Clinical Data Leadership Position

6 days ago


Pune, Maharashtra, India beBeeData Full time ₹ 17,37,986 - ₹ 24,35,360
Key Roles and Responsibilities of a Senior Clinical Data Manager

The role of a Senior Clinical Data Manager involves overseeing the entire data operations process, including managing clinical trial data. As a key member of the team, this individual will be responsible for ensuring the accuracy and integrity of clinical trial data.

  • Ensure compliance with regulatory requirements such as HIPAA, FDA, EMA, and ICH-GCP.

Essential Skills and Qualifications:

  • Extensive experience in clinical trial/data management and data operations, with a strong background in electronic data capture systems management.
  • Strong understanding of regulatory requirements and industry standards, including 21 CFR Part 11 compliance.
  • Proven supervisory skills, with at least 4-5 years of people management experience.
  • Deep knowledge of EDC platforms and system integrations, with CTMS configuration and administration skills.

Preferred Qualifications:

  • Experience in pharmaceutical, biotechnology, or CRO environment across multiple therapeutic areas.
  • Knowledge of industry-standard tools and technologies, such as Oracle or SAP.
What We Are Looking For In The Ideal Candidate

The ideal candidate for this role will possess excellent leadership and communication skills, with the ability to work effectively in a fast-paced environment. They will also have a strong analytical mind, with the ability to identify and resolve complex data-related issues.

Additionally, the ideal candidate will have a strong commitment to delivering high-quality results, with a focus on accuracy and attention to detail.

How You Will Make A Difference

As a Senior Clinical Data Manager, you will play a critical role in ensuring the success of our clinical trials. You will be responsible for developing and implementing data quality plans, which will help to ensure compliance with regulatory requirements and deliver accurate and reliable data to stakeholders.

By joining our team, you will have the opportunity to make a real difference in the lives of patients, while also contributing to the advancement of medical research and development.



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