Director Operations - Clinical Data Management

Cookie Notice**WHAT -** **Summary & Purpose of the Position****WHAT -** **Main Responsibilities & Technical Competencies**

• Ensuring the correct SOPs, etc., are in place to meet regulatory requirements while providing guidance to CDM staff and partners on how to conduct Ipsen CDM trials;
• Periodic review and revision of CDM documentation;
• Distribution, training, and oversight of training compliance with SOPs, etc., as they are developed or revised;
• Creating, implementing and overseeing a model to evaluate SOP compliance by CDM staff through methods such as review of training records, periodic assessments or audits, and trial-specific / team-specific / vendor-specific “spot checks.”
• Responsible for the recruitment, talent development, line management and supervision of team members in his/her team including objectives definition, appraisal review, and performance management.
• Responsible for building capabilities and technical skills within his/her group to ensure effective, high-quality delivery.
• Member of the Ipsen CDM Leadership team, successfully participating and executing responsibilities as assigned by the Ipsen Head of DMSS.
• Ability to manage large 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 stakeholders
• Ability to produce high quality, accurate work to meet deadlines
• Ability to interact satisfactorily with staff of differing disciplines
• Ability to work across organizational lines and geographies
• Well-developed time management, communication, presentation, analytical and interpersonal skills
• Responsible, flexible and accountable with a pro-active approach
• Experience of managing and developing relationships with Service Providers
• A good understanding of the drug development process
• Approximately 5-7 years of experience in a CDM leadership position with proven Project Management skills in Data Management activities at a development program level
• High knowledge of international standards (ICH, GCP, CDISC ...) and regulations related to clinical studies and data management
• Technical expertise in CDM systems
• Formal change management experience or certification
• Experience working across cultures and geographies
• Good budget management understanding### Get In Touch

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