Senior Manager, Clinical Data Standards

Ipsen•Paris, TX

60d•Hybrid

About The Position

The Senior Manager, Clinical Data Standards will lead the strategic development, implementation, and governance of clinical data standards across the Research & Development division. This role ensures compliance with CDISC standards (CDASH, SDTM, ADAM) and global regulatory requirements, supporting consistent, high-quality data from collection through to submission-ready databases. As a senior leader, the Senior Manager will drive cross-functional collaboration, oversee external service providers, and mentor internal teams to foster excellence in data standardization. The role also includes active engagement with external industry groups such as the CDISC user community, participation in regulatory forums, and attendance at scientific congresses. These interactions support thought leadership, ensure alignment with evolving standards, and bring innovative practices back into the organization to continuously improve data quality and operational efficiency.

Requirements

Minimum 8-10 years of experience in clinical data management or standards
Deep understanding of CDISC standards (CDASH, SDTM, ADaM) and global regulatory requirements.
Proven experience in vendor oversight and cross-functional collaboration.
Strong project management, communication, and stakeholder engagement skills.
Experience with metadata repositories, EDC systems (e.g., Rave), and data governance tools.
Good knowledge of the drug development processes and the biometry processes
Strong interpersonal and influencing skills with a collaborative mindset and ability to build positive relationships across diverse teams and stakeholders.
Excellent communication abilities, both oral and written, with a focus on clarity, accuracy, and customer orientation.
Proactive and supportive attitude, demonstrating reliability, teamwork, and a commitment to helping others succeed in a matrix environment.
Advanced degree in Life Sciences, Data Management, Information Technology or related field.
English (Fluent)

Nice To Haves

Minimum 3 year of experience in a leadership role
Good level of expertise in the use of the data management and statistic software
Familiarity with define.xml, validation tools (e.g., Pinnacle 21), and submission processes.
Familiarity with Non-clinical Data Standards (SEND)
CDISC (CDASH, SDTAM) certifications

Responsibilities

Define and drive the clinical data standards strategy aligned with regulatory and scientific requirements.
Establish governance frameworks for standards development, approval, and lifecycle management.
Lead gap analyses and impact assessments of evolving CDISC and regulatory standards.
Partner with stakeholders across Medical, Global Patient Safety, Early Development, Biostatistics, and Clinical Operations to ensure harmonized data collection practices.
Promote adoption of standards through training, communication, and change management initiatives.
Manage and oversee external vendors responsible for the implementation and maintenance of data standards, including budget review
Ensure timely delivery, quality, and compliance of vendor outputs through KPIs and performance reviews.
Guide the design of CRFs, edit checks, derivations, and metadata in EDC systems (e.g. RAVE) with according to best practices in the industry.
Support development of submission-ready datasets (SDTM, ADAM).
Drive the development and maintenance of metadata repositories and standard libraries.
Manage the implementation of training programs related to clinical data standards, including the development of materials, and coordination of sessions to ensure consistent and effective knowledge transfer across functions.
Provide leadership and guidance to internal data standards team members and contributors.
Mentor junior staff and foster professional development through coaching, feedback, and knowledge sharing.
Champion a collaborative and inclusive team culture that supports innovation and continuous improvement.
Identify opportunities to enhance data standardization processes through automation and technology.
Stay abreast of industry trends and contribute to internal innovation initiatives.
Engage with external industry groups such as the CDISC user community, attend relevant regulatory agency forums, and participate in scientific congresses to stay informed of emerging trends, and bring innovative practices back into the organization