Manager, Cra's - Tired Of The "road", Bring Your Cra Experience To Supervise Other Cra's
Covance Inc. (Madison, Wisconsin)

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At Covance, you can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance’s impressive history of company stability and growth. We’ve achieved these results by fostering a work environment that encourages, develops and leverages our team’s capabilities.
Covance’s ongoing success offers team members unsurpassed growth and career development opportunities. There is no better time to join us!

Tired of being a "Road Warrior"?  Bring your CRA experience to supervise other CRA's within our Phase I Clinical Research Units.

GENERAL PURPOSE AND SCOPE: The Clinical Research Associate (CRA) Manager is responsible for the overall management and administration of ECD CRAs. In addition, the CRA Manager serves as a resource for internal and external clients and may function as Lead CRA.
ESSENTIAL JOB DUTIES:
• Meets all requirements of the Senior Clinical Research Associate level.
• Assigns CRAs to ECD projects.
• May co-monitor a project to support/train other CRAs.
• Assures implementation of Project Plans related to the Clinical Monitoring responsibilities by CRAs assigned to ECD projects.
• Develops contingency plans and alternate strategies for providing required monitoring services for ECD projects
• Oversees CRA performance, reviews trip reports for content and timeliness and approves expense reports
• Responsible for coordinating initial and on-going protocol, CRF and monitor training.
• Fiscal responsibility for tracking the monitoring expenses against the project budget
• Works with study teams to generate study specific monitoring plans and ICF templates
• May participate in the development of protocols and Case Report Forms
• Oversees the development of the conventions for CRF transcription
• May assist in business development including proposal generation and feasibility tasks.
• May participate in identification and recruitment of investigators, collection of investigator documentation, pre-study qualification visits and site management responsibilities.
• May organize and deliver presentations at Sponsor and Investigator/Initiation Meetings.
• Track progress of monitoring projects and initiate appropriate actions to achieve target objectives.
• Inter acts with internal work groups to evaluate needs, resources and timelines
• Will participate in the development of new clinical monitors i.e., training and co-monitoring.
• Available for travel, 50% of the time, including overnight stays.
• Perform other related duties as assigned.

EXPERIENCE:
• 7 – 10 years of relevant experience (i.e. medical, clinical, pharmaceutical, laboratory, research, or data management.
• 5-7 years of progressive and proven leadership responsibilities in a related business environment.

EDUCATION:
• University/college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure, medical or laboratory technology).
• Current CRA accreditation
• Thorough knowledge of ICH guidelines, GCP and the clinical trial process.
• Thorough knowledge of the drug development process
• Demonstrated ability to independently manage complex clinical projects.
• Ability to work within and lead a project team.
• Ability to work with other Covance business units.
• Excellent planning and organizational skills.
• Excellent verbal and written communication skills
• Ability to negotiate and liaise with clients in a professional manner.
• Excellent study site management skills.
• Good computer skills with good working knowledge of a range of computer packages including Electronic CRF processes.
• Ability to resolve project-related problems and prioritized workload for self and team.
• Basic understanding of statistical programming, data management, and clinical trial report preparation processes.
• Valid Drivers License


At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career.
Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us.