Temp External Data Services Manager

Pay Range: $84.90 - $109.38/hr

Remote Role (US Only)

May require up to 20% travel

12 Month Contract

The External Data Services Manager is responsible for the creation of Data Transfer Specifications (DTS) for assigned studies or Clinical Development Unit (CDU). Works collaboratively within Clinical Data Management and External Data Vendors to ensure the delivery of appropriately structured external data as per Regeneron SOPs and best practices. Responsible for the development of new external DTS templates including but not limited to data from Biomarkers, Wearable Devices, IRT, Imaging and Electronic Clinical Outcomes Assessment (eCOA).

• Responsible for the development of new external DTS templates in compliance with CDISC requirements.
• Lead the development of DTS documents to align External Data Vendors and Research Partners on the required structure for data. 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 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.
• Train stakeholders in the use of the DTS and other supplemental documents.
• Recommend areas for improvement in External Data Services process and practice. 
• Provide external data management oversight to vendors, providing a pathway for functional discussions, partnership level processes & standards, portfolio status, communication, and escalation.
• Mentor junior staff members.
• Provide advanced-level expertise on DTS to CROs, Internal REGN teams and External Vendors. 
• Fulfill the SME role for 1 or more data types. Develop and deliver training. Provide ongoing support for Clinical Data Management and key stakeholders (as applicable).
• Contribute to the development of SOPs, Work Instructions, Guidance Manuals, and other External Data Service Tools.
• Track milestones/deliverables, escalate and follow to resolution as necessary

• Experience in managing multiple clinical data types and formats, e.g., biomarker, eCOA and imaging data is required.
• Robust knowledge in Biomarker data types and/or Imaging data for oncology and non-oncology studies is a plus.  
• Strong knowledge of database structures is preferred.
• Demonstrates broad knowledge of all applicable regulations including: 21 CFR Part 11, ICH-GCP Guidelines and CDISC standards for data collections.
• Demonstrates advanced knowledge of Data Management / External Data processes and industry best practices.
• Advanced knowledge and experience with extracting data into SAS, CSV, and XML formats is required.
• Demonstrates the ability to discuss complex issues of all aspects of External Data activities with manager and recommend potential solutions. 
• Demonstrates the ability to recommend best practices or new process to meet objectives.
• Ability to draw from wide-ranging experience to resolve complex issues.
• Strong problem solving and project management skills required.
• Ability to work effectively with virtual teams in matrix environment.  
• Strong understanding of cross functional activities.  
• Proven problem-solving skills.  
• Strong ability to manage multiple and varied tasks with enthusiasm, prioritize workload with attention to detail.  
• Effective time management to meet objectives.  
• Excellent interpersonal, oral, and written communication skills.  
• Ability to adjust in a fast-paced environment with tight timelines.

May require up to 20% travel

This is a contract position at Regeneron with Magnit Global being the Employer.

To do our best work we need different viewpoints.  Therefore, we celebrate diversity and embrace inclusion. As an equal opportunity employer, we are dedicated to building a team that represents a variety of backgrounds, perspectives, and skills.  We strive to ensure that we maintain a positive and enriching work environment for all.

W2 only, no third party solicitation