Project Manager I, PM COE

Job Overview:

Oversees and manages regional clinical trials under leadership direction. Responsibilities typically include contributing to the development and management of budgets, timelines 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.

Operational delivery Responsible for project delivery with regards to agreed time, scope, cost and quality TEAM COMMUNICATION: Serve as client primary contact for areas assigned by Project Manager (PM), Senior Project Manager (SPM), or Associate Director (PD) Assist in the leadership of the core project team, as directed by PM/SPM/PD to facilitate their ability to lead extended cross-functional project team including the maintenance of timelines in MS Project, creation of PowerPoint presentations and storyboards and maintenance and escalation of items into an ADI log and/or RACT tool Follow defined project issue escalation process and Covance's Corrective Action Issue Resolution (CAIR) process TEAM COMMUNICATION: Provide performance feedback of team members to respective supervisors COST: Interpret billing guidelines for functional area SCOPE: Under direction of PM/SPM/PD, track project progress against financial milestones using applicable financial systems RISK: Under direction of PM/SPM/PD, proactively lead quality control and risk assurance activities to ensure project deliverables are met according to regulatory, Covance and client requirements QUALITY: Assist in the successful design, implementation, tracking and revision of project plans for assigned projects. Assist in ensuring that all staff allocated to assigned projects adheres to professional standards and SOPs Track and maintenance of key project performance indicators for client specified metrics Assist in the management and tracking of project resource needs and contribute to contingency planning for key resources Business Development Contribute and participate in the delivery of presentations for new business, as required Perform other duties as assigned by management Line Management & Talent Development Trains & mentors PM Academy PCs in multiple areas of expertise

 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 In lieu of the above requirement, candidates with five (5) or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered Experience:

Minimum Required:

Minimum of four (4) years of relevant clinical research experience in a pharmaceutical company/CRO.

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

Preferred:

Local project coordination and/or project management experience

On the Job Experience:

Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.

Advanced computer skills (e.g., Microsoft Word, Excel, Project, Access and Power Point)

Ability to work with minimal supervision

Excellent verbal and written communication skills

Ability to set clear expectations for junior staff on projects

Ability to resolve project-related problems and prioritizes workload for self and team

Demonstrated organizational skills and the ability to prioritize multi-tasks

Ability to understand and work with financial information

Basic knowledge of project management processes

Demonstrated ability to work within a matrix system