Lead - Clinical Data Management

<p>Clinical Data Management Lead <b style="background-color: inherit;"></b></p><p><p><b style="background-color: inherit;"><br/></b></p><p><b style="background-color: inherit;">Role Overview:</b></p><br/>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.<br/><br/><b>Key Responsibilities:</b><br/><br/>- Act as the primary subject matter expert for study-level external and third-party clinical data acquisition activities.<br/><br/>- Lead planning and execution of external data setup, including startup, ongoing study support, and closeout activities.<br/><br/>- Develop and manage external data transfer agreements in alignment with internal standards to support downstream data integration, analysis, and reporting.<br/><br/>- Provide strategic guidance on infrastructure and processes for ingesting external data into enterprise clinical data pipelines.<br/><br/>- Oversee validation, quality review, and integration of all third-party data generated during clinical trials.<br/><br/>- 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.<br/><br/>- Support regulatory submission readiness and represent the Clinical Trial Tools & Technologies (CT3) group during inspections, audits, or regulatory inquiries as needed.<br/><br/>- 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.<br/><br/>- Ensure accurate, complete, and timely filing and maintenance of third-party data documentation within the Trial Master File (TMF).<br/><br/>- Follow established SOPs and contribute to the review and continuous improvement of procedural documents to maintain compliance with regulatory and industry standards.<br/><br/>- Review and approve deliverables from external partners, ensuring quality, compliance, and adherence to timelines.<br/><br/>- Proactively identify risks and issues, escalating concerns to CT3 leadership when required.<br/><b><br/></b><b>Required Skills & Experience</b><br/><br/>- Strong understanding of FDA, ICH, and global regulatory requirements, along with industry best practices and quality control standards.<br/><br/>- Proven experience supporting clinical trials across multiple phases of drug development.<br/><br/>- Extensive hands-on experience managing and integrating external or third-party clinical data.<br/><br/>- Demonstrated ability to lead study-level discussions, negotiations, and agreements related to data transfer and integration.<br/><br/>- Excellent communication and collaboration skills, with the ability to work effectively across cross-functional teams with moderate supervision.<br/><br/>- Experience or familiarity with FTP tools such as GlobalScape and clinical systems including Veeva CDMS, Elluminate, and Veeva TMF is highly desirable.</p> (ref:iimjobs.com)