Are you an experienced Project Manager and interested in a rewarding career opportunity with Project Management, Clinical Research and Technology combined?
Our Specialty Solutions operations are growing, and with big ambitions and a clear vision for the future, now is the time to join Clario as a Clinical Project Manager in Hungary.
What we offer:
What you will be doing:
As a Clinical Project Manager for Clario Specialty Solutions, you will be responsible for defining and overseeing project guidelines and communication needs, ensuring successful project start-up, and establishing comprehensive project plans. Your role includes coordinating detailed project analysis, managing financial tasks, and ensuring adherence to SOPs, while leading and training project teams to achieve excellence. You will collaborate closely with stakeholders, providing updates and ensuring timely communication. Additionally, you will support business development efforts and oversee project close-out activities. Supervisory duties involve training new hires and maintaining high-quality service and departmental standards. This position demands strong leadership, analytical skills, and a commitment to successful project delivery.
Identifies project guidelines and communication needs by:
Reviewing study requirements and endpoint definitions 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:
Works on complex detailed projects that require in depth analysis and understanding
Identifying critical project success factors for tracking, analysis and reporting
Communicates needed resources for project completion to Director, CPM
Collaborating with department leaders for appropriate training of those involved with the project toward excellence in successful and timely completion of project
Participates in 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
Coordinating selection and management of the Endpoint Adjudication committee members
Conducts project/ system training to committee members
Provides project team leadership in managing project load and allocates work to APM’s by:
Leading by example with professional and collaborative conduct
Developing and delivering team project training
Reinforcing team performance expectations and guidelines
Providing input to departmental managers of respective team members’ performance level
Providing feedback to Director, CPM on 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 to APM’s, Project Coordinators
Participating in new hire interviews; provide feedback as directed
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
What we look for:
Bachelor’s degree required or commiserate 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
5 + years clinical trials experience within a CRO or pharmaceutical research organization required
Working knowledge of GCH, ICH guidelines and FDA regulations
Clinical Endpoint /Adjudication experience is considered a plus but is not essential
Experience working with computer software including Word, Excel, Access and Project preferred
At Clario, we put people first, always. We are united and driven by patients, committed to making a difference, and we are always looking for the best talent to help us transform lives. We value the contribution each of our people brings. It’s only through our people that we can continue to innovate technology that will shape the future of clinical trials.