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Senior Project Feasibility Associate

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

Coordinate the delivery of the Global Site Services (GSS) component of assigned studies across a region or globally. Including overall accountability for delivery to time, cost and quality
• Leading the drafting and finalization of Study Plans related to GSS activities
• Responsible for directing day to day work flow of assigned GSS staff in the collection and review of investigator and regulatory documents
• Oversee site start-up activities for studies in which GSS is working with customers: ensure compliance with timelines / milestones for site activation through planning & review of work with individual team members
• Ensuring, through training and quality monitoring, that these documents meet the specifications required by local regulations, EU Clinical Trial Directive, ICH-GCP, FDA regulations (for IND studies) and/or the study sponsor
• May be responsible for line management of GSS personnel: mentoring, performance management: ensuring understanding of project specific and GSS policies
• Works with staff in Operational Strategy & Planning, Business Development and Operations, to provide feasibility data and other relevant data critical to the ability of the organization to develop evidence-based plans for the successful implementation and conduct of global clinical trials
• Provide Covance input into Drug Supplies coordination as applicable, including authoring Clinical Trial Supplies Plan (including liaison with external vendors and clients) and management of labeling requirements.

About You:

University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) with typically 4 years work experience in study start-up activities, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations

In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 6 years work experience in study start-up activities, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations will be considered.

Preferred:
• An understanding of aspects surrounding Covance business development (time and cost estimates, bid defense, contracts)
• An understanding of relevant Covance procedures, including Standard Operating Procedures
• Thorough knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; extensive experience of investigator start-up documents; interaction with operational project teams and investigative sites
• Strong networking abilities and an ability/willingness to work with internal and external stakeholders across the globe
• Excellent communication / writing skills
• Ability to motivate self & others when working under pressure to meet deadlines
• Demonstrated ability to delegate effectively, co-ordinate a team to achieve results
• Detail and process oriented
• Good organizational skills
• Positive attitude and approach
• Strong computer skills with an ability to understand, access and leverage technology alternatives
• Abilities to review/analyze relevant data so as to assist in building evidence-based clinical trial strategies
• Ability to work independently

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.