Director of Clinical Data Management Operations London

The Director Operations - Clinical Data-Management is responsible for the management of critical, trial and non-trial specific activities and functions that support the Clinical Data Management organization. He/She is responsible for leading the development of and oversight of administrative and trial and non-trial operations to help ensure Ipsen and Ipsen CDM meet or exceed Ipsen goals and objectives, maintain regulatory compliance, and effectively work with strategic partners. He/She is an integral part of the CDM leadership team helping define and execute near and longer term strategies in collaboration with CDM and Ipsen leadership.

Main Responsibilities & Technical Competencies

• Define, implement, and oversee Quality Management (QM) within CDM.
• Work collaboratively with Quality Assurance (QA) so that the QM framework works harmoniously and efficiently with QA processes and procedures.
• Ensure quality findings, CAPAs, audit or inspection reports or findings, or other quality-related actions are completed on time.
• Manage the CDM documentation environment such as Standard Operating Procedures (SOPs) and other working guidelines, procedures and processes.
• Direct change management activities within CDM.
• Participate in operational governance with external partners.
• Track, manage, and report on CDM KPIs, KQIs, and other metrics.
• Contribute to innovation initiatives as requested.
• Manage Ipsen CDM training environment.
• Other administrative, operational assignments as requested.

Trial / Study-related responsibilities

• Direct management of Ipsen CDM resources that are “pooled” across therapeutic areas including coding and data cleaning when that work is done “in-house” by Ipsen CDM.
• Ensure study timelines and deliverables are met by team members with quality.
• Work collaboratively with Ipsen CDM leadership to ensure appropriate resourcing, study expectations, deliverables, and timelines are understood and achieved.

Leadership / Management

• Responsible for the recruitment, talent development, line management and supervision of team members in his/her team including objectives definition, appraisal review, and performance management.
• Responsible for building capabilities and technical skills within his/her group to ensure effective, high-quality delivery.
• Member of the Ipsen CDM Leadership team, successfully participating and executing responsibilities as assigned by the Ipsen Head of DMSS.

Behavioural Competencies Required

• Purpose Dedication: Safeguards data integrity and patient safety.
• Thinking Dexterity: Connects study execution to asset and submission strategy.
• Social Agility: Collaborates effectively across Clinical Operations, Biostatistics, Programming, Regulatory, and external partners.
• Growing Self and Others: Leads, coaches, and develops Data Management staff.
• Being Intentional: Operates effectively in ambiguity and changing development environments.
• Making Real Impact: Delivers reliable, inspection-ready databases on time and within budget.

Knowledge & Experience

• Ability to manage large projects: plan activities and tasks, identify project constraints and dependencies, identify and mitigate risks, report on project status, produce progress metrics, and communicate efficiently with external vendors as well as internal stakeholders.
• Approximately 5-7 years of experience in a CDM leadership position with proven Project Management skills in Data Management activities at a development program level.

Education / Certifications (essential)

• Life Science and/or Information Technology graduate.

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