Global Study Data Leader

Job Title: Global Study Data Leader

Location: Morristown, NJ Cambridge, MA

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate Progress.

Global Study Data Leader is responsible for leading the end-to-end data management activities and associated quality deliverables for clinical trials including study set-up, conduct, and close-out, complying with GCP and applicable regulatory guidance. Provide comprehensive data management expertise and support to team members. Coordinate cross functional teams globally to ensure the flawless conduct of a clinical trial. Ensure activities are completed according to agreed standards and timelines and serves as the Data Management representative in the study team.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?​

Main Responsibilities:

Core knowledge, competencies & skills:
· Intermediate:
· Strong Data Management expertise i.e., understanding of Data Management scope and objectives.
· Solid knowledge of the clinical trial development process and understanding of relevant and current regulatory guidelines, Good Clinical Practice (GCP), industry standards, and practices regarding Data Management.
· Solid Clinical Data Management System experience (CDMS & EDC) and understanding of database development/programming concepts.
· Strong collaboration and interpersonal behaviours; manage activities effectively with study team and other DM functions. Establish rapport and collaborates inside and outside the company. Demonstrate flexibility through effective negotiations.
· Strong communication skills; Ensure clear, concise, consistent, and timely communication including risks identification, and escalation.
· Advanced:
· Project management skills
· Learn and adapt quickly when facing new challenges; Ability to think critically and use objective, and pragmatic methods to solve multidimensional problems with effective and timely solutions.
· Mentor and coach new Data Managers on all operational aspects needed for the successful completion of a trial.
· Expert:
· Strong experience in data management outsourcing and vendor management, participate and provide Data Management input at BID defense meetings as needed.
· Be able to present data management topics at CSO level or at a relevant conference.
· Act as mentor for Data Management supports; responsible for the data quality delivered by team member at study level.
· Leadership in driving cultural and structural shifts, shaping company standards in change management excellence

Global Study Data Leader:

• Contributes to the implementation of department initiatives and objectives as well as cross-functional working groups. Implements and oversees processes and coordinates activities in conjunction with the internal team and Clinical Data Delivery Leader continually evaluates processes and applications for improvements.

• Oversee vendor activities to identify risks and ensure that activities are completed according to the SOW, regulations, and with expected quality. Implement quality control strategies and remediations as necessary.

• Ensure that all external data loading and integration activities (Incl. eCOA, IRT, central labs) are well established and that data is loaded as per study timelines (including transfer specifications and reconciliations).

• Ensure data quality by conducting and/or overseeing data management activities including validation, data review, and safety data reconciliation.

• Ensures an efficient implementation and follow-up of DM activities for outsourced trials. 

• Develop and drive the retro planning for important deliverables such as Interim Analysis, DMC, partial, and final database locks.  Ensure clear and prompt updates and escalations to study teams and management.  

• Ensure Database lock readiness by leading the team through the DM lock recommendations and rational, including implementation of Data Point Lock Strategy.

• Drive inspection readiness by ensuring ongoing TMF completion for all DM related documents (including documents coming from third parties if applicable).

About You

Education:
Bachelor’s degree or above, preferably in a life science or health related field or/and 8-10 years of Clinical Data Management in the pharmaceutical industry or equivalent can substitute a formal degree.
Experience:
· 5+ years of experience in Clinical Data Management in the pharmaceutical industry (or equivalent) is required. 2+ years of project management experience in Data Management is required.
· Clinical Data Management System experience (CDMS) and understanding of database/programming concepts.
· Understanding of industry standards, terminologies, (e.g., CDISC SDTM, MedDRA, etc.) current regulatory guidelines, and GCP practices regarding Data Management

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take safe care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention, and wellness programs and at least 14 weeks’ gender-neutral parental leave.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.