating and overseeing all project close out activities to completion
Performing 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
Maintaining 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
Contributing 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
Maintaining Technical Knowledge by:
Attending and participating in applicable company sponsored training
What we are looking for:
Bachelor's degree required or commensurate experience level. Educational majors in life sciences, pharmacy, nursing, or other healthcare field highly desirable
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
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
Clario is an equal opportunity employer. Clario 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.
ERT is an equal opportunity employer and all qualified applicants receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.
