[Hiring] Clinical Data Manager @Fortrea

Role Description

The Clinical Data Manager, Third-Party Data Acquisition (TPDA) will work within a sponsor-dedicated model, partnering closely with sponsor stakeholders, study teams, external data vendors, and cross-functional functions to support the acquisition, integration, and oversight of third-party clinical trial data. This role specializes in non-EDC clinical data acquired from third-party vendors and is responsible for supporting the integrity, compliance, quality, and timely delivery of external clinical data throughout the data lifecycle for assigned studies.

• Serve as the study-level Third-Party Data Acquisition subject matter expert, supporting the acquisition and integration of non-EDC clinical data from external vendors.
• Manage TPDA deliverables across assigned studies, supporting data integrity, quality, compliance, and timely delivery throughout the data lifecycle.
• Perform planning, setup, transfer, and acquisition activities for third-party clinical data, ensuring alignment with study objectives and applicable regulatory requirements.
• Support end-to-end third-party data integration activities, including validation, operationalization, and ongoing optimization of external data acquisition processes.
• Engage and collaborate with external data vendors to facilitate alignment on study requirements, processes, expectations, deliverables, and issue resolution.
• Monitor external data deliverables across assigned studies and vendors to identify, resolve, and help prevent inconsistencies in processes and adherence to applicable standards.
• Perform study-level work prioritization, issue resolution, and vendor coordination, escalating complex issues as appropriate.
• Collaborate with cross-functional stakeholders to support study objectives, alignment, and informed decision-making.
• Represent TPDA in applicable study team meetings and serve as a key point of contact for third-party data acquisition activities.
• Apply knowledge of clinical data standards, including CDISC, SDTM, and ADaM, data governance practices, and diverse data formats and structures associated with non-EDC technologies.
• Work effectively with diverse third-party vendor types, technologies, and data acquisition requirements across clinical studies.
• Support quality, compliance, audit readiness, regulatory inspections, and audits related to TPDA activities.
• Provide training, guidance, and knowledge sharing on study-specific and vendor-specific TPDA considerations and processes, as appropriate.
• Identify opportunities to improve TPDA processes and support the implementation of innovative solutions.
• Manage multiple concurrent studies with different external data acquisition requirements across therapeutic areas and development phases.
• Participate in departmental and process improvement initiatives as assigned.

Qualifications

• Bachelor's degree in Life Sciences, Health Sciences, Information Technology, or a related discipline, or equivalent relevant experience.
• Fluent in English, both written and verbal.
• Strong communication and collaboration skills with the ability to work effectively across functional groups and with external stakeholders.
• Strong attention to detail and commitment to quality and compliance.

Requirements

• 3-5 years of experience in Clinical Data Management and/or the drug development process, preferably with experience involving cross-functional interfaces with Data Management.
• Experience with the acquisition, integration, and oversight of external clinical data from third-party vendors, including supporting vendor relationships and data quality.
• Understanding of end-to-end third-party data integration processes and the lifecycle of externally acquired clinical trial data.
• Solid understanding of clinical trial processes, clinical study documentation, ICH-GCP, global regulatory requirements, industry standards, and quality control principles.
• Understanding of clinical data standards and data governance practices applicable to externally acquired clinical data.
• Experience collaborating with external vendors and cross-functional clinical study stakeholders.
• Strong project management, organizational, analytical, and problem-solving skills, with the ability to manage multiple priorities and concurrent studies.
• Ability to identify and resolve data acquisition and delivery issues and appropriately escalate complex issues.
• Effective communication skills and demonstrated ability to collaborate across functional groups.
• Proficiency with Microsoft Office applications.

Preferred Qualifications

• Experience working within a sponsor-dedicated or Functional Service Provider (FSP) model.
• Experience working with multiple types of non-EDC clinical data, external vendors, data formats, or clinical data technologies.
• Knowledge of CDISC, SDTM, and ADaM standards and their relationship to clinical data acquisition and integration.
• Experience supporting vendor coordination or oversight for externally acquired clinical trial data.
• Experience with TMF systems and clinical data platforms.
• Experience supporting regulatory inspections or audits involving third-party clinical data.
• Experience managing external data acquisition requirements across multiple studies, therapeutic areas, or development phases.

Work Environment

• Office and/or home-based work environment, as applicable.
• Ability to collaborate effectively within global, virtual, and cross-functional teams.