Clinical Lead H/F
il y a 1 semaine
Clinical Data Management Study Lead F/M
Ipsen Innovation (SAS)
The Clinical Data Management (CDM) Study Lead defines, implements and monitors the Data Management strategy for one or more clinical studies in Ipsen portfolio. 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 is the Data Management subject matter expert (SME) and consequently is accountable for the Data Management deliverables of his/her projects. He/She ensures that the clinical data collected, processed and reported are supported according to high quality, rigorous, objective and informative Data Management procedures and processes.
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 acts as the reference in terms of Data Management specifics related to the DM related 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). 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
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. 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. 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).
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.
Participate in the continuous improvement of the Data Management system in Ipsen.
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
Participate at the EHS training, proposed in the framework of the training at post of work.
Inform his / her superiors of any changes affecting the post of work, so that the single document evaluation of occupational risks, can be updated, as well as any useful information to better take into account the EHS on site
Ideal: More than 5 years of experience in Clinical Data Management
Minimum: 4 years as Clinical Data Manager with proven project management capabilities in a pharmaceutical company or in a CRO and at least one project on a neurological disease
Good budget management understanding
Excellent organizational and project management skills
Ideal: advanced degree in life sciences and/or Information Technology applied to life sciences
Minimum: a minimum of a graduate degree
Language : fluent in English; French would be an advantage
Advanced knowledge of clinical studies' Data Management
High knowledge of international standards (ICH, GCP, CDISC ...) and regulations related to clinical studies, electronic data capture and data management
High level of expertise in the use of the data-management software including for example Medidata RAVE
Good level of expertise of oversight and management of external vendors
Excellent IT and Microsoft Office skills
independent problem solving and self-direction.
LI-Remote
#Dans le cadre de ses recrutements IPSEN s'engage au respect de l'égalité de traitement des candidats, indépendamment du sexe, de l'âge, de l'orientation sexuelle, de l'origine ethnique, de la couleur de la peau, de la nationalité, du handicap ou de l'appartenance à un syndicat.
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