We are delighted to be recruiting a Clinical Data Manager to join our team at Coronado Research, working with Jo Marshall and our Data Science and Advanced Analytics team.
Coronado Research is a consultancy-led, professional services organisation, which provides support to pharmaceutical, biotechnology, and medical device companies. As science changes, we are seeing the traditional clinical development model being replaced by a more targeted, precision-based approach. The introduction of new technologies, including tools leveraging Artificial Intelligence (AI) and Machine Learning, and novel methodologies is leading to a changed research paradigm.
At Coronado Research, we are dedicated to advancing pharmaceutical research through cutting-edge clinical trials, providing expert-driven advice and support. We are creating developmental processes that match the latest science, looking at the end-to-end process, optimising the research continuum, and placing data at the centre.
Role Overview
We are seeking a proactive and resourceful Clinical Data Manager to support data management activities for a variety of different clinical development programs. This role is pivotal in ensuring the integrity, quality and timeliness of clinical trial data while maintaining compliance with industry regulations. The Clinical Data Manager will support all DM activities through trial set up, conduct and lock, working with cross-functional stakeholders to ensure seamless collaboration and data accuracy.
Key Responsibilities
Data Management Study Participation: Conduct all clinical data management activities, including data collection, validation, cleaning, medical coding and reconciliation processes.
Data Management set-up: Contribute to the design, development, and review of Case Report Forms, Data Management and Data Review Plans and other study set up activities.
Data Validation & Quality Control: Take responsibility for the execution of data validation activities to ensure data consistency, accuracy, and completeness, EDC checks, data listings and other data review tools to ensure data integrity.
Vendor Data: Manage receipt and reconciliation of external data, ensuring deliverables meet quality, regulatory, and timeline expectations.
Issue Resolution & Support: Troubleshoot data-related issues and provide hands-on support to internal and external stakeholders.
Cross-Functional Collaboration: Work closely with clinical operations, biostatistics, and programming teams to align data management activities with overall study objectives.
Documentation: Ensure that documentation required to demonstrate regulatory compliance are maintained accurately.
Regulatory Compliance: Ensure adherence to Good Clinical Practice (GCP), ICH guidelines, and regulatory requirements (FDA, EMA).
Study Review & Reporting: Participate in data review meetings, contribute to database lock, and support clinical study report preparation.
Industry Best Practices: Stay up to date with emerging trends and best practices in clinical data management.
Skills and Experience Required
Bachelor's degree in Life Sciences, Biotechnology, or a related field.
Proven experience in clinical data management within a biotech, pharmaceutical, or CRO environment.
Hands-on expertise with key clinical data management systems.
Knowledge of Good Clinical Practice (GCP), ICH guidelines, and global clinical trial regulations.
Excellent logical, analytical and problem-solving skills with a creative and curious approach to help drive innovation.
Good customer focus, able to prioritise the needs and satisfaction of our customers and deliver quality data.
Ability to work both independently and collaboratively in a fast-paced, cross-functional environment, and to hold yourself and others to account for appropriate ethical behaviour and inclusivity.
Dependable and a commitment to maintaining high data quality standards through a conscientious approach.
This role is ideal for an clinical data professional established with all data management activities who thrives in a collaborative environment and is passionate about advancing clinical research through high-quality data management practices.
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