Purpose Summary

Processing Program Lead is the key customer contact and subject matter expert (SME) for TMF document processing operations, responsible for oversight of high-volume document ingestion, classification, indexing, and quality control activities across programs. 

They ensure consistent, high-quality document processing aligned to TMF standards and Good Documentation Practices (GDP), supporting the creation of complete, accurate, and inspection-ready TMFs. 

The role drives operational excellence through oversight of processing metrics, quality trends, and workflow optimisation, establishing a proactive partnership with the customers to continuously improve efficiency, compliance, and data quality within TMF document processing services. 

Primary Duties and Responsibilities 

TMF Document Processing Oversight

• Oversee end-to-end TMF document processing activities (e.g. ingestion, classification, indexing, QC, reconciliation).
• Ensure standardised processing approaches across customer studies and programs
• Identify opportunities to optimise workflows, automation, and throughput.

Processing Metrics & Performance

• Monitor and analyse document processing KPIs (e.g. volume, turnaround times, error rates, right-first-time quality).
• Provide trend analysis and recommend improvements to processing efficiency and quality.
• Implement performance tracking tools and reporting frameworks.

Quality Control & Compliance

• Ensure adherence to Good Documentation Practices (GDP) and TMF Reference Model standards.
• Oversee QC processes (first-pass QC, second-pass QC, audit checks).

• Identify systemic quality issues and implement corrective actions.

• Support audit readiness through robust processing controls and documentation traceability.

Operational Delivery & Workflow Management

• Manage processing pipelines, resource allocation, and workload balancing across teams.

• Ensure SLA adherence and timely delivery of processed documents.

• Drive continuous improvement of processing workflows and standard operating procedures.

Customer Engagement

• Act as primary escalation point for document processing activities.

• Provide insight on processing performance, quality trends, and risks.

• Collaborate with customer stakeholders to align on expectations and continuous improvement initiatives.

Inspection Readiness Support

• Contribute to audit/inspection preparation by demonstrating processing controls and traceability.

• Support CAPA development related to processing errors or gaps.

Policies & Procedures

• Support development and optimisation of SOPs, work instructions, and processing guidelines.

• Ensure procedures reflect best practices in document handling, indexing, and QC.

Training & Mentoring

• Develop and deliver training on document processing standards, systems, and QC expectations.

• Coach team members on quality, consistency, and efficiency improvements.

• Lead document processing teams, including line management responsibilities.

• Oversee recruitment, onboarding, and capability development.

• Monitor resource performance against KPIs and quality targets.

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Experience and Educational Requirements

• Degree level education preferred or equivalent experience.

• Minimum 5 years’ experience in TMF document processing, records management, or eTMF operations within a clinical research environment.
• Minimum 2 years’ experience in People Management.

Minimum Skills, Knowledge and Ability Requirements

In-depth knowledge of:

• Good Documentation Practice (GDP)
• TMF Reference Model (or equivalent)
• Document processing workflows
• QC methodologies
• eTMF systems

Excellent knowledge of:

• Document recognition
• Other clinical/document management systems
• TMF stakeholders
• TMF training
• Inspection Readiness
• Internal and external communication/escalation pathways

Proficient in:

• Verbal and written communication
• Internal and external collaboration
• Coaching & mentoring
• Negotiation/conflict resolution
• Interpersonal interactions
• Working under pressure
• Organisation
• Prioritisation
• Information analysis
• Presenting information

What Cencora offers

​Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.

Affiliated Companies

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned