EU ONLY-Principal Clinical Data Manager

Clinical Data Manager-EU BASED ONLY

Main responsibilities/ Job Expectations

Related to study activities:

• 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.
• 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.
• Ensure that the Data Management activities related to collection, processing and data transfers to the client 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.
• 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 client rules and standards (e.g. standard database within client 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).

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 area

Knowledge, abilities & experience

Experience:

• 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.
• 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.

Qualification :

• 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

Key Technical Competencies Required

• 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
• 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