Manager, External Clinical Data Services

The Manager Clinical Data Services will be responsible for the development of new external DTS templates in compliance with CDISC requirements.

As a Manager, External Data Services, a typical day may include:

• 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 accurate 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.

To be considered for this role, you must meet the minimum requirements:

• Minimum of 7+ years in External Clinical Data Management with a strong knowledge of database structures within the biotechnology, pharmaceutical or health related industry.

• Education: Requires Bachelor’s degree in a Science, Health, Computing, or related field.

• Must have STDM experience.

• Must have External Vendor Experience.

• Clinical Data Services experience.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)