Clinical Data Management Team Lead

Main duties and responsibilities

• Support implementation of Data Management departmental plans and objectives established by the Head of Data Science.
• Identify and implement agreed improvements to operational efficiency, processes and working practices.
• Monitor team capacity, resource allocation and staff utilisation, highlighting operational pressures and providing input to workforce planning.
• Provide operational input to study quotations, resource estimates and bid discussions when requested.

• Provide direct line management and day-to-day leadership to assigned Data Management personnel.
• Conduct regular one-to-one meetings, probation reviews, appraisals and performance discussions; provide timely feedback and support.
• Manage routine leave, absence, attendance and staffing matters in accordance with company policies and delegated authority.
• Coordinate team workloads and study assignments, balancing priorities, available capacity and delivery timelines.
• Monitor individual and team KPIs, address routine performance concerns and escalate significant or unresolved matters.
• Support recruitment, onboarding, succession planning and a collaborative, accountable team culture.

• Ensure day-to-day Data Management activities follow applicable SOPs, working instructions, Good Clinical Practice (GCP) and relevant regulatory and industry requirements.
• Identify, address and escalate procedural or compliance gaps, and support implementation of changes to regulatory or quality requirements.

• Oversee the day-to-day delivery of Data Management activities across the clinical study portfolio, ensuring work is progressing in accordance with agreed timelines, quality standards and study requirements.
• Maintain a comprehensive understanding of the status of all active studies, including key deliverables, upcoming milestones, outstanding activities, risks and resource requirements.
• Provide operational oversight and review of Data Management activities throughout the study lifecycle, including study start-up, Data Handling Plans, eCRF development and validation, data cleaning, medical coding, external data reconciliation, database lock, data export and archival.
• Regularly review study progress and deliverables with the assigned Data Managers, ensuring activities are appropriately planned, prioritised and completed to the required standard.
• Identify potential delays, quality concerns, resource constraints and other operational risks, working with the team to resolve issues proactively and escalating significant matters to the Head of Data Management where necessary.
• Provide technical guidance, review and support to Data Management personnel, ensuring consistent application of departmental procedures and good Data Management practices.
• Ensure effective coordination of Data Management activities across the portfolio, balancing competing priorities and supporting the timely delivery of study milestones.
• Promote accountability within the team, ensuring individual Data Managers retain responsibility for the execution and delivery of their assigned study activities.

• Coordinate and monitor risk-based data quality control activities to support accuracy, completeness and consistency of clinical trial data.
• Review quality metrics, recurring discrepancies and process weaknesses, and coordinate agreed corrective improvements.
• Support audits, inspections, incident investigations and CAPA implementation as required, escalating significant quality matters.

• Support implementation and effective operational use of Data Management systems, ensuring appropriate team training and process adoption.
• Identify system limitations and opportunities for automation or improvement, and work with IT and vendors to resolve routine operational issues.

• Work closely with Clinical Operations, Biostatistics, Quality Assurance, IT and other functions to coordinate study activities and effective data flow.
• Represent Data Management in operational meetings and resolve routine cross-functional issues, escalating significant concerns.

• Coordinate routine interactions with external Data Management vendors and third-party service providers.
• Monitor operational deliverables, timelines and vendor performance, supporting issue resolution and assessments as required.

• Identify staff training and competency needs through supervision, appraisals and competency reviews.
• Coordinate onboarding, mentoring, role-specific training and ongoing professional development; monitor completion and address gaps.
• Promote consistent working practices, knowledge sharing and continuous learning.

Qualifications and Experience

• Previous relevant clinical Data Management experience within NHS, Academic, pharmaceutical, biotechnology or CRO industry.
• Experience coordinating Data Management activities at portfolio level and managing timelines and deliverables.
• Strong understanding of EDC systems and clinical Data Management processes, including eCRF development, data cleaning, reconciliation and database lock, with experience supporting both site-level and sponsor-facing Data Management activities.
• Good working knowledge of GCP, E6R3 and relevant clinical trial regulatory and industry requirements.
• Demonstrated ability to lead, supervise or mentor colleagues and support their performance and development.
• Strong organisational, analytical, problem-solving and communication skills.
• Ability to work effectively with cross-functional teams and external providers.
• High ethical standards and integrity in handling confidential clinical trial data.
• Previous formal line management experience, including appraisals, performance management and recruitment.