Senior Study Data Manager

Company: Sanofi
Location: Bridgewater
Posted on: June 25, 2022

Job Description:

JOB SUMMARY: The Study Data Manager (SDM) 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. Ensure activities are completed according to agreed standards and timelines. Serve as the DM representative in the study team. Provide comprehensive data management expertise and support to team members. Coordinate cross functional teams globally to ensure the flawless conduct of a clinical trial.This includes:Being accountable for the quality and timely of data management deliverables for the assigned studies including delivery of accurate and reliable clinical study data to ensure the reliability of the study results.Representing Clinical Data Management in the Core Trial Team (CTT). Liaises directly with internal customers (Global Study Manager, Study Medical Manager, Statistician, Central Monitors, Pharmacovigilance, Quality, etc.) to coordinate all data management activities for assigned studies, discuss timelines, and provide study data management updates. Suggesting solutions for data management issues that arise during the conduct of a study and monitor until resolution.Planning of all data management activities considering the core study milestones and ensuring that DM activities are conducted as planned.Leading DM activities with internal DM delivery team (Database Developers, Data Management Programmers, Central Monitors, etc.) assigned on the study and mentoring new SDMs.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/Visualizations as per company standards and protocol requirements.Assuring that data management standards are followed.Managing study document archiving in eTMF according to eTMF guidance.Participating in Investigator Meetings and other outside meetings if required.When necessary contributing to the delivery of data management activities.Maintaining 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 approaches.Contributing to the protocol review, Study Risk Management Plan, SAE reconciliation, deviation review, data review, medical review, data surveillance and other review activities during the conduct of a study.Coordinating, in collaboration with vendor(s) and internal data integration experts, all external data activities: loading, integration activities and reconciliation activities, including Central Labs, eCOA, IRT, etc.Participating in the implementation of department initiatives. Implements and oversees processes and coordinates activities in conjunction with the internal team and Team Leader. Continually evaluates DM processes and applications for improvements. Participates in working groups to develop and implement new procedures.Ensuring vendor oversight on data management activities at the study level while maintaining a good working relationship with the vendor(s). 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 as necessary. Ensures all vendor contract related documents are processed on-time.KNOWLEDGE, SKILL, FORMAL EDUCATION & EXPERIENCE REQUIREMENTSKnowledge And Skills:Strong data management expertise from study set-up to database lock (i.e., understanding of data management scope and objectives).Strong English skills (both verbal and written).Strong project management skills and experience. Anticipate delivery risks, bottlenecks, issues, and delays to proactively prevent them or minimize their impact.Learn and adapt quickly when facing new problems. Think critically and use rigorous, objective, and pragmatic methods to solve multidimensional problems with effective and timely solutions.Willingness and ability to learn company tools, process and SOPs.Strong collaboration behaviors; manage effectively activities with study team and other DM functions. Establish rapport and collaborates inside and outside the company. Demonstrate flexibility through effective negotiations.Solid knowledge of the clinical trial development process and understanding of relevant and current regulatory guidelines, GCP and industry standards and practices regarding data management.Solid Clinical Data Management System experience (CDMS) and understanding of database/programming concepts. Expertise in the usage of Data Management applications and database/file structures.Follow 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.Good interpersonal and communication skills including negotiation skills.Proficiency in Microsoft Office Suite and electronic data capture systemsFormal Education and Experience Required:Bachelor's 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 Desirable But Not Essential:RAVE is highly preferredVendor management experience and good partner facing skills are preferred.Experience and medical knowledge in relevant therapeutic areaUnderstanding of industry standards and terminologies (e.g., CDISC SDTM, MedDRA, etc.)Knowledge of different data management outsourcing modelsUnderstanding of the impact of eSources on data flows and processesUnderstanding of risk-based methodologies and regulationsExperience in conducting or leading data management activities within Decentralized Clinical TrialsExperience in conducting or leading data management activities for complex protocols such as "Basket", "Umbrella", and "Adaptive"PRINCIPAL DUTIES AND RESPONSIBILITIES MAJOR DUTIES & RESPONSIBILITIES: Lead data management activities on TA level including on time data management deliverables in compliance with GCP's, SOPs and standards.Contribute to the development of cross-functional study plans such as the Study Risk Management Plan.Lead the development of DM specific study plans including the Data Management Plan, the Centralized Monitoring Plan etc. as per timelines defined in SOPs or with the study team.Plan and support as necessary all DM activities to meet the core study milestones (First SIV, FPI, Interim Analysis, DMC, DB Lock, etc.) and monitor their execution considering all internal and external dependencies (Study team contribution, Business Technology, Vendors, etc.). Proactively anticipate, monitor, and remediate issues to ensure continued study team focus on what matters for the delivery of clinical milestones.Lead and cooperate with study team to develop the eCRF, Data Validation Specifications, CRF Completion Instructions, etc. to meet the protocol and statistical analysis requirements while assuring that data management standards are followed at global and TA Level.Ensure Quality by Design of the DM plans and deliverables to minimize change requests after database go-live. Review protocol designs, study vendor capabilities, study risks, etc. to define study specific data management strategies allowing the efficient conduct of the study and to minimize potential issues.Oversee vendor activities (if any) to identify risks and ensure that data management activities are completed according to the SOW, regulations and with expected quality. Implement QC 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 planned (including transfer specifications and reconciliations).Ensure that cross-functional data reviews are executed according to the Centralized Monitoring Plan.Ensure data quality by conducting and/or overseeing data management activities including validation, data review, safety data auto reconciliation, etc.Develop the retro planning and ensure its follow-up for Interim Analysis, DMC, and Final Database lock. Ensure clear and promptly updates on DM activities to study teams and management.Ensure Pre-Lock meeting readiness and lead team through the DM lock recommendations and rational.Drive inspection readiness by ensuring ongoing TMF completion for all DM related documents (including documents coming from third parties if applicable).Ensure CDM documentation and eTMF filing for inspection readinessCommunicationEnsure clear, concise, consistent, and timely communication on data management activities at study level (including risks identification, monitoring, alert, and escalation).At study level, takes ownership to hold data management related meetings (e.g., eCRF interactive Review Meetings, Data Review Meetings, Pre-lock Meetings, etc.) and ensures follow-up actions are clearly defined and implemented.At study level, actively participates in meetings as applicable (e.g., investigator meeting, Study Team meetings, etc.).Coordinate with study team and other internal and external stakeholders (e.g., third parties, Trial Operations, Business Technologies, etc.) to ensure that DM activities are delivered as planned.Support other functional teams requiring data management expertise.Mentor new team members & Resource management on study levelAct as mentor for Data Management supports; responsible for the data quality delivered by team member at study level.Mentor and coach new Clinical Data Managers on all operational aspects needed for the successful completion of a trial.Innovation and continuous quality /process improvementIdentify opportunities and suggest solutions to streamline tools, processes and increase data quality.Provide inputs and alternatives solutions to new approaches and initiatives within data management, keeping all cross-functional stakeholders in mind.Ensure process consistency by implementing global SOPs, policies, guidelines, standards, or related tools updates at study level.At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce - and workplace - which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.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.As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.GD-SALI-SAAt 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.PDN-966f25ed-413e-483a-bcaa-1ef84bc5def7

Keywords: Sanofi, Trenton , Senior Study Data Manager, Executive , Bridgewater, New Jersey