Global Program Manager

Position Description

Position Summary

The Global Program Manager is responsible for providing Global Operational Leadership and proactive Client Relationship Management to clients for services and operational activities at Xerimis.

Position Reports to

Vice President, Global Programs

Position Supervises

N/A

Essential Duties and Responsibilities

The essential functions include, but are not limited to the following:

  • Primary contact from initial set-up activities and throughout the duration of the global clinical studies for Sponsor and internal teams across multiple services areas
  • Ensure the trial is effectively supported and of the high standard expected
  • Work with a variety of clients on different clinical studies requiring a proactive and flexible approach
  • Ensure appropriate level of support to global clinical studies
  • Ensure deliverables are met and a successful partnership is developed and maintained by sponsor
  • Manage and lead strategic operational aspects of clinical trial projects to ensure timely and coordinated delivery
  • Provide senior level consultation and support within Xerimis and to the sponsor. Update BD on potential future studies (business intelligence)
  • Lead communication between multi-functional teams to define and monitor project milestones and achieve overall project alignment
  • Drive continuous improvement and identify optimal processes for specific partnership opportunities
  • Development and reporting of customer KPIs
  • Provide support for quote and invoicing activities. Take a proactive role in change order management on those studies to which GPM is assigned.
  • Manage issues and lead effective resolution with sponsor
  • Preparation and management of a project plan to meet required milestones
  • Lead meetings with sponsor and internal teams to facilitate project completion. Deliver project within agreed timelines and budget.
  • Manage projects that may reside within single or multiple point of contact for the sponsor and facilitate responses to sponsor questions and observations
  • Primary client communication focal point for project team and client advocate
  • Take on additional assignments for the department, group, or site with support
  • Conduct issue resolution activities for supply aspects of clinical studies (eg packaging, distribution)
  • Track global projects as assigned between US and UK facility within Xerimis
  • Provide support and assistance for sponsor requiring Qualified Persons release/certification of supplies
  • Create overall draft timelines pre-proposal to destruction
  • Generation and upkeep of pertinent sections of CSPL with the understanding that this is a jointly owned document requiring input from all departments
  • Responsible for client kick-off meeting. Additional kick-off meeting for QP declaration if needed.
  • Responsible for internal kick-off meeting
  • Develop close-out strategy for study
  • Provide visibility of progress to internal and external stakeholders
  • Provide notification of milestone completion to finance for billing
  • Liaise between sponsor and QP for early information gathering for QP Declaration
  • Establish and or confirm the client Project Management / Clinical Supplies Management support needs
  • Responsible for compiling and issuing the communication plan / charter
  • Responsible for setting up routine meetings with Client
  • Responsible for setting up meetings within Xerimis as required
  • Responsible for compiling, issuing, and storing meeting minutes
  • Responsible for escalation of points of concern regarding timing / contractual issues
  • Create and share study Dashboard with Client / Xerimis management
  • Take part / organize quarterly / annual business review with Client
  • Understand and where possible incorporate the client’s needs into proposal activity

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • Bachelor’s Degree or equivalent work experience
  • Minimum of 5 years Pharmaceutical Clinical Supply Management or related experience strongly preferred
  • PMP certification preferred
  • All candidates must have a thorough understanding of GDP/GMP guidelines
  • Strong communication skills
  • Solid leadership skills
  • Strong sponsor relations and interpersonal skills
  • Excellent listening skills
  • Attention to detail
  • Effective experience in project management to include global clinical trials, experience with IRT systems, packaging and distribution
  • Extensive use of internet resources and databases
  • Strong working knowledge of Power Point, Excel, Word, and Outlook
  • Strong working knowledge of validated drug supply forecasting systems a must

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions. While performing the duties of this job, the employee is regularly required to talk or hear. While performing the duties of this job, the employee is exposed to an office environment and may be exposed to the warehouse and operations (packaging) environment including occasional exposure to elements such as odor, noise, dust, heat, cold or chemicals. The noise level in the work environment is usually moderate.

Note

This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an “at will” relationship.

The company is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable.

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