Clinical Data Manager

3 hours ago


South Plainfield, New Jersey, United States Katalyst Healthcares and Life Sciences Full time

Clinical Data Manager

**Key Responsibilities**

As a Clinical Data Manager at Katalyst Healthcares and Life Sciences, you will serve as the primary liaison between our company and Contract Research Organizations (CROs) for data management. Your expertise will be instrumental in providing support and oversight to the CRO Data Management team, ensuring seamless collaboration on study design, protocol development, CRF design, statistical planning, and CSRs.

**Responsibilities Include:**

* Reviewing clinical study protocols and providing comments as needed
* Providing leadership and support for cross-functional tasks, processes, and training
* Managing relationships with external vendors
* Overseeing data management documentation, data management plans, CRFs, study database specifications, data validation plans, edit check specifications, data transfer specifications, data issue logs, and data review plans to ensure compliance with study design and regulatory requirements

**Requirements**

To be successful in this role, you will need:

* A Master's degree or higher in a science-related discipline
* A minimum of 5 years of CDM experience in the pharmaceutical/biotech industry
* Practical experience with successful submissions and product approvals from global regulatory authorities across multiple therapeutic areas
* Thorough knowledge of data management processes, including EDC and IWRS experience
* Good working knowledge of regulatory guidelines such as GCP, 21 CFR Part 11, etc.

**What We Offer**

As a Clinical Data Manager at Katalyst Healthcares and Life Sciences, you will have the opportunity to work with a talented team of professionals who share your passion for delivering high-quality data management services. We offer a dynamic and supportive work environment, competitive compensation, and opportunities for professional growth and development.



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