
Clinical Data Leadership Role
21 hours ago
As a senior clinical data manager, you will play a pivotal role in the management and oversight of clinical trial data operations.
- Lead a team of data managers to ensure timely and accurate delivery of high-quality data
- Collaborate with cross-functional teams to develop and implement data management strategies that meet regulatory requirements and ensure compliance
- Develop and maintain CTMS platforms, including configuration, administration, and validation
- Analyze and resolve complex data-related issues, ensuring seamless project execution
You will be responsible for managing and supervising a team of data managers. This includes:
- Ensuring timely and accurate delivery of high-quality data
- Mentoring and developing team members to enhance their skills and knowledge
- Collaborating with cross-functional teams to identify areas for process improvement and implementing changes to increase efficiency and productivity
Key Responsibilities also include:
- Developing and maintaining CTMS platforms
- Configuring and administering CTMS systems
- Validating CTMS systems to ensure accuracy and reliability
In addition, you will need to have strong analytical skills to analyze and resolve complex data-related issues. You must be able to work independently and as part of a team to ensure seamless project execution.
Requirements:
- 10-15 years of experience in clinical trial/data management and data operations
- Minimum 4-5 years of people management experience with proven supervisory skills
- Extensive experience with CTMS platforms (CRIO, RT CTMS, Veeva Vault CTMS, or similar)
- Strong background in EDC systems management and clinical data operations
- Experience in pharmaceutical, biotechnology, or CRO environment across multiple therapeutic areas
Technical Expertise:
- CTMS configuration and administration skills
- Deep knowledge of EDC platforms and system integrations
- Strong understanding of regulatory requirements (HIPAA, FDA, EMA, ICH-GCP)
- Experience with electronic systems validation and 21 CFR Part 11 compliance
Preferred Qualifications:
- Knowledge of CRIO platform an advantage
- Experience working with diverse therapeutic areas
We are looking for a highly motivated and experienced senior clinical data manager to join our team. As a key member of our organization, you will be responsible for managing and supervising a team of data managers. The ideal candidate will have a strong background in clinical trial/data management and data operations, with at least 10-15 years of experience in the field.
The successful candidate will have excellent leadership skills, with the ability to motivate and mentor team members to achieve their full potential. They will also have strong analytical skills, with the ability to analyze and resolve complex data-related issues.
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a highly motivated and experienced senior clinical data manager, we encourage you to apply for this exciting opportunity.
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