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Data Management Team Leader

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

Job Description:

JOB SUMMARY:
The Data Management Team Leader (DMTL) is leading a regionally based CDM team ensuring that the data management activities assigned to his/her team are completed according to agreed standards at global, TA and Product Level, timelines, and quality/performance targets.Acting as DM Team Lead includes:

  • Managing a team of Study Data Managers (SDMs), including performance review and development dialogue.
  • Acting as the Data Management point of accountability for the execution of data management activities for specific clinical studies / programs assigned to his/her team.
  • Ensuring the training, mentoring, engagement, development, and recognition of his/her team members to maximizing their potential, performance, and overall success.
  • Assisting the CDM Regional Head with resource optimization based on the portfolio risk adjustments, team member competencies, and core project milestones.
  • Driving and supporting his/her team planning and delivering strong study execution operational plans based on best data management practices and robust risk management strategies.
  • Ensuring operational consistency, alignment and identifying synergies across assigned studies and programs.
  • Defining and implementing vendor oversight strategies tailored for the insourcing/outsourcing scope and model.
  • Participating in global harmonization and optimization of operational processes and standards and fosters innovation and continuous improvement.
    KNOWLEDGE, SKILL, FORMAL EDUCATION & EXPERIENCE REQUIREMENTSKnowledge and Skills:
    • Strong data management expertise (i.e., understanding of data management scope and objectives).
    • Strong project management skills and experience. Anticipate delivery risks, bottlenecks, issues, and delays to proactively prevent them or minimize their impact across multiple studies and programs.
    • Effective leadership and people management skills. Harness a working environment which encourages teamwork, energy, and creativity.
    • Ability to efficiently implement management vision and decisions.
    • Ability to rally a team behind the management vision and/or decisions to maintain a high level of engagement.
    • Strong interpersonal, negotiation and communication skills (verbal and written) with a customer focus mentality (incl. Ability to appropriately and constructively escalate)Strong organizational skills, flexibility, efficiency in matrix organization, strong ability to effectively handle large and complicated global drug development projects and/or initiatives.
    • Business Acumen skills: Willingness to promptly and efficiently deal with a "business situation" (risks and opportunities) in a manner that is likely leading to a positive outcome.
    • Experienced in successful vendor management and oversight.
    • Ability to analyze complex protocol designs, processes, vendor capabilities, data flows and data trends to design data management strategies allowing the efficient monitoring of activities to prevent and/or detect issues.
    • Ability to effectively serve as a change management agent.
    • Solid level of understanding of clinical data management systems, database and programming concepts, database structures, and file structures.
    • Knowledge of industry standard tools, processes, and SOPs.
    • Strong knowledge in clinical trial development process.
    • Understanding of relevant and current regulatory guidelines, GCP and industry standards and practices directly or indirectly impacting data management.
    • Knowledge of local Human Resource regulations and policies.
    • Strong English skills (verbal and written) i.e., ability to exchange fluently (incl. negotiation).
    • Strong knowledge of Microsoft Office
      Formal Education and Experience Required:
      • Bachelor's degree (or equivalent) or higher in relevant scientific and/or medical field and a minimum of 8 years' experience in clinical research in pharmaceutical/CRO industry. Successful experience in Clinical Data management of complex studies/programs.
        Knowledge and Skills Desirable but Not Essential:
        • Experience in RAVE or Inform
        • Experience in relevant therapeutic area(s)
        • Prior managerial experience preferred
        • Understanding of industry standards and terminologies (e.g., CDISC SDTM, MedDRA, etc.) preferred
        • Understanding of risk-based methodologies and regulations preferred
        • Understanding of the following advanced drug development concepts is desired:
          • eSources on data flows and processes
          • Decentralized Clinical Trials
          • Complex protocols such as "Basket", "Umbrella", and "Adaptive"MAJOR DUTIES & RESPONSIBILITIES:Lead team Study Data Managers (SDM) and support his/her team as the single DM point of accountability for the operational delivery of clinical studies (timelines, budget, and quality)
            • Understand the business strategy and objectives for clinical programs managed by his/her sub-group. This includes understanding and planning how different studies fit together (e.g. how the readout from a study informs the next steps and overall program strategy).
            • Support the SDMs to develop and execute operational plans to successfully deliver studies on time, within budget and meeting quality targets.
            • Ensure robust vendor oversight plans across assigned studies tailored for the insourcing/outsourcing scope and model. Monitor adherence to the plan.
            • Contribute to partnership level meetings as needed to further secure harmonization, vendor deliverables.
            • Provide Project Management expertise to support SDMs in critical path management, risk identifications, mitigation plan definition and implementation.
            • Maintain day-to-day oversight of his/her data management team execution and performance to meet agreed upon deliverables.
            • Proactively anticipate, monitor, and remediate issues to ensure continued study team focus on what matters for the delivery of clinical milestones.
            • Ensures process consistencies in the operational development and execution.
            • Identify synergies to optimize DM project/study team organization.
