Clinical Data Management Study Lead

Title:

Clinical Data Management Study Lead

Company:

Ipsen Bioscience, Inc.

Job Description:

Clinical Data Management Study Lead

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. The Study Lead is responsible for delivering high-quality databases by external vendors in adherence to Ipsen standards, meeting project timelines and budgets. 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.

The CDM Study Lead represents the CDM function in the clinical study team(s); discuss and explain the DM needs and constraints within these teams and informs the CDM program Lead on advances and issues for the projects.

The CDM Study Lead is the Data Management subject matter expert (SME) and consequently is accountable for the Data Management deliverables of assigned projects. The Study Lead ensures that the clinical data collected, processed, and reported are supported according to high quality, rigorous, objective, and informative Data Management procedures and processes.

The CDM Study Lead 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.

The CDM Study Lead participates in the Service Provider selection (from Scope of Work to contract, including Bid defense), oversees external vendors for outsourced activities and is responsible for the corresponding deliverables (quality, budget, and timelines). The Study lead will follow metrics and KPIs, implement corrective actions and escalate to the DM Program Lead when necessary.

The CDM Study Lead acts as the key contact in terms of Data Management specifics related to the relevant DM activities.

Main Responsibilities/Job Expectations:

Responsibilities include, but are not limited to the following:

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 with 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, centers…) 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. Follows metrics and KPIs, implements corrective actions in conjunction 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 & 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 intelligen