
Senior Clinical Operations Manager
5 days ago
The Senior Clinical Data Manager role encompasses a range of responsibilities, including data management activities, EDC build, coding, query management, external data reconciliation, SAE reconciliation, EDC testing, writing test scripts, and data cleaning.
Main Responsibilities- Perform and assist in data management activities such as data validation, discrepancy review, query resolution, and reconciliation to ensure accuracy and completeness.
- Act as backup to the Lead Clinical Data Manager and lead studies independently if required, providing guidance and support to team members.
- Support the preparation of study-specific procedures, including data management plans (DMP), clinical coding guidelines (CCG), and other relevant documents.
- Create data transfer agreements when necessary to facilitate the exchange of data between parties.
- Participate in study kick-off meetings to discuss project objectives, timelines, and resource allocation.
- Review Case Report Forms (CRFs) and edit check specifications to ensure compliance with regulatory requirements.
- Ensure all deliverables meet quality standards and customer expectations by implementing effective quality control measures.
- Lead or support team members in their work, providing coaching and mentoring to improve performance and productivity.
- Communicate effectively with sponsors, sites, and other departments to facilitate data collection and resolve any issues that may arise.
- Assist in tracking and managing projects, identifying risks, and taking corrective actions to mitigate potential problems.
- Provide training on basic data management skills to new team members to enhance their knowledge and capabilities.
- Perform User Acceptance Testing (UAT) to verify that systems and processes meet functional and operational requirements.
- Demonstrated ability to communicate effectively in English in person, by phone, and in writing.
- Proven leadership skills, including the ability to lead functional meetings and manage multiple projects simultaneously.
- Strong attention to detail and accuracy, with the ability to maintain high levels of precision and quality in work products.
- Excellent organizational skills, with the ability to prioritize tasks, manage time, and meet deadlines.
- Ability to work collaboratively and productively in diverse organizational structures, with a focus on teamwork and collaboration.
- Ability to work independently, take initiative, and complete tasks to deadlines, while maintaining a positive attitude and adaptability in a fast-paced environment.
- Ability to analyze complex situations, identify solutions, and implement effective strategies to drive results and achieve goals.
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