Director of Clinical Data Management Operations

Job Title: Director Operations
- Clinical Data-Management (CDM)

Division / Function: Data Management, Standards & Systems / Clinical Development Operations

Location: Paris (FR), London (UK), or Boston (US)

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.

• Define, implement, and oversee Quality Management (QM) within CDM. This includes, but is not limited to:
  Creating and implementing a QM framework in CDM that defines quality goals, processes and KQIs;
  Working collaboratively with Quality Assurance (QA) so that the QM framework works harmoniously and efficiently with QA processes and procedures;
  Working with QA and CDM Operations to ensure quality findings, CAPAs, audit or inspection reports or findings, or other quality-related actions are completed on time;
  Ensuring CDM-related documents are appropriately filed in the Trial Master File (TMF) by collaborating with QA, Ipsen CDM, and external partners.
• Works collaboratively with Asset Data Management leaders, Talent Acquisition (TA), and external vendors and partners to identify and secure personnel resources. This includes, but is not limited to:
  Creating and managing a resourcing requirement model or tool that evaluates needs on an ongoing basis;
  Establishing a process to secure the right people at the right time and communicating status of the resourcing requests to stakeholders;
  Devising a mechanism to manage peaks and troughs in resourcing needs to ensure deliverables are met.
• Manages the CDM documentation environment such as Standard Operating Procedures (SOPs) and other working guidelines, procedures and processes. This includes, but is not limited to:
  Ensuring the correct SOPs, etc., are in place to meet regulatory requirements while providing guidance to CDM staff and partners on how to conduct Ipsen CDM trials;
  Periodic review and revision of CDM documentation;
  Distribution, training, and oversight of training compliance with SOPs, etc., as they are developed or revised;
  Creating, implementing and overseeing a model to evaluate SOP compliance by CDM staff through methods such as review of training records, periodic assessments or audits, and trial-specific / team-specific / vendor-specific “spot checks.”
• Direct change management activities within CDM. This includes, but is not limited to:
  Establishing a change management methodology to be used within CDM including strategy, framework, project management of initiatives, measurement of status and success, and communications;
  Promoting and advocating a change management mindset across CDM;
  Developing and leading change management initiatives and projects as defined by the CDM leadership team, whether they are driven by cultural, process, technical or other origin;
  Working collaboratively and effectively with broader change management leaders at Ipsen;
  Participating in and aligning with broader Ipsen change management initiatives as necessary;
  Collaborating with partners to leverage their expertise and support with Ipsen CDM change management initiatives.
• Participate in operational governance with external partners. This includes, but is not limited to:
  Working directly with partners on initiatives such as change management, resourcing, process changes; innovation, KPIs/KQIs/metrics, etc., as assigned;
  Participating in operational governance meetings and executive governance meetings as requested.
• Track, manage, and report on CDM KPIs, KQIs, and other metrics. This includes, but is…