Please, make sure to upload your updated cv in english.
overview
:
the analytical monitor is responsible for a range of tasks that spans the areas of targeted data analytics, risk identification & mitigation at site & subject level.
the analytical monitor is an individual contributor role that supports the execution of analytical monitoring activities that will enable site managers to perform guided issue/ risk management.
the analytical monitor supports execution of processes and activities for multiple clinical trials in conformance to all relevant laws, regulations, guidelines, policies, and procedures.
the analytical monitor collaborates closely with site managers, other data management & central monitoring roles, & other internal partner functions and/or external service providers to achieve successful, cooperative partnerships.
responsibilities
:
conducts activities in compliance with sponsor functional sops, processes and policies.
facilitates smooth and effective communication, managing multiple communication streams. Follows agreed escalation pathways where needed.
may support innovation or process improvement projects which may include but are not limited to participation in requirements development, user acceptance testing and identification of improvements to existing and new analytical tools & processes.
performs analytical monitoring activities for clinical trials within assigned scope of responsibility in line with portfolio timelines and priorities, including support of execution and close-out as outlined in the end-to-end process.
analytical monitors will conduct regular (fit for purpose) reviews at site and subject level that will help early detection of issues, and prevent recurrence
collaborates closely with the site manager and central monitoring manager to action trends and signals detected at the site and subject level.
accesses various systems, databases and reporting tools to identify potential risks related to the site and subject level data quality, study participant safety and compliance by identifying trends and early warning signals
provides timely analytical data insights to support the site managers in making decisions on site prioritization and critical engagement.
requirements/qualifications
:
bachelor's degree (e.g., bs, ba) or equivalent professional experience is required, preferably in health sciences or data sciences
approximately 3+ years of experience in pharmaceutical, cro or biotech industry or related field or industry
experience with data analysis
knowledge of clinical drug development within the pharmaceutical industry or related industry
working knowledge of regulatory guidelines (e.g., ich-gcp).
experience working with technology platforms and systems used for the collection, analysis and reporting of data.
ability to collaborate in an environment of cross-functional stakeholders, plan and coordinate tasks effectively.
ability to communicate effectively in english (written and verbal).
preferred experience
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familiarity with basic risk management, project management, and/or statistical concepts.
basic knowledge of central monitoring and risk-based quality management (rbqm)/risk-based monitoring (rbm)/quality by design (qbd) concepts
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