Senior Clinical Data Manager - Late Phase
LabCorp
Athens, Greece
πριν από 19 ώρες

Senior Clinical Data Manager Late Phase (Role can be 100% remote)

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 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 (, nursing certification, medical or laboratory technology).

    Additional relevant work experience will be considered in lieu of formal qualifications.

    Experience

    Lead experience across late phase studies.

    Ideally you will also experience across a range of therapeutic areas.

    EDC experience experience across multiple EDC systems 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.

    MORE INFORMATION AVAILABLE ON REQUEST - please reach out to Antony McAteer () or connect with me - / .

    Keywords :

    Labcorp Drug Development, Covance by Labcorp, Covance, Chiltern, Phases IIb-IV, CRO, Contract Research Organisation, Contract Research Organization, pharma, pharmaceutical, clinical data manager, clinical data management, Clinical Data Management, Late Phase, Clinical Data Management, home based, pharma, home-based, flexible working, flexible location, field based, home based EU Anywhere, anywhere in Europe, field-based, United Kingdom, UK, Great Britain, England, Maidenhead, Reading, Berkshire, Birmingham, Cambridge, Sheffield, Manchester, Alderley Edge, Scotland, Edinburgh, Wales, Swansea, Northern Ireland, Austria, Belgium, Bulgaria, Czech Republic, France, Paris, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Netherlands, Leiden, Poland, Portugal, Romania, Slovakia, Bloemfontein, Centurion, South Africa, Madrid, Barcelona, Spain, #LI-Remote, Remote, EMEA

    Labcorp is proud to be an Equal Opportunity Employer :

    As an EOE / AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

    For more information about how we collect and store your personal data, please see our Privacy Statement.

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