Senior Clinical Data Manager – Late Phase (Role can be 100% remote anywhere in Europe)
Do you have experience leading data management activities across late phase studies? Are you looking for a new challenge in an environment where you be closely supported by your Manager, peers and Senior Leaders in your team? Perhaps you are seeking to gain further experience in new therapeutic areas, recent studies in the team include;
Oncology – breast cancer (Phase III), Global, 6000 subjects
Oncology – rare cancers in paediatric population (III), Global, 300 subjects
Cardiovascular – adaptive design (IIa), USA, 200 subjects
Respiratory (IIa), Europe, 400 subjects
Internal medicine – registry study (IV), Europe and US, 800 subjects
Infectious disease – Covid treatment (IV), Middle East, 4000 subjects
Join our growing team and discover your extraordinary potential by working as a Senior Clinical Data Manager within our Global Clinical Development department.
The position offers a strong support network, flexible working solutions and the opportunity to progress your career. If you are looking to strengthen your Lead Clinical Data Management expertise within a varied and dynamic environment, then this is a fantastic opportunity. The vast majority of the team work remotely 100% but depending on your location, there is opportunity to have some office contact, perhaps 1 or 2 days per week.
In this opportunity, you will:
Serve as the technical leader on all data management aspects for project(s) including start-up, maintenance, and completion activities.
Develop global Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data.
Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and forecasts.
Serve as the project and client liaison including management and provision of project specific data management status, cycle time, and productivity metrics.
Coordinate and participate in the development of the clinical data model and/or database design and annotate the CRF (eCRF) according to these specifications.
Review data acquisition conventions and data review guidelines / diagnostic specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCRF) completion / monitoring conventions.
Coordinate the development and testing of data management systems edit / data validation checks) diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities.
Interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical support, drug safety, etc.) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality.
Advanced planning and risk management for projects (issue escalation, resource management).
Oversee the technical performance of the data review project staff on achieving client satisfaction through delivery of quality data, on-time and on-budget.
Assist with goal creation and performance review assessment for data review project staff.
Maintain technical data management competencies via participation in internal and external training seminars.
Ensure project staff are trained and adhere to project-specific, global, standardized data management processes.
Identify areas for process and efficiency improvement and implement solutions on assigned projects.
Support achievement of project revenue and operating margin for data management activities to agreed targets.
Support business development for data management time and cost estimates and prepare and present to potential clients on global data management capabilities.
Education
University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
Additional relevant work experience will be considered in lieu of formal qualifications.
Your profile:
Lead experience across a mix of therapeutic areas.
EDC experience – ideally you will have RAVE experience and experience across other EDCs would be advantageous.
Excellent oral and written communication and presentation skills.
In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations.
Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.
Ability to lead by example teams on project strategies and achievement of department goals, objectives, and initiatives and to encourage team members to seek solutions.
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
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