Sanofi Group Senior Study Data Manager in Cambridge, Massachusetts
The Senior Study Data Manager is responsible for leading and coordinating the end-to-end quality deliverables of data management activities for clinical trial including study set-up, conduct and close-out, complying with GCP and applicable regulatory guidance. Ensures activities are completed according to agreed standards and timelines. The Senior Study Data Manager is part of the study team; provides comprehensive data management expertise and support to team members; coordinates cross functional teams to ensure the flawless conduct of a clinical trial.
Assuming Lead Data Manager (L-DM) role and autonomously acting as one of study team core member; liaises directly with internal customers (Global Study Manager, Study Medical Manager, Statistician, Risk Based Monitoring, Pharmacovigilance, Quality, etc.) to lead all data management activities for assigned study, discuss timelines and provide study Data management reporting.
Proposes solutions for data management issues that arise during the conduct of a study, and monitor until resolution.
Assuming the planification of all data management activities, considering the overall study timelines and ensure DM activities are conducted as planned.
Leading and coordinating internal DM delivery team (Database Developers, Data Management Programmers and Data Management Specialists) assigned on the study; working as a mentor for new Data Managers and accountable for the quality of data management deliverables.
Accountable for the DM study deliverables, such as CRFs, CRF Completion Instructions, Centralized Monitoring Plan, Data Management Plan, Data Validation Specifications, Data Review Listings/Reports as per company standards and protocol requirements.
Assures that data management standards are followed. Manages study document archiving in eTMF according to eTMF guidance.
Participates in Investigator Meetings and other outside meetings if required. Maintains knowledge of current regulations and technologies related to the data management function.
Defining and implementing the study data cleaning and validation strategy integrating risk based approach.
Involved, as Contributor or Leader, according to the defined processes, in protocol review, Study Risk Management Plan, SAE reconciliation, deviation review, data review, medical review, data surveillance and other review activities during the conduct of study.
Coordinating, in collaboration with vendor external data activities : load, integration activities and reconciliation activities, including External Lab data, eCOA, IRT integration etc.
Participating or leading the implementation of department initiatives. Develops, implements and oversees processes and coordinates activities in conjunction with the internal team and DM TA Leader.
Continually evaluates DM processes and applications for improvements. Participates in working groups to develop and implement new procedures and standards.
Managing service providers (CROs) independently on data management activities and maintains a good working relationship with vendor. Reviews vendor proposal and contract for inclusion of appropriate scope of work, pricing and agreed services.
Performs assessment of vendor performance trends and service risks.
Meets regularly with vendor representative to implement mitigation actions. Obtains appropriate approval for scope of work and budget update.
Reviews and approves vendor invoices based on the contract. Ensures all vendor contract related documents are processed on-time.
Bachelor degree or above, preferably in a life science or mathematics-related area (e.g., computer sciences) and 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.
Knowledge and Skills:
Strong project management skills. Anticipates problems, issues, and delays, and proactively works to minimize the impact. Learns quickly when facing new problems.
Uses rigorous, objective logic and methods to solve difficult problems with effective solutions.
Able to identify risks and propose mitigation plans
Strong leadership behaviors; manages effectively with study team and departmental associates.
Establishes rapport and collaborates inside and outside the company.
Demonstrates flexibility through effective negotiations.
Solid clinical trial development process.
Solid understanding of Data Management scope and objectives
Strong skills to propose and support changes.
Proposes and follow-up new data standards, new data management processes
Understanding of relevant regulatory guidelines, GCP and industry standards and practices regarding data management.
Solid Clinical Data Management System experience (RAVE is highly preferred) and understanding of database/programming concepts.
Expertise in the usage of Data Management applications and database/file structures.
Understands the rationale or is able to identify discrepancies by using query languages, such as SQL.
Able to acquire and apply new technical skills.
Follows through with all tasks and ensures high quality results.
Set clear assignments as well as clear objectives and measures.
Monitor process, progress and results.
Consistently meets deadlines according to accepted levels of quality. Pays attention to details.
Autonomously works as Lead DM role with minimal supervision and be capable of participating in transversal activities.
Good team player.
Vendor management experience and good client facing skills are preferred.
Good interpersonal and communication skills.
Strong English skills (both verbal and written).
Proficiency in Microsoft Office Suite (intermediate level)
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.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.