Job Overview:
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. The Clinical Data Manager, TPDA will perform study-level planning, setup, transfer, acquisition, and oversight activities while ensuring alignment with study requirements, applicable processes, and regulatory standards.
The role requires strong understanding of end-to-end third-party data integration processes, diverse external data formats and technologies, vendor coordination, clinical data standards, data governance, and cross-functional clinical trial delivery.
Summary of Responsibilities
- 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
Minimum Required
- 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.
Experience
Minimum Required
- 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.
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