Specialist I, Process & Quality, Project Delivery Office

Job Overview:

At times, under the direction of Associate Manager level or higher, will provide support and facilitate the developing and implementing clinical/project/start-up management methodology standardization. Help in driving continuous improvement/operational excellence across CDCS. Support initiatives to improve quality, efficiency, and user experience in how the company conducts business and measures performance. Assist in change management activities and departmental management as the company delivery platform evolves. Support Company initiatives as appropriate.

Summary of Responsibilities:

• Perform position duties with autonomy and sound judgment.
• Manage central repository(ies) (i.e., SharePoint); posting items as requested/needed.
• Provide support for meetings such as scheduling, agenda distribution, slide consolidation, meeting hosting, meeting recording posting, etc.
• Provide support for onboarding of new staff to DE -equipment ordering, CV/Job Description posting, etc.
• Provide support to DE initiatives and projects as requested.
• Support the department with various logistical needs, such as: managing distribution lists, CV updates (format QC/posting), Job Description updates (role verification/posting), expense report approvals.
• Support department project needs in areas such as special events and communications to department staff.
• Prepare and deliver communications up to Departmental level.
• Coordinate and support the delivery of Departmental training delivered remote or face to face.
• Help prepare and manage functionally managed and Controlled Documents.
• Triage questions and trouble-shoot issues for internal customers.
• Run reports, sort information, and analyze data as requested.
• Collaborate with other Administrative Support staff in Company regarding ways that the function can best support the Company.
• Effectively fulfill the responsibilities for Executive Assistants during absences of the incumbent.
• All other duties as needed or assigned.

Qualifications (Minimum Required):

• University/College Degree (Life Science preferred), or certification in an allied health profession from an appropriate accredited institution (Ex: Nursing certification, Medical or laboratory technology).
• Equivalent practical working experience may be considered in lieu of this recommendation (i.e., 2+ years’ experience within the clinical research industry).
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required):

• 2-4+ years in a drug development, Pharmaceutical or Administrative position including working knowledge of the ICH-GCP guidelines and all other applicable guidelines and regulations.
• Demonstrated ability to perform all duties with an emphasis on customer service, follow-up, and professionalism.
• Ability to establish and maintain effective working relationships with other employees.
• Demonstrated ability to adapt to frequently changing processes.
• Strong organizational and time management skills.
• Experience working in a Virtual Setting.
• Experience in medical setting, the pharmaceutical or clinical research industries.
• Knowledge of Microsoft operating systems and experience with Microsoft Office software, especially Word, Excel, PowerPoint, MS SharePoint.
• Knowledge of Communication software including Webex and MS Teams.
• Ability to learn new programs with minimal instruction.
• Competence in organizing and maintaining multiple personnel schedules.

Preferred Qualifications Include:

• Some Clinical Research Experience preferred.

Physical Demands/Work Environment:

• Standard office and/or home office based working conditions.
• Candidate should be able to work in shifts if business demands for it.

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