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Covance Inc.

Covance, with headquarters in Princeton, New Jersey, is one of the world’s largest and most comprehensive drug development services companies, with annual revenues greater than $2 billion, employees in more than 60 countries, and more than 11,000 employees worldwide.    NONCLINICAL DEVELOPMENT(Toxicology, Research Products, Analytical Services)    * Managed 443 compound development programs (>250 IND/CTA enabling), with over 100 different sponsors, which led to 41 IND/CTA applications in 2... Read More

Address      210 Carnegie Ctr Princeton, NJ 08540 (609) 452-8550
Website      www.covance.com/
Holding      No Holding Details

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Line Manager

The Line Manager in Study Start Up has direct supervisory responsibility for Associates and Specialists on the Study Start Up team including the recruitment, training/development, allocation, utilization and performance review of assigned staff. The line manager provides day to day guidance so as to insure the efficient and effective collection and review of pre-study regulatory documents and the accurate completion of Investigator Package Plans subject to measured performance indicators for each staff member.

This is an office based position in Princeton New Jersey, with the option to work from home one (1) day per week.
Education/Qualifications    Required:
• University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
In lieu of the above requirements, candidates with > five (5) years supervisory experience in a health care setting and four (4) years clinical research experience including monitoring in the pharmaceutical or CRO industries will be considered
• Thorough knowledge of ICH Guidelines and GCP, the clinical trial process and a basic understanding of regulatory requirements in other countries
• Understanding of global drug development and the clinical trial project management process, with emphasis on investigator sites, site activation processes and patient recruitment and retention
Experience    Required:
• Minimum of five years relevant clinical research experience in a pharmaceutical company/CRO, including demonstrated line management experience
• Ability to network, negotiate and liaise face to face and remotely with high level internal and external stakeholders in a professional manner
• Demonstrated strong team working and team leadership skills
• Ability to manage multiple competing priorities and projects without supervision, including strong communication, planning & organizational skills
• Ability to inspire and lead by example and motivate teams to seek solutions and get results
• Abilities to review/analyze and report relevant data
• Abilities to review analyze and report interpret protocols and regulatory documents
• Strong computer skills with an ability to understand, access and leverage technology alternatives
• A working knowledge of ICH GCP, US FDA regulations, regulations applicable to local office, guidelines, and practices regarding Good Clinical Practices.

• 3 years Clinical Research Project Management experience.
• Demonstrated Site Services experience
• Demonstrated Regulatory, GCP or QA experience.

Other Job Information

Vacancy type:

Full Time

Contact Mode:

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Contact Name:

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Job Duration:

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