Offer summary

Qualifications:

Degree in life sciences, pharmacy, biology, or related field., At least 10 years of experience in the data management field, with 5 years in a managerial role., Strong knowledge of GCP regulations and data management processes., Excellent communication skills and ability to manage conflict effectively..

Key responsibilities:

Run the Clinical Data Management department efficiently and ensure compliance with quality standards.

Supervise and mentor the data management team, ensuring effective resource management.

Define and monitor KPIs for the department and ensure timely delivery of all DM activities.

Represent the DM function in meetings with sponsors and at industry conferences.

Job description

🔗Are you being referred to one of our roles by a connection in Alira Health? If so, please apply using the referral link emailed to you.

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.

Job Description Summary

Support Alira Health Data Management in process improvement, review of SOPs and GDs, mentoring and coaching of DM resources, support to projects and any other activity as deemed necessary.

Job Description

ROLE

The Director of Clinical Data Management runs the Clinical Data Management department efficiently, to appropriate quality standards and in line with company strategy. To support commercial development of Alira Health Clinical Data Management.

KEY RESPONSABILITIES

Define processes for DM tasks and ensure adherence and compliance.
Supervises the activities of the data management team in terms of technical aspects and pastoral care.
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.
Monitors the non-billable time spent in the DM department.
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.
Provides pastoral care to the DM team.
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.

DESIRED QUALIFICATION & EXPERIENCE

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