Director, Clinical Data Management

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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 

TECHNICAL COMPETENCES & SOFT SKILLS 

• English, Excellent 

• MS Office Suite, Good

• Understanding of international cultures

• Ability to develop future plans and goals for the department

• Professional  

• Trustworthy 

• Ability to effectively prioritize 

• Quality focused 

• Personable Attitude 

• Willingness to learn 

• Team Player 

• Effective Stress Management Techniques 

• Learning Agility 

• Ability to Manage Conflict  

• Problem Solving Skills 

• Effective Verbal Communication Skills 

• Commercial and Technical Writing Skills

• Networking Skills 

• Ability to Provide Constructive Feedback

• Analytical thinking 

• Resilient 

• Ability to Influence and motivate 

• Ability to manage difficult conversations 

• Innovative 

• Excellent Presentation Skills 

• Commercial awareness 

• Ability to recognize and develop talent

Languages

English

Education

Bachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): Pharmacy

Contract Type

Contingency Workforce