Senior Clinical Data Manager/Principal Clinical Data Manager

hace 2 semanas


Madrid, Madrid, España Precision Medicine Group A tiempo completo



Job Summary:

We are seeking a highly skilled Senior Clinical Data Manager to join our team at Precision Medicine Group. The successful candidate will be responsible for managing all aspects of the clinical trial data management process from study start-up to post-database lock for assigned projects.

Responsibilities:

- Manage clinical trial data management processes and ensure timely delivery of high-quality data.
- Oversee database development, testing, and maintenance.
- Collaborate with cross-functional teams to ensure data quality and integrity.
- Develop and maintain data management documentation and ensure compliance with regulatory requirements.
- Provide training and support to clinical research personnel on data management processes and systems.
- Ensure adherence to study-specific data management plans and regulatory directives.
- Perform quality control of data entry and review clinical trial data according to the Data Management Plan.
- Run patient and study level status and metric reporting.
- Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency.
- Coordinate SAE/AE reconciliation.
- Liaise with third-party vendors in a project-manager capacity in support of timelines and data-related deliverables.
- Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities.
- Present software demonstrations/trainings, department/company training sessions, present at project meetings.

Requirements:

- Bachelor's degree in a related field or equivalent experience.
- Minimum of 5 years of experience as a Lead Data Manager for a Clinical Research Organisation.
- Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook.
- Excellent organizational and communication skills.
- Professional use of the English language; both written and oral.
- Experience in utilizing various clinical database management systems.
- Broad knowledge of drug, device, and/or biologic development and effective data management practices.
- Strong representational skills, ability to communicate effectively orally and in writing.
- Strong leadership and interpersonal skills.
- Ability to undertake occasional travel.

About Precision Medicine Group:

Precision Medicine Group is a leading provider of clinical research services. We are committed to delivering high-quality data management solutions to our clients.

What We Offer:

- Competitive salary and benefits package.
- Opportunity to work with a leading provider of clinical research services.
- Collaborative and dynamic work environment.
- Professional development opportunities.

How to Apply:

If you are a motivated and experienced Senior Clinical Data Manager looking for a new challenge, please submit your application.



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