Project Manager

3 weeks ago

Trenton, United States CareerBuilder Full time

Project Manager (Clinical Endpoint/Adjudication) page is loaded **Project Manager (Clinical Endpoint/Adjudication)**
**Project Manager (Clinical Endpoint/Adjudication)**
locationsPrinceton, NJ

time typeFull time

posted onPosted 13 Days Ago

job requisition idR8903

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. Its only through our people that we can continue to innovate technology that will shape the future of clinical trials.
We are investing resources to create an environment our people are proud to be a part of. We want people who know their efforts are valued. This in turn leads to fantastic customer service and allows us to transform patients lives.
****Primary Responsibilities****
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 APMs 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 APMs, 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
****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:
* Bachelors degree required or commiserate 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
* 5-8 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
* Experience working with computer software including Word, Excel, Access and Project preferred
Additional Skills:
* Works independently with little to no supervision or oversight, required
* Ability to manage projects with increased complexity
* Ability to delegate power and authority to a person acting as a representative
* Strong client management to minimize non-standard sponsor requests and escalations
* 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.
Collaboration, Continuous Learning, Critical Thinking, Organizational Awareness, Results Orientation, Service Orientation

Clario delivers the leading endpoint technology solutions for clinical trials. Through experience gained from over 19,000 clinical trials delivered in support of 870 regulatory approvals, Clario fuses scientific expertise and global scale into the broadest endpoint technology platform to enable pharmaceutical, biotech and medical device partners to transform lives. Through Trial Anywhere, Clario has mastered the ability to generate rich evidence across all trial models: decentralized, hybrid and site-based clinical trials. With 30 facilities in nine countries across North America, Europe and Asia Pacific, Clarios global team of science, technology and operational experts has been delivering the richest clinical evidence for nearly 50 years.

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