Clinical Capability Manager

Acts as the document coordinator in the Vault Quality Documents (VQD) document management system facilitating activities related to coordinating review of, update and creation of local SOPs, upload of project critical documentation and protocols, reports, and amendments. Responsible for designing, developing, implementing, maintaining, overseeing, and continuously improving processes and technologies that empower clinical trial teams to efficiently plan and deliver clinical trials.

Job Title: Clinical Capability Manager
Location: Athens, GA- Onsite
Hours/Schedule: 40 hours a week
Type: 16 Month Contract

Responsibilities

• Responsible for designing, developing, implementing, maintaining, overseeing, and continuously improving processes and technologies that empower clinical trial teams to efficiently plan and deliver clinical trials.
• Contribute as a member of a capability team or as part of a defined project or initiative, collaborating with end users and cross-functional stakeholders, including vendors in a matrix environment.
• Provide archiving support activities according to established procedures, including managing offsite storage, chain of custody, client requests, and assisting archivists.
• Acts as the document coordinator in the Vault Quality Documents (VQD) document management system facilitating activities related to coordinating review of, update and creation of local SOPs, upload of project critical documentation and protocols, reports, and amendments.
• Serve as a liaison between US-based GI teams and GI QA on controlled document management, supporting audit and inspection preparations, and providing regular reports.

Requirements

• Bachelor’s degree with Project Management and/or Records Management experience.
• Proficiency in Microsoft Office Suite.
• Excellent communication and interpersonal skills.
• Previous experience in the pharmaceutical industry and familiarity with GLP/GCP/GMP compliance a plus.
• Ability to actively engage with customers, build strong relationships, and deliver customer-centric solutions.
• Technical proficiency to access information, think creatively, solve problems, and navigate digital environments.
• Ability to generate and analyze data for decision-making based on interpretation.
• Strong relationship management skills with internal and external stakeholders.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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Ref: #568-Clinical