            • Support the development of Global, TA and Compound specific standards, KPI/QPIs, etc meeting global and regional requirements.
            • Support pro-active readiness strategies for audits and inspections by ensuring ongoing TMF completeness and quality of DM Documentation. Support the preparation of inspection story boards. Lead study CAPA as necessary.Manage and develop people
              • Work with HR on recruitment, talent retention and staff development.
              • Ensure performance and development cycle is completed for all member of his/her team: set clear goals, identify development areas, and provide regular constructive feedbacks. Support his/her sub-group to develop Individual Development plan.
              • Ensure adequate resourcing to perform study data management activities.
              • Coach individuals on the deep understanding of the day to day operational activities.
              • Identify opportunities for people to "right fit" for business and personal success, leveraging Headcounts towards priority projects to drive operational success.
              • Share the strategic vision of the organization to his/her team, being open and aware to his/her environment.
              • Handle administrative activities (e.g. labor time, travel, and expenses review and approval; use of required Management reporting tools/systems, etc.) in accordance with corporate and departmental guidelines/policies.Ensures Clear, Concise, Consistent and Timeline Communication
                • At project level, actively participate in meetings as relevant (e.g. Division / Unit level meetings, TO, CSO Project Teams meetings, Safety Monitoring Team meetings, etc.)
                • Ensure communication and alignment with CDM Head, DM TALs and other functional Head.
                • Interact with counterparts in other CSO functions and Business Unites to contributes to actions that can limit the silos within Trial Operations and its stakeholders.Assists CDM Head in resource management.
                  • Provide feedback to CDM Regional Head regarding individual resourcing considerations for skill-set and study team alignment considerations and in collaboration with other DM TLs regarding resourcing needs vs actual workload, risk assessment, timelines, and budget.
                  • Define clear assignments for each individual DM in her/his sub-group (incl., managing CDM project assignment tools and WPA)
                  • Identify opportunities for resources optimization.Promote global harmonization, simplification, and optimization of operational processes and standards and fosters innovation and continuous quality /process improvement
                    • Fosters a productive team environment aligned with CSO-TO Mission and Objectives.
                    • Identify opportunities and suggest solutions to streamline processes and increase data quality.
                    • In collaboration with other functions and TA experts, act as a change agent, driving change and implementation of new approaches and standards within his/her sub-group, with a high level of team spirit and motivation.
                    • Ensures consistent, timely and appropriate circulation of updated information.
                    • Participates in the development of global SOPs, policies, guidelines, or related tools via participation in working groups and collaboration with Transversal Services.
                    • Identify and communicate lessons learned, ensure cross-fertilization and knowledge sharing to all clinical operational teams.
                      COMPLEXITY & PROBLEM SOLVINGMajor Challenges/Problems:
                      • Lead a CDM team able to develop strong operational plans / strategy to deliver studies on time, with high quality and reliable data and within budget. Drive a culture of operational accountability / ownership.
                      • Facing problems and complexities resulting from protocol designs, data streams, maturity of study technologies and vendors, supporting CDM Head to leverage DM resources to handle challenges proactively.
                      • Facing requests from multiple internal and external stakeholders, communicates smoothly to manage the requests and streamline the strategy through a cost-effective and positive approach, maintaining data management deliverables and sustaining quality.
                      • Ensures alignment across product/indication, deliver smooth and accurate and timely communication within TO and other department leaders including customers.
                      • Managing Change Management through an effective and positive approach, maintaining operational deliverables and sustaining people motivation and development.Key Internal and External Relationships.
                        • CDM Head, TO TA Head, DM TALs, TO transversal experts, CSO departments, Pharmacovigilance, Regulatory, Finance, Legal, HR, Clinical Procurement, CRO, other clinical trial vendors (e.g. IVRS, Central Labs), Medical Affairs, Strategic divisions.
                          ACCOUNTABILITYDecision Making Authority:
                          • All decision-making linked to management of people e.g., training, coaching and collaborator development, implementation of processes, allocation of resources. Shares accountability for the worldwide execution of clinical programs conducted in his/her sub-group in agreement with the global defined strategy, expected timelines, regulatory and quality requirements, and allocated budgets.
                            • Resolves operational issues that could affect product(s) timelines or quality in conjunction with the GSM(s), DM TAL(s), and other project team members. Proposes options to the project team(s) that maximizes the value of the project(s) while considering other functions constraints.
                              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.According to the CDC, an individual is considered to be "fully vaccinated" fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.#GD-SA
                              #LI-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.

Keywords: Sanofi, Trenton , Data Management Team Leader, Accounting, Auditing , Bridgewater, New Jersey

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