Clinical Data Management Study Lead F/m

**Summary / purpose of the position**

The Clinical Data Management (CDM) Study Lead defines, implements and monitors the Data Management strategy for one or more clinical studies in Ipsen portfolio. He/She is responsible for delivering of high-quality databases by external vendors in adherence to Ipsen standards, meeting project timelines and budget. This includes monitoring the quality, anticipating and mitigating the risks as part of the risk management plan and measuring the performance through metrics and KPI.

He/She represents the CDM function in the clinical study team(s), discuss and explain the DM needs and constraints within these Teams and inform the CDM program Lead on advances and issues for the projects.

He/She ensures that clinical databases in the project(s) are consistent with Ipsen data standards and presented to the analysis and reporting process in such a way the evaluation of data will withstand interrogation and examination by regulatory bodies.

He/She participates to the Service Provider selection (from Scope Of Work to contract including Bid defence) oversees external vendors for outsourced activities and is responsible for the corresponding deliverables (quality, budget and timelines). He/She follows metrics and KPIs, implements corrective actions and escalate to the DM Program Lead when necessary.

He/She acts as the reference in terms of Data Management specifics related to the DM related activities.

**Main responsibilities / job expectations**

**Related to study activities**:

- Organize and coordinate the Data Management activities from clinical synopsis / protocol review to the clinical study report and up to clinical data submission when applicable, in accordance to program level specificities
- Define and put in place a high quality, timely and robust data management strategy for the project (e.g. data capture tool, management of external data, data flow for submissions). Develop and implement project specific guidelines and support documentation
- Ensure that the Data Management activities related to collection, processing and data transfers to the Ipsen data warehouse are conducted in compliance with procedures and best practices
- Participate to selection of external vendors by evaluating their ability to deliver in the context of Ipsen projects.
- Oversee the external vendor’s activities and deliverables and report on the status of Data Management tasks as needed to the Study Team / Submission Team. Make sure that subcontracted activities are delivered in line with the project expectations (timelines, quality and budget). Follows budget and potential change orders in relation with the Clinical Development Programs Department.
- Ensure compliance of the data management deliverables with Ipsen rules and standards (e.g. standard database within Ipsen data warehouse) and ensure that the requirements from the clinical study protocol and the statistical analysis are fulfilled.
- Monitor the data quality, completeness and trend between subgroups (e.g. between countries, centres ) at different pre-identified and agreed time point in a project corresponding to milestone such as data review, DMC, interim analysis using tools such as those developed for risk based monitoring. He/She follows metrics and KPIs, implements corrective actions in conjonction with Study Team / Project Team and escalate to the DM Program Lead when necessary.
- Coordinate all necessary activities to reach in a timely manner the database lock milestone such as making sure that the last transfer is complete (included all external data, randomization data, coding, SAE reconciliation is complete).

**Processes and recommendations**
- As an expert of the therapeutic area field, support the standard team in setting up therapeutic area specific standards, advice study teams in terms of best practices on data collection and usages, supervise CROs if needed.
- Participate to the implementation of data quality systems and procedures and identify any needs for improvement.
- Perform new technologies intelligence and adapt to them as appropriate. Participate in the continuous improvement of the Data Management system in Ipsen.

**Specifics of Position**
- Ability to manage data management 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 partners
- Ability to produce high quality, accurate work to meet deadlines
- Ability to satisfactorily interact with staff from differing disciplines
- Responsible, flexible and accountable with a pro-active approach
- Ability to perform technical tasks and good understanding of clinical database structures and models
- Understand the basic needs of statistics and programming
- Understand the basics of the disease therapeutic area

**EHS Mission / Duties to be performed on the site of Les Ulis**
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