Senior Clinical Data Manager - Full Service (one sponsor)

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

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.

What you can expect from us

• Office based or home based anywhere in Europe or South Africa.
• Rewarding and meaningful work in an established, diverse, highly profitable and respected global company
• Highly competitive compensation packages, including various local benefits such as pension contributions, complimentary health insurance plans, remote working allowances etc.
• A genuine work life balance
• Flexibility in working hours
• A thorough onboarding with support from your personal mentor
• A permanent employment contract with Fortrea

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.
• 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.

Your profile

• Lead experience across a mix of therapeutic areas.
• 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.
• 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.

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