Associate Project Manager - Leeds Phase I Unit
Covance is a market leading Contract Research Organisation supporting the worlds Pharmaceutical and Biotechnology business in bringing new medicines and to market. We have over 11,500 employees in over 65 countries and a turnover in excess of $2bn.
At our Phase I Clinical Pharmacology Unit in central Leeds, we are currently recruiting an Associate Project Manager. We are happy to consider both external applicants and also applicants internally who wish to transfer to this department. All applications but be logged on our application portal by end of day, 20th August 2012.
The Associate Project Manager oversees and manages Clinical Pharmacology trials conducted at Covance clinical research sites under leadership direction. Responsibilities typically include contributing to the development and management of the protocol, budget, timeline and quality guidelines for projects, thereby ensuring that expectations are met while identifying and mitigating risks. The Associate Project Manager also compiles and drives documentation for the project, ensuring the accuracy and quality of regulatory data. The Associate Project Manager will be responsible for managing the project team with support as needed from a more senior Project Manager.
Essential Job Duties:
• Lead the core project team
• Project manage routine studies at a single Covance site
• Ensure effective cross-functional teamwork among project team members including both internal and external ancillary services.
• Manage and track project resource needs and contribute to contingency planning for key resources.
• Create required project plans. Implement and monitor progress against project plans and revise as necessary.
• Monitor project schedule and scope to ensure both remain on track. Implement and follow pre-approved procedures for any deviations.
• Serve as client primary contact.
• Contribute to improvements to enhance the efficiency and the quality of the work performed on assigned projects.
• Meet/exceed client satisfaction expectations.
• Present at external and/or internal meetings
• Assist in ensuring that all staff allocated to assigned projects adhere to professional, SOP, and specific GCP and ICH standards.
• Follow defined issue escalation process
• Monitor and control the risk plan and provide ongoing oversight to ensure mitigation plans are in place and working.
• Meet financial performance targets for the assigned projects and proactively identify out of scope activities and execute necessary work scope change orders.
• Ensure that monitoring reports and monitoring visits are completed in a timely manner.
• Establish working relationships with client project teams which result in client satisfaction, operational excellence and thereby increase potential for repeat business.
• Contribute and participate in the delivery of presentations for new business, as required.
• Track client project metrics.
• Ensure that internal project review meetings are conducted as needed.
• Perform other duties as assigned by management.
Education / Qualifications Required:
• 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.
• Acceptable: In lieu of the above requirement, candidates with five or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered.
• Knowledge of ICH Guidelines and GCP including a basic understanding of international regulatory requirements for the conduct of clinical development programs..
• Thorough understanding of the drug development process.
Experience Required:
• Typically a minimum of four years of relevant clinical research experience in a pharmaceutical company/CRO including study management and/or study/project coordinator experience.
• Experience in managing projects in a virtual environment.
• Understanding of applicable regional regulatory requirements.
• Ability to work with minimal supervision.
• Good communication, planning and organization skills.
• Good computer skills with good working knowledge of a range of software packages.
• Ability to understand and work with financial information.
• Ability to resolve project-related problems and prioritize workload for self and team.
• Ability to work within a project team
• Ability to liaise with clients in a professional manner
• Ability to work efficiently and effectively in a matrix environment.
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!