JOB SUMMARY

The Manager, Project Administration Support Center (PASC) provides management support and direct supervision to all levels of the Project Administration Specialist (PAS) within the support center. Provides training, consultation, oversees compliance and quality related to administrative and technical support activities of PAS to ensure deliverables are achieved.

Line management of PASC staff, responsibilities including administrative oversight, performance appraisals, and directly supports staff professional development. Ensures staff adhere to the quality expectation and participates in process improvement efforts for the department.

JOB RESPONSIBILITIES

• Performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures (SOPs) Work Instructions (WIs), GCP & ICH Guidelines
• Provides support to PASC leadership in performance/process improvement, identifying operational efficiencies, identifying best practices and continuous improvement opportunities within the PASC.
• Provide expert operational oversight and guidance to support prioritization of activities, review and monitor the work performed, metric compliance, development of contingency plans and risk mitigation strategies to ensure success of the Project Administration Support Center
• Assist in recruiting new staff, including participation in interview process
• Proactively works to ensure staff retention and turnover rates remain within expected levels
• May be involved in assignment of project work, review workload for all direct reports. Ensures staff utilization meets department goal
• May participate in corporate initiatives & Business Unit Project Reviews upon request.
• Responsible for on-boarding, training and mentoring all levels of Project Administration Specialist
• Assist PAS Team with Project Administration Support Center task such as:

o Management of helpdesk tickets requesting and revoking access to systems

o Clinical Trial Management System (CTMS) Site Information Entry

o Providing Study Specific Training Compliance Reports

o Study TMF Filing (i.e. Study Team Curriculum Vitae (CV) , Study Correspondence, Trip Reports, Monitoring Letters, & Telephone Contact Reports (TCRs)

o TMF maintenanceQUALIFICATION REQUIREMENTS (please indicate if 'preferred')

• Undergraduate degree
• Knowledge of GCP/ICH guidelines and other applicable regulatory requirement
• Three (3) years' experience in a clinical and/or medical environment that includes working with TMF or Essential Documents
• Experience with direct line management of staff highly preferred
• Strong organizational and time management skills
• Good communication and interpersonal skills
• Must be able to work independently and in a team environment
• Ability to lead, motivate and work within a team environment
• Electronic Document Management Systems & Clinical Research Experience preferred.
• Ability to handle multiple tasks to meet deadlines in a dynamic environment with high level of accuracy and attention to detail
• Proficiency in the English language both written and verbal
• Demonstrate good computer skills and proficiency in Microsoft Office Suite (Outlook, Word, Excel, and PowerPoint).

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