Clinical Data Manager

Kapadi is a full service CRO that focuses on complex oncology indications including immunotherapy and cellular therapies. Innovative research requires innovative operations and we’ve built that into our culture, systems and processes. As we continue to grow, we are looking for a highly-motivated Clinical Data Manager to help us deliver new, life-changing therapies for the patients with cancer who need them.

Are you ready to think outside the box and drive results?

As a Clinical Data Manager, you will:

• Be responsible for all data management tasks and documentation through the duration of a study.
• Develop study plans in accordance with Good Clinical Practices (GCP) and assure compliance by vendors.
• Conduct data review; manage coding, database build and UAT activities as assigned for clinical database.
• Write and resolve manual data queries.
• Perform data reconciliation (e.g., vendor, SAE) including coordination of transfers and issue resolution with other functional areas and/or 3rd party vendor.
• Investigate and resolve reviewer-reported data issues from statistical, medical or sponsor reviews.
• Perform database lock activities at study conclusion.

Knowledge, skills and abilities:

• Demonstrated knowledge of the clinical research and development process in pharmaceutical and/or biotechnology industries.
• Demonstrated ability to manage and conduct the design, build, and test activities related to Electronic Data Capture system development, including case report forms, dynamic functions, and edit checks.
• Excellent knowledge of Electronic Data Capture systems, supporting CDISC-based technology, and data management processes.
• Demonstrated experience in client service in the clinical research business.
• Ability to develop study-specific procedures.
• Ability to create detailed DM project instructions and documents (CRF Completion Guidelines, database design documents, edit check specifications, data review plan, etc.)

Requirements:

• Bachelor’s Degree (or equivalent) level of qualification in Life Sciences, Medicine, Pharmacy, Nursing, or equivalent combination of education and experience.
• Minimum of 2 years of experience in clinical R&D in pharmaceutical, biotechnology and/or clinical research organization (CRO) businesses.
• At least 2 years of experience in a CRO providing clinical research services to pharmaceutical, biotechnology or medical device companies, or equivalent experience, including 1 year of experience in function similar to data management.

Location: Remote - US

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