The Global Program Coordinator is responsible for assisting the team in providing Global Operational Leadership and proactive Client Relationship Management to clients for services and operational activities at Xerimis.
Position Reports to
Global Program Director
Essential Duties and Responsibilities
- The essential functions include, but are not limited to the following:
- Assist GPM/CSM consultant with initial set-up activities and throughout the duration of the global clinical studies for Sponsor and internal teams across multiple services areas
- Assist GPM/CSM consultant in ensuring the trial is effectively supported and of the high standard expected
- Assist GPM/CSM consultant in ensuring deliverables are met and a successful partnership is developed and maintained by sponsor
- Assist in driving continuous improvement and identifying optimal processes for specific partnership opportunities
- Assist in providing support for quote and invoicing activities.
- Assist GPM/CSM consultant in managing issues and providing effective resolution with sponsor
- Assist in preparation and management of a project plan to meet required milestones
- Assist with meetings with sponsor and internal teams to facilitate project completion and delivering project within agreed timelines and budget
- Take on additional assignments for the department, group, or site with support
- Assist with issue resolution activities for supply aspects of clinical studies (eg packaging, distribution)
- Assist in tracking global projects as assigned between US and UK facility within Xerimis
- Assist GPM/CSM consultant provide support and assistance for sponsor requiring Qualified Persons release/certification of supplies
- Assist in creation of overall draft timelines pre-proposal to destruction
- Assist in generation and upkeep of pertinent sections of CSPL with the understanding that this is a jointly owned document requiring input from all departments
- Assist in setting up client kick-off meeting and additional kick-off meeting for QP declaration if needed.
- Assist with internal kick-off meetings
- Assist in developing a close-out strategy for study
- Provide notification of milestone completion to finance for billing
- Assist with compiling, issuing, and storing meeting minutes
- 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
- 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.
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.