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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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Associate Manager

Based in our Maidenhead office or in any of our locations across Europe, Covance are looking for an Associate Manager – Document Review and Maintenance to join our growing Study Start-Up team. This position can be seen as a fantastic development opportunity for Study Start-Up professionals who want to progress their career to project management level. It is also open to experienced CRAs who have a lot of start-up experience and want to continue their career in this direction.

About the opportunity

As a Document Review and Maintenance Associate Manager you will be part of an enthusiastic global service group involved in the delivery of the Global Site Services (GSS) component of assigned studies globally.

You will be responsible for review of the required investigator documentation and study documents for a study and ensuring that the documents meet the specifications required by local regulations, EU Clinical Trial Directive, ICH-GCP, FDA regulations (for IND studies) and/or the study sponsor working with investigative sites, CRAs and Ethics committees (EC) and you will be responsible for site start up and site maintenance.

Essential Job Duties:
Project management responsibilities include
o Liaise with Sponsor and Covance Regulatory Submissions regarding document submission requirements
o *Serve as client primary contact for areas assigned by PM/PD.
o *Act as primary contact for clients and clinical operational teams regarding GSS related issues during the maintenance phase of assigned projects
o Leadership of the GSS project team as directed by PM/PD as required including maintenance and escalation of items in ADI log.
o Contribute to improvements to enhance the efficiency and the quality of the work performed on assigned projects.
o Meet/exceed client satisfaction expectations.
o Follow defined issue escalation process and Covance’s Corrective Action Issue Resolution (CAIR) process.
o Understand and follow project specific and GSS policies and procedures
o Develop and maintain relationships with assigned clients.
o Track project and departmental required metrics.
o Participate in internal review meetings.
o Assist in the management and tracking of resource needs and contribute to contingency planning for key resources.
o Assess impact of scope and / or timeline changes on resource requirements, work flow priorities
o Interpret billing guidelines for functional area.
o Under direction of PM/PD, review project progress against financial milestones using applicable financial systems.
o Follow-up with in-country teams regarding projected IRB / IEC approvals to expedite approval of protocol amendments
o Follow-up with in-country teams regarding expected receipt of amended investigator documentation
o Assist in-country teams in the preparation of applications to applicable IRB/IECs during the maintenance phase of assigned projects.
o Coordinate training and development of staff in Global Site Services processes and requirements specifically related to quality of Investigator Package and country and site-specific Informed Consent development processes.
o Resolution of more complex informed consent by exercising advanced judgment when interacting with assigned team members
o Management of GSS team to assure document tracking information is appropriately included and updated in the applicable Clinical Trial Management System (for example, Site Information Module of Trial Tracker).

• University/college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.
o In lieu of the above requirement, candidates with a High School Diploma or equivalent and a minimum of 6 years work experience with investigator package/essential documentation including a strong working knowledge of the ICH guidelines will be considered.
• Working knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries.
• Thorough understanding of the drug development process.

Minimum Required:
• Minimum of four (4) years of relevant clinical research experience including a strong working knowledge of the ICH guidelines and demonstrated skills and experience with review and maintenance of investigator package/essential documentation.
• Comprehensive understanding of applicable regional regulatory requirements
• Strong networking abilities and an ability/willingness to work with internal and external stakeholders across the globe
• Ability to work with minimal supervision.
• Good planning and organization skills.
• Good computer skills with good working knowledge of a range of computer packages.
• Excellent verbal and written communication skills.
• Ability to lead and develop junior staff.
• Ability to understand and work with financial information.
• Ability to resolve project-related problems and priorities workload for self and team.
• Ability to work within a project team.
• Ability to work efficiently and effectively in a matrix environment.

There is a difference in Covance.
Covance is one of the fastest growing global CROs in 2012.
Covance has been recently ranked fourth in the Health Care Pharmacy industry in Fortune Magazine’s annual list of the World's Most Admired Companies.
In 2011, there were 1,021 companies with at least $2 billion in revenue. COVANCE was one of only 26 that grew revenues for four consecutive quarters… That’s growth in action!

There's a Difference in a Covance Career.

Finding a good job is one thing. Finding a great job where you feel valued and rewarded for your hard work is something else entirely. At Covance, we're making it easier for study start-up professionals to find great jobs and make a meaningful difference in their careers.

• You will work on the most relevant clinical trials currently carried out in the industry at a global level… your work will be meaningful, helping to deliver life-saving and life-enhancing medicines to people around the world.
• Meaningful = Demanding. This is why we have training systems to support your skills growth… We can offer you career progression in a solid company.
• Demanding deserves good compensation, we can offer you one of the most comprehensive benefits packages in the industry

Become an employee at Covance, where you'll enrich your experience, working among the best and brightest in our industry with the knowledge that choosing Covance was one of the best career decisions you've ever made.

And above all: you will be helping make the miracles of medicine a reality.
There is no better time to join us!

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Full Time

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