Senior Director, Clinical Data Management

Technical skills

• Extensive experience managing and governing clinical information standards and related activities, including the development and implementation of clinical data standards.

• Deep knowledge of and experience with applying industry standards (e.g., Controlled Terminologies, CDISC [Clinical Data Interchange Standards Consortium], CDASH [Clinical Data Acquisition Standards Harmonization], SDTM [Study Data Tabulation Model], ADaM [Analysis Data Model], & HL7 [Health Level Seven International]) and requirements for analysis & reporting and submission deliverables (e.g., SDRG [Study Data Reviewer’s Guide], ADRG [Analysis Data Reviewer’s Guide], Define.xml)

• Deep understanding of and experience with clinical development trial processes, including data management and worldwide regulatory DM (Data Management) & reporting requirements.

• Demonstrate understanding of program-level clinical and business requirements and impact of standards.

• Strong knowledge of the Drug Discovery Process, ICH (International Council for Harmonization) and GCP (Good Clinical Practice) guidelines.

• Demonstrate advanced knowledge across multiple (>2) therapeutic areas with ability to drive consistency across all studies in clinical development programs and / or therapeutic areas.

• Knowledge of Analysis & Reporting.

• Electronic Data Capture and external supplier data expertise.

• Ability to take an enterprise-wide view of study needs that is inclusive of Controlled Terminology, SDTM, analysis and reporting, and submission targets and deliverables to ensure appropriate application of standards.

• Ability to interpret the study protocol as it relates to study design. Ability to interpret protocol requirements to facilitate cross-functional understanding of data types and sources which are then translated into high quality, compliant data standard definitions.

Non-technical knowledge, skills, and abilities

• Exceptional communication and collaboration across cross-functional and global teams; tailors messaging up, across, and down; crafts decision-ready narratives and frames options, risks, and recommendations for senior leaders and direct reports.

• Strategic leadership, with the ability to align diverse teams and stakeholders around shared objectives and long-term direction.

• Influential people leadership, leading through influence to motivate cross-functional and geographically diverse teams, build capability and consistency, and foster an inclusive, high-trust culture.

• Sound judgment and decision-making, operating effectively in ambiguity, managing escalations, and driving cross-functional consensus on process and technology improvements (including RCA [Root Cause Analysis]/ CAPA [Corrective and Preventive Action] where applicable).

• Inclusive leadership and talent stewardship, fostering psychological safety and communities of practice, and recruiting, developing, and retaining top talent across regions and sourcing models (FTE/contingent/on- and off-shore).

• Advanced stakeholder management and negotiation skills across functions, geographies, and seniority levels.

• Ability to lead change, embed innovation, and drive continuous improvement and operational excellence, including adoption of standardized ways of working and measurement of uptake.

• Continuous improvement and operational excellence mindset, proactively identifying and advancing enhancements to ways of working, tools, and governance.

• Ability to recruit and retain talent and plan resourcing across regions and sourcing models (FTE [Full Time Equivalent]/contingent/on- and off-shore).

Qualifications & Experience

• Bachelor’s Degree and minimum of 13 years' experience in Clinical Data Management (or related discipline), including;

• 3 years needs to be in clinical data standards development or metadata management

• Minimum of 5 years people management experience (direct or matrix)

• Demonstrated deep subject matter expertise

Travel Requirements

Preferrednice to have

• Member of the Association of Clinical Research Professionals Certified Professional (ACRP – CP)

• Experience managing clinical data management processes including eCRF (electronic Case Report Form) design, clinical database development and validation, user acceptance testing, external data management, data extraction, data transformation to SDTM, and analysis & reporting

• PMP (Project Management Professional) certification and/or experience in project management

• Knowledge of clinical data metadata & information management principles and practices, new technologies and regulatory requirements for submission deliverables

• Knowledge of FAIR (Findable, Accessible, Interoperable, Reusable) and ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate) principles and their application to information management and stewardship

• Ability to leverage technical solutions to manage functional and/or project deliverables and associated quality

• Ability to use programming and other applications to generate insights from data

Preferred Skillsnice to have

Enterprise Leadership Skills

• Strategic Planning | Define information strategies. Define new approaches that leverage standards and technologies to optimize business processes. Define strategies for the adoption of industry regulations and standards and for developing new standards (e.g., new TAs) and tools. These require cross-functional engagement & alignment, plans for development and implementation, and communication and change management for successful adoption.

• Networking and Partnerships | Involve others—Ask others for their opinions and ideas to gain their support when clarifying the situation, developing solutions, exploring needed resources and committing to action

• Innovation | Challenge current thinking—Explore alternative ways to view and solve problems and achieve results; leverage innovation tools, creative processes and varied cross-functional experts to generate ideas; combine ideas in unique ways; make times to incubate ideas; thoughtfully evaluate alternatives and then select the best ideas for experimentation.

People Management Responsibilities

• Set clear objectives aligned to organizational goals; assign work and set priorities.

• Conduct regular check-ins and annual reviews; coach for performance; provide recognition.

• Develop career plans; create growth opportunities and promotion cases; ensure appropriate training and mentoring.

• Lead recruiting and hiring; manage sensitive employee-relations matters in partnership with HR.

• Balance workloads to support value-added work and work–life sustainability; anticipate obstacles and adjust plans.

• Coordinate on-shore/off-shore and contingent resources; ensure role clarity and effective handoffs.

• Manage an operating budget and optimize spend against priorities.

• Align teams around a clear direction; facilitate team/functional meetings.

• Provide concise, decision-ready updates and status reporting to leadership and partners

• Medical, dental and vision insurance

• Retirement benefits including 401(k)

• Paid holidays

• Vacation

• Sick and compassionate days

• Annual bonus and long-term incentive eligibility

Hazardous Material(s)