Director of Data Management, US and Canada

As Director of Data Management, US you will run the Clinical Data Management department efficiently, to appropriate quality standards and in line with company strategy, supporting commercial development of Alira Health Data Management in the US and Canada.

ESSENTIAL JOB FUNCTION

• Define processes for DM tasks and ensure adherence and compliance
• Is responsible for the quality of the outputs/deliveries of the department and for managing the resources effectively.
• Coaches and mentors DM resources on process and technical issues. Develops and updates data management processes based on systems used in the department.
• Define baseline standard estimates for DM tasks.
• Ensures function KPIs are identified and maintained.
• Responsible for the timely delivery and quality of all DM activities.
• Present at external professional/industry organization meetings or conferences.
• Represent the DM function in meetings with sponsors (bid defence meetings, kick-off meetings etc.)
• Manages possible complaints/SOP deviations regarding the DM department.
• Ensures compliance with ICH/GCP guidelines, applicable laws and regulations for all clinical studies.
• Identifies the resources needed to ensure the successful delivery of projects.
• Ensures that the team makes best use of all tools and techniques available.
• Ensures alignment of team member objectives company strategy and objectives.
• Ensures Department KPI are met and properly manages the professional growth of the resources of his/her department.
• Responsible for the development of the capabilities and skills necessary to meet current and future data management needs.
• Develop training plans and induction plans in compliance with the Training Matrix.
• Solves data quality issues that may arise in internal audits, assessments or inspections by sponsors or health regulatory authorities.
• Reviews Budget Proposals
• Reports problems and critical issues to the direct superior.

JOB REQUIREMENTS

Preparations, Knowledge, Skills and Abilities

• Degree in life sciences, pharmacy, biology or related field or at least 10 years of experience in the data management field in a pharmaceutical or equivalent environment.
• At least 5 years of experience in equivalent position with technical leadership and managerial accountabilities
• Strong knowledge of GCP regulations and procedures
• Strong knowledge of Data Management processes
• Broad understanding of the pharmaceutical industry and the clinical development process
• Knowledge of study related regulations and guidelines relating data management and associated best practices