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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.
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 for endpoint adjudication
- Assists the Clinical Endpoint Project Manager in the development of the quality control and query process for endpoint adjudication
- Communicating timely, appropriate project information to project teams, sites and company/sponsor representative(s)
- Works independently across multiple trials performing a quality control of endpoint dossiers
- Assists with site and CRA training for CEC dossier submission and query resolution
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 Manager, CPM
- Collaborating with department leaders for appropriate training of those involved with the project toward excellence in successful and timely completion of project
- Understanding SOPs and working closely with QA for clarification and documentation of deviations
- Training and maintaining project team knowledge and applications of SOPs
- Assists in creation of SOP and WP specifically related to endpoint adjudication
- Assist the Project Manager with site management of data collection with internal and external teams
- Coordinating selection and management of the Endpoint Adjudication committee members
- Assist the Project Manager with 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 Manager, 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
- 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
Maintain quality service and departmental standards by:
- Reading, understanding, and adhering to organizational standard operating procedures (SOPs)
- Assisting in establishing and enforcing departmental standards
Contribute to team effort by:
- Working with internal staff to resolve issues
- Exploring new opportunities to add value to organization and departmental processes
- Helping others to achieve results
- Performing other duties as assigned
Maintain technical and industry knowledge by:
- Attending and participating in applicable company-sponsored training
Qualifications
Education:
- Licensed nursing professional
Experience:
- Previous management or project experience in clinical development of investigational medications required
- 2 years clinical experience
- 2-3 years clinical 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 skill sets:
- Strong motivational skills and abilities, promoting a team-based approach
- Works independently with little to no supervision or oversight, required
- Ability to multi task
- 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.
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