Clinical Capability Manager

Clinical Capability Manager

Sigma, Inc. is seeking an experienced Clinical Capability Manager to support our client in Athens, GA. This role is responsible for designing, developing, implementing, maintaining, and continuously improving processes and technologies that enable clinical trial teams to efficiently plan and execute clinical studies.

The ideal candidate will have experience supporting clinical operations, project coordination, records management, document control, and regulated environments within the pharmaceutical or life sciences industry.

• Support the design, implementation, maintenance, and continuous improvement of processes and technologies that enhance clinical trial execution.
• Collaborate as a member of capability teams and cross-functional projects or initiatives.
• Build and maintain strong relationships with internal stakeholders, end users, and external vendors in a matrix environment.
• Provide archiving support activities including preparation and management of offsite storage, chain of custody management, client requests, and archival support activities.
• Serve as the document coordinator within the Vault Quality Documents (VQD) document management system.
• Coordinate document reviews, updates, and creation of local SOPs.
• Upload and maintain project-critical documentation including protocols, reports, and amendments.
• Act as liaison between U.S.
  
  -based GI teams and GI Quality Assurance teams regarding controlled document management activities.
• Support audit readiness and inspection preparation activities.
• Generate and distribute document management and compliance reports.
• Assist archivists and perform additional duties as assigned.

• Bachelor's degree required.
• Project Management and/or Records Management experience required.
• Strong proficiency with Microsoft Office Suite.
• Excellent written and verbal communication skills.
• Strong interpersonal and stakeholder management skills.
• Ability to work effectively within cross-functional and matrix organizations.
• Strong analytical skills with the ability to interpret and utilize data for decision making.
• Ability to build strong customer relationships and provide customer-focused solutions.
• Comfortable working in a digital environment and leveraging technology to solve problems and improve processes.

• Previous pharmaceutical, biotechnology, CRO, or life sciences industry experience.
• Experience with clinical trial operations or clinical development support.
• Familiarity with GLP, GCP, and GMP regulations.
• Experience with document management systems such as Vault Quality Documents (VQD), Veeva Vault, or similar platforms.
• Experience supporting audits, inspections, and quality documentation processes.