Clinical Data Group Leader

**WHAT -**Summary & Purpose of the Position**
- As an expert and accountable within their allocated Therapeutic Area/Assets, represent GM Data Management strategically in planning/execution of all global and local evidence generation activities of Ipsen group and provide oversight of the excellence in clinical/RW data collection/management and delivery process;
- Scope of projects is from phase II to late phase studies and Real World Evidence generation projects including:

- Any kind of prospective / cross sectional studies/registries as well asRetrospective chart reviews
- To provide oversight on execution of clinical/Real World databases presentation to the analysis and reporting process for clinical trials/registries/evidence generation projects, and in such a way that the evaluation of such data will withstand interrogation and examination by the various Regulatory bodies
- To elaborate strategies for the implementation of data management state of the art processes and for the enhancement of productivity
- To supervise the contractors dedicated to support the projects and be ultimately accountable of the deliverables

**WHAT - Main Responsibilities & Technical Competencies**
- To provide data management oversight and leadership with Medical Key Opinion Leaders / Medical Directors / Clinical Research Managers /TA clinical operations Directors / Project owners and other data management support/statistics colleagues and Service Providers assigned data processing projects,
- To review, and input into operational feasibility to ensure execution, timelines and budget assessments are appropriate to meet study/program Data Management objectives (from high level feasibility and continual review thereafter)
- To complete all the above activities within the framework and in compliance with GCP/ GPP Ipsen SOPs and other documentation/guidances in force within/outside the Ipsen Group
- To be a referent & key contact point and representative for all GM DM related activities for Therapy Area vis-à-vis TA Medical Directors, TA Clinops Directors, Head of Regional Clinical Operations, Procurement, GPS, QA, cross-functional taskforces.
- To ensure that, in conjunction with Biometrics Director, all projects have a high quality, timely and robust data management strategy. This includes ensuring:

- To participate in selection, management, operational governance of study Service Providers in area of responsibility.
- That clinical study protocols are developed with data management input as early as possible, and that data management review and approval of other relevant study documents (e.g. CRF, Data Management plan), led to high quality, robust, rigorous objective standards
- That robust data flows are defined and implemented (i.e. robust and quality integration and reconciliation of data managed by central laboratory, ECG central readers, electronic patient diaries providers, Electronic Health Records etc )
- That DM activities are properly scheduled and tracked
- To be responsible for increasing the awareness of clinical research staff in all local/regional levels, of the importance of maintaining optimal methods and processes of data management for clinical trials/registries/Evidence Generation projects
- To develop and improve data management processes in coordination with the Biometry Director, and other appropriate colleagues to achieve greater productivity and a standardized integrated approach
- To be responsible for the recruitment / training / supervision of the contractors dedicated to support the projects

**HOW - Knowledge & Experience**

Knowledge & Experience (essential):

- Life science graduate or other relevant qualifications
- Approximately 10 years’ experience in clinical data management (including late phase),
- Knowledge of GCP / GPP and ICH guidelines relevant to data management,
- Substantial experience of commissioning and managing out-sourced data management contracts, preferably with clinical research organizations
- Able to work in a multidisciplinary team, in an international environment, seeking and valuing the contribution of others
- Capable of demonstrating the capacity to plan effectively and interact satisfactorily with staff of differing disciplines and at all levels of seniority
- Multiple EDC systems expertise
- Knowledge of the CDISC Model
- Fluent in English

Knowledge & Experience (preferred):

- Life science graduate or other relevant qualifications
- Approximately 10 years’ experience in clinical data management / in Electronic Data Capture in both development and post authorization areas,
- Thorough knowledge of GCP / GPP /GCDMP and ICH guidelines relevant to data management,
- Substantial experience of commissioning and managing out-sourced data management contracts, preferably with clinical research organizations
- Able to work in a multidisciplinary team, in an international environment, seeking and valuing the contribution of others
- Capable of demonstrating the capacity to