Offer summary

Qualifications:

Bachelor's degree in life sciences, pharmacy, biology, or related field, or at least 10 years of experience in data management within the pharmaceutical industry., Strong knowledge and technical expertise in Veeva CDMS and CDB systems., Excellent understanding of GCP regulations, clinical data management processes, and pharmaceutical industry standards., Proficiency in English with strong communication, leadership, and problem-solving skills..

Key responsibilities:

Lead and support the implementation of Veeva CDMS and CDB, developing and monitoring related processes.

Coach, mentor, and train the data management team on technical and process aspects.

Act as the primary contact for clients regarding Veeva systems and data management activities.

Ensure compliance with regulatory guidelines and support project delivery from start-up to database delivery.

Job description

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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

The resource will act as Veeva Technical Lead, driving the implementation of Veeva CDMS and CDB at Alira Health, developing, implementing and monitoring Veeva processes. Coach, mentor and train the data management team on Veeva CDMS and CDB. Be primary contact for clients regarding Veeva.

Job Description

ROLE

The Associate Director of Clinical Data Management supports the Senior Director of Clinical Data Management in running the department efficiently, to appropriate quality standards and in line with company strategy. He/She supports commercial development of clinical data management department. The Associate Director of Clinical Data Management leads and drives the DM team, acting as mentor and coach and as the reference point for the Sponsor and the appointed person responsible for the project from the Data Management perspective, to develop the data collection specification from all data sources The Associate Director of Clinical Data Management manages in-stream data flow activities and deliver a quality database in accordance with the project plan, ensures DM tasks for the assigned studies are performed on time and within budget, makes recommendation for process improvement and/or new standards development. The Associate Director of Clinical Data Management is an effective input into strategic planning across the department and bridges scientific or medical knowledge to data management processes to ensure sound data collection tools, validations and integration to fit for purpose clinical datasets department.

KEY RESPONSABILITIES

Strong knowledge of Veeva CDMS and CDB, consolidated and proven technical experience in Veeva
Master Veeva processes and workflows
Strong leadership in defining processes and coordinating tasks in Veeva
Strong leadership in managing Veeva as a supplier and possible other contractors
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.
Coaches and mentors DM resources on process and technical issues. Develops and updates data management processes based on systems used in the department.
Present at external professional/industry organization meetings or conferences.
Represent the DM function in meetings with sponsors (bid defence meetings, kick-off meetings etc.)
Provides pastoral care to the DM team.
Ensures compliance with ICH/GCP guidelines, applicable laws and regulations for all clinical studies.
Supports the DM Director in identifying the resources needed to ensure the successful delivery of projects.
Ensures that the team makes best use of all tools and techniques available.
Supports the DM Director in ensuring the alignment of team member objectives company strategy and objectives.
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.
Accountable for driving achievement of project milestones from study start up through to delivery of database in compliance with project budget.

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.
Strong knowledge on Veeva CDMS and CDB
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