Business Operations Specialist

The Position

The CDO Site Quality & Compliance Lead supports the implementation of the global CDO site quality and compliance framework by the R/OPUs at the site level. The CDO Site Quality & Compliance lead provides functional expertise for site quality and compliance activities in CDO. This role ensures that clinical trial activities conducted at investigational sites adhere to global standards, regulatory requirements, and internal procedures, thereby safeguarding data integrity, patient safety, and inspection readiness.

Responsibilities  

Accountable for implementation and oversight of the global CDO site quality and compliance strategy that aligns with CDO execution excellence strategy, regulatory expectations and industry best practice. Supports alignment with global CDO, R/OPUs and cross functional stakeholders to ensure effective and efficient site quality and compliance processes are embedded in clinical trials across all therapeutic areas. In collaboration with the Head of CDO Site Quality & Compliance, ensures the CDO site quality and compliance strategy is executable by R/OPU CDO teams.

Quality Oversight:
Supports the CDO site quality and compliance interface between global CDO Regions and R/OPUs, ensuring aligned and consistent execution of site level activities including site identification, qualification and selection; site start-up and initiation; site monitoring and risk-based management; and site closure.
 
Supports CDO quality and compliance oversight activities (as required) including:
• quality reporting and metrics to ensure compliance and efficiency, 
• functional quality assessments, 
• Dear Investigator Letter (DIL) coordination and 
• procedural documents (SOPs and KMEDs) governance, including guidance and review.

Site Monitoring and Quality Assurance:
Collaborates with internal (CDO - e.g. Global Process Owners, CDO R/OPUs and MED QM - e.g. QARMa Team for MQD and Heatmaps, inspection management, audit planning etc.) and external (CRO e.g. IQVIA, Parexel) stakeholders to drive continuous improvement, efficiency and effectiveness of site monitoring activities, ensuring the highest standards of monitoring and quality assurance are embedded in trial management processes via adherence to clinical trial protocols, Good Clinical Practice (GCP), data collection and management standards, and health authority/IRB regulations. 

Supports R/OPU CDO Site Quality & Compliance leads, to ensure alignment and execution of CDO site quality and compliance initiatives, e.g. Functional Quality Assessments (FQA) identification of potential areas and topics, planning of the FQA and coordination with MED QM department representative, as well as supporting R/OPU with outcome analysis and development of feasible actions if required.

Audit and Inspection Readiness:
Collaborates with MED QM and R/OPU CDO Site Quality & Compliance leads to implement at the country and site levels CDO Audit and Inspection readiness activities. Supports R/OPUs with Audit and Inspection preparation, conduct and follow up activities. Supports and assigns CDO CAPA Leads for investigation of non-compliances, audit observations or inspection findings (as required).

Training and Capability Building:
Supports continuous training and upskilling of Clinical Trial Managers (CTMs) and Clinical Trial Coordinators (CTCs) on site quality and compliance expectations, monitoring tools, and evolving regulatory landscapes.  Partners with CDO Vendor Partnerships (as required) to support external training collaboration with CRO partners (e.g. IQVIA, Parexel) responsible for Clinical Research Associate (CRA), Clinical Trial Assistant (CTA), Regulatory Start-up Specialist (RSUS), Contract Negotiator (CN) and Site Activation Manager (SAM) training and performance.

Requirements

- Degree in life sciences, medicine, pharmacy, or a related field.
- Certification in Good Clinical Practice (GCP) and familiarity with ICH E6 (R3) guidelines.
- Additional training or certification in clinical research, regulatory affairs, or quality management is advantageous.
- 5 years of Relevant experience
Communication & Collaboration
- Excellent written and verbal communication skills, with the ability to translate complex regulatory requirements into actionable guidance
- Proven ability to collaborate with internal stakeholders (e.g., Quality Medicine, Regulatory Affairs, Medical Affairs) and external partners (e.g., CROs, investigators)
Other Desirable Attributes
- Strategic mindset with a proactive approach to identifying and mitigating compliance risks
- Comfortable working in a matrix environment and managing ambiguity
- Passion for continuous improvement and operational excellence

Total Rewards