External Data Services Manager - Pharmaceutical Research Associates : Job Details

The Manager, Data Management - External Data Services will play a critical role in Clinical Development through ensuring the delivery of appropriately structured external data, including but not limited to data from biomarkers, wearable devices, IRT, Imaging and Electronic clinical outcomes assessment - eCOA. The Manager, External Data Services will be responsible for effectively leading and supporting the Global Development Data Management team by serving as the primary contact to other line functions to oversee external data quality control, standardization, and integration for external data.

• Lead the development of Data Transfer Specifications (DTS) documents to align external data providers and research partners on the required structure for new data. This includes:
• Authoring the DTS, responding to external data providers and internal stakeholder queries to ensure data will be delivered in the correct format and structure.
• Track DTS status with external data providers across different data types and programs and ensure data completion dates are met for study timelines and deliverables.
• Ensuring data structure based on the type(s) of data being used is consistent and compliant with appropriate data templates.
• Ensuring data structure is consistent across each data provider and complies with appropriate data.
• Support data reconciliation and data structure inquiry.
• Liaise cross-functionally to facilitate the creation of new tests.
• Participate in the Clinical Study Team as an extended team member.
• Oversee and train in the use of the DTS and other supplemental tools.
• Contribute to improvement initiatives as they relate to external data.
• Ensure study teams adhere to CDISC standards as they relate to external data.
• Comply with all pertinent regulatory agency requirements (Understand clinical protocols and requirements for Biomarkers/Imaging/eCOA data, blinding, and analysis expectations).
• Process change requests to update existing documents.
• Improve templates for existing DTS to ensure data harmonization and downstream usability.
• Provide external data management oversight to vendors, providing a pathway for functional discussions, partnership level processes & standards, portfolio status, communication, and escalation.
• Review and contribute to eCRF and EDC builds as they relate to external data.

• Minimum of 8 years of external clinical data management/programming experience in biotechnology, pharmaceutical or health-related industry and strong knowledge of database structures.
• Expertise in biomarker data types and/or Imaging data for oncology and non-oncology studies is preferred.
• Experience working with multiple data types/formats.
• Experience in managing clinical, biomarker data, eCOA and imaging data.
• Demonstrates broad knowledge of all applicable regulations including 21 CFR Part 11, ICH-GCP Guidelines and CDISC standards for data.
• Demonstrates advanced knowledge of Data Management processes and industry best practices.
• Advanced knowledge and experience with extracting data into SAS, CSV, and XML formats is required.
• BS Major/ Minor (Biology, Computer Science, programming, data management, scientific or analytic discipline or equivalent).