Clinical Data Management Study Lead F/M
il y a 1 semaine
Clinical Data Management Study Lead F/M Company:
Ipsen Innovation (SAS) Job Description: 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 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 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).
- 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.
- 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
- Within its sphere of activity, to respect the regulation, to apply the IPSEN good practices and standards, and the EHS procedures set up on the site.
- Participate at the EHS training, proposed in the framework of the training at post of work.
- Contribute to reduce the environmental impact of the activities on the site.
- 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
- Experience of working with multidisciplinary groups and ability to work within a team environment.
- A good understanding of the drug development process
- Good budget management understanding
- Excellent organizational and project management skills
- Good verbal and written communication 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
- knowledge of SAS programming
- Good level of expertise of oversight and management of external vendors
- diagnostic, analytical and process improvement skills
- Excellent IT and Microsoft Office skills
- Strong attention to detail, excellent and direct communication skills, strong interpersonal skills, and cross-cultural understanding and sensitivity
- Ability to represent the company in a highly professional manner.
- Ability to take initiative with a positive attitude in all circumstances.
- Flexible; independent problem solving and self-direction.
- Eager and interested in learning and growing
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