Project Manager I, PM COE at Covance in Deerfield, IL

Job Overview:

JOB PURPOSE

Leadership of clinical project team during study set up, conduct, and close out

ESSENTIAL FUNCTIONS

Responsible for coordinating and managing contracted ambulant care services in the support of sponsored pharmaceutical and biotech studies. May involve all phases of development and a variety of therapeutic areas.

• Review and interpret protocols and assist in developing ambulant care training manuals for new studies Provide weekly status report for senior management and sponsors.
• Train and manage GlobalCare Country Coordinators in their roles for specific studies to ensure compliance with study requirements and applicable regulations.
• Function as a liaison between sponsor, CRO, study vendors, (e.g., central lab) and Country Coordinators to communicate GlobalCare services and activities
• Respond to sponsor or investigator site queries Review ambulant care documents provided by Country Coordinators or ambulant care Service Providers. Ensure timely provision to the investigator sites, as appli able Resolve data inconsistencies with Country Coordinators
• Update and maintain electronic study data trackers for assigned study(ies)
• Participate in the development and implementation of process improvement initiatives
• Attend Investigators’ Meetings and Country Coordinator trainings
• Participate in project teleconference calls and meetings
• Inventory and track study supplies, as applicable, such as lab kits for home visits
• Comply with ICH/GCP guidelines, patient data protection laws, applicable
• GlobalCare SOPs and study requirements
• Assist with management of Clinical Trial Associates

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.

Responsibilities/Duties

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
• 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

Other duties as may be requested from time to time

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us

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

Experience:

• 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