Specialist External Data Acquisition Specialist (GCC Pharma Client)

Job description

**Role & responsibilities** The Senior Specialist, External Data Acquisition and Delivery (EDAD) is responsible for end-to-end management of non-CRF (Case Report Form) data. Responsible for the development of new or amended low to medium complexity Data Transfer Specifications (DTS) with minimal supervision for assigned studies or Clinical Development Unit (CDU). Perform external data reconciliations between EDC and vendor data systems to ensure data integrity, completeness, and consistency across all data sources. This role ensures the external vendor data is accurately transferred, reconciled against clinical database, and cleaned in accordance with the study protocol and Data Management Plan (DMP). Act as the primary technical point of contact between clinical data management and vendors. Works collaboratively within Clinical Data Management functions, other external stakeholders and External Data Vendors to ensure the delivery of appropriately structured external data as per Regeneron SOPs and best practices. Provides mentoring for less experienced associates. Ensures that all External Data Services activities are performed according to quality standards and regulatory requirements. Partners with External Data Vendors, CRO partners, Clinical Data Management, and cross-functional stakeholders to guide cross-functional teams and ensure compliance with Regeneron SOPs, regulatory requirements, and industry best practices. **JOB DUTIES**:   Responsible for the development of new DTS templates in alignment with CDISC requirements. This includes:   Authoring the DTS in collaboration with stakeholders, ensuring consistency and compliance with the applicable standard Data Transfer Specification templates and processes.   Responding to external data providers and internal stakeholder queries to ensure data will be delivered are complete, in the correct format and structure.   Tracking DTS status across different data types and programs. Ensure DTS development dates are met as per study timelines.   Ensuring external data structure is consistent and compliant with appropriate standard Data Transfer Specification Templates.   Supporting data structure issue resolution for assigned studies.   Liaising cross functionally to facilitate the creation of new test codes.   Processing change requests to update existing DTS for assigned studies.   Support locking and archival of external data.   Provide review of protocol requirements, vendor specifications, and operational data flows with minimal supervision.   Maintenance of all Data Transfer Specification (DTS) documents, ensuring consistency and compliance with Regeneron standards, processes, templates, and timelines.   Provide guidance on External Data Services to CROs, internal stakeholders, and external vendors across assigned data types.   Monitor data trends to identify potential risks to data integrity or protocol deviations early in the study life cycle.   Perform external data reconciliation activities between EDC and vendor data systems across all studies.   Collaborate with Database Development, Study Data Managers, Biostatistics, other internal stakeholders and external vendors to investigate and resolve data discrepancies and ensure alignment between EDC and vendor datasets.   Recommend areas for improvement in External Data Services process and practice.   Ensure external data, associated processes, reconciliation documentation and audit trails meet inspection readiness standards and regulatory requirements (21 CFR Part 11, ICH-GCP). eTMF document maintained for external data on a regular basis.   Track milestones and deliverables, escalate issues and follow resolution as necessary, and communicate portfolio-level updates to all stakeholders. **JOB REQUIREMENTS:**  List knowledge, skills, and abilities required to perform the job.   Experience in managing multiple clinical data types and formats, e.g., biomarker, eCOA, imaging, ECG, PK, genomics, and laboratory data is required.   Basic knowledge of database structures and protocol review as relevant to clinical data management is preferred.   Demonstrates knowledge of all applicable regulations including 21 CFR Part 11, ICH-GCP Guidelines, and CDISC standards for data collection.   Demonstrates basic knowledge of Data Management, External Data processes, and industry best practices.   Proficiency and experience with extracting data into SAS, CSV, and XML formats is required.   Knowledge of EDC platforms (e.g., Medidata Rave, Veeva, Oracle Inform, etc) and experience with external data reconciliation and query processes between EDC and vendor data systems.   Ability to draw from wide-ranging experience to resolve complex issues.   Strategic thinking, creativity, and problem-solving skills   Ability to work effectively with and motivate virtual teams in a matrix environment.   Strong understanding of cross-functional activities   Effective time management to meet objectives.   Good interpersonal, oral, and written communication skills. **Minimal educational requirements:** Required Licenses & Certificates: Society of Clinical Data Management certification recommended **Experience**: • Minimum of 5+ years in External Clinical Data Acquisition/Management with basic knowledge of database structures and CDISC standards within the biotechnology, pharmaceutical or health related industry. **Education**: BS in Science, Health, Mathematics, Engineering, Computational or related field