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Start-up Manager

COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.

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.
This is your chance to become part of a team that helps to bring miracle of medicine to market sooner.
About the Job
Oversee the activities of Start-up functional leads (Global Site Services Lead, Regulatory Lead, Drug and Documentation Lead)
Act as primary contact for Project Team regarding all start-up activities
Act as primary contact for client regarding start-up activities
Generate a detail GANT for the start up portion of assigned clinical trials in collaboration with Project team and Start-up Leads
Manage progress of project against plans and proactively communicate issues/challenges
Report on progress of start up against plans to project team
Maintain start-up risk/issues log
Establish and manage meetings with start-up leads as required by the project
Coordinate interaction of Start-up leads with client as required
About You
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)
Thorough knowledge of ICH Guidelines and GCP, the clinical trial process and a basic understanding of regulatory requirements in other countries
Ability to network, negotiate and liaise face to face and remotely with high level internal and external stakeholders in a professional manner
Typically 4 - 5 years experience preferably within a clinical research or pharmaceutical company
Proven leadership skills with the ability to inspire and motivate staff within a field based environment
Demonstrated Account Management and business development experience with a previous track record working as a Senior Clinical Research Associate or Clinical Project Manager would be advantageous

We Offer
Covance’s ongoing success offers team members unsurpassed growth and career development opportunities.
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.

There is no better time to join us!

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.
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, patient recruitment and retention

Preferred:
An understanding of aspects surrounding Covance business development and financial control (time and cost estimates, bid defense, contracts)
An understanding of relevant Covance procedures, including Standard Operating Procedures
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 so as to assist in building evidence-based clinical trial strategies
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.
To apply for this position please apply directly to the Covance website www.covancecareers.com quoting ref no:25016.