Clinical Document Control Quality Manager

It’s More Than a Career, It’s a Mission.

Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day.

Our Mission

People who live with cancer – those who work to prevent it, fight it, and survive it – are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world.

Our Clinical Document Control Quality Manager is responsible for actioning and supporting the creation, management, and improvement of documents and procedures used in clinical research for SCRI. This includes process mapping, writing and updating standard operating procedures (SOPs), and ensuring QbD is built into all clinical research processes. This role collaborates across the organization with teams and leaders to ensure processes are clear, consistent, and meet both company goals and industry regulations. As well as recommend and support process improvements. This is a US-based remote position; relocation assistance and sponsorship are not available.

Duties and Accountabilities include and are not limited to:

Document Creation & Management

• Create, revise, and manage controlled document templates

• Ensure proper use of templates, document hierarchy, and formatting standards

• Coordinate document setup in the eQMS

• Maintain the Document Control Index with current versions and effective dates

Periodic Review Process

• Track and initiate periodic reviews

• Coordinate with stakeholders for updates or retirements

• Submit documents for review and approval

• Support compliance and risk assessments

Collaboration & Stakeholder Engagement

• Identify and engage stakeholders for document development or revisions

• Set up collaboration spaces for document drafting and review

• Notify delegated reviewers and approvers, and track status of documents

Review & Approval Workflow

• Conduct compliance and standards reviews

• Identify training needs and approvers

• Finalize documents and communicate implementation plans

• Submit documents for routing and approval

Training & System Support

• Assess training and manage training curricula

• Support user access and role management in eQMS/LMS

• Generate reports for training and document status

• Provide user support and guidance on document control processes

Change Management Integration

• Support change order processing and document uploads

• Coordinate with system administrators for updates

• Ensure alignment with document control procedures

Qualifications needed include:

• Bachelor's Degree required, Master's Degree preferred

• 5+ years' professional work experience with Clinical Trial Regulations (FDA, EMA, MHRA, PMDA) and GCP guidelines required.

• Work experience to include Document Control Standards and ISO 9001 Quality Standard as well as process improvement methodologies.

• Work experience within a pharmaceutical, biologics, CRO or SMO organization.

Preferred Qualifications include:

• ASQ Certified Quality Auditor

• ISO 9001 Certified Lead Auditor

• ACRP Certification

• Lean Six Sigma

About Sarah Cannon Research Institute

Sarah Cannon Research Institute (SCRI) is one of the world’s leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 750 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapi