Data Management Team Leader
Posted on: November 25, 2022
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
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
- Effective leadership and people management skills. Harness a
working environment which encourages teamwork, energy, and
- Ability to efficiently implement management vision and
- 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
- 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
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
- 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
- Support the SDMs to develop and execute operational plans to
successfully deliver studies on time, within budget and meeting
- 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
- Ensures process consistencies in the operational development
- Identify synergies to optimize DM project/study team
- Support the development of Global, TA and Compound specific
standards, KPI/QPIs, etc meeting global and regional
- 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
- 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
- Coach individuals on the deep understanding of the day to day
- 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
- 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
- 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,
- Define clear assignments for each individual DM in her/his
sub-group (incl., managing CDM project assignment tools and
- 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
- 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
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
- 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
- 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
- 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
- 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
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