The External Clinical Data Integration Lead will be responsible for overseeing the end-to-end planning, setup, acquisition, and integration of third-party clinical data at the study level. This role plays a critical part throughout the clinical trial lifecycle-from study startup through closeout-ensuring external data is compliant, validated, and seamlessly incorporated into company clinical data platforms.

Key Responsibilities:

- Act as the primary subject matter expert for study-level external and third-party clinical data acquisition activities.

- Lead planning and execution of external data setup, including startup, ongoing study support, and closeout activities.

- Develop and manage external data transfer agreements in alignment with internal standards to support downstream data integration, analysis, and reporting.

- Provide strategic guidance on infrastructure and processes for ingesting external data into enterprise clinical data pipelines.

- Oversee validation, quality review, and integration of all third-party data generated during clinical trials.

- Partner closely with internal stakeholders such as Clinical Data Management, Clinical Data Engineering, Standards teams, and Study Execution teams to ensure alignment and timely delivery.

- Support regulatory submission readiness and represent the Clinical Trial Tools & Technologies (CT3) group during inspections, audits, or regulatory inquiries as needed.

- Serve as a key point of contact for external vendors and partners, including laboratories, eCOA providers, and technology vendors, as part of the CT3 Third-Party Data Acquisition team.

- Ensure accurate, complete, and timely filing and maintenance of third-party data documentation within the Trial Master File (TMF).

- Follow established SOPs and contribute to the review and continuous improvement of procedural documents to maintain compliance with regulatory and industry standards.

- Review and approve deliverables from external partners, ensuring quality, compliance, and adherence to timelines.

- Proactively identify risks and issues, escalating concerns to CT3 leadership when required.

Required Skills & Experience

- Strong understanding of FDA, ICH, and global regulatory requirements, along with industry best practices and quality control standards.

- Proven experience supporting clinical trials across multiple phases of drug development.

- Extensive hands-on experience managing and integrating external or third-party clinical data.

- Demonstrated ability to lead study-level discussions, negotiations, and agreements related to data transfer and integration.

- Excellent communication and collaboration skills, with the ability to work effectively across cross-functional teams with moderate supervision.

- Experience or familiarity with FTP tools such as GlobalScape and clinical systems including Veeva CDMS, Elluminate, and Veeva TMF is highly desirable.

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Posted by

Ashutosh Singh

Director of Recruitment at VERIDIC SOLUTIONS PRIVATE LIMITED

Last Active: 09 January 2026

Job Views:
30

Applications: 1

Recruiter Actions: 0

Posted in

Pharma