Join Our Team as a Senior Clinical Data Manager

Precision Medicine Group is looking for a seasoned Senior Clinical Data Manager to oversee all aspects of clinical trial data management. This pivotal role encompasses everything from study start-up to post database lock, ensuring all processes adhere to SOPs, regulatory guidelines, and specific project requirements.

Key Responsibilities:

As the Lead Data Manager, your day-to-day responsibilities will include:

• Acting as the primary contact for data management on assigned clinical projects, guaranteeing quality, responsiveness, and timely execution of tasks.
• Developing and overseeing data entry guidelines, training, and quality assurance.
• Creating CRF specifications in line with the clinical study protocol and managing database development and testing.
• Assessing project timelines and resourcing needs, and ensuring all clinical data management deadlines are met with precision.
• Coordinating serious adverse event (SAE) and adverse event (AE) reconciliation.
• Managing data management documentation for Trial Master File accuracy and completeness.
• Providing leadership in cross-functional and organizational initiatives.

Essential Skills and Qualifications:

Minimum Requirements:

• Bachelor's degree or relevant experience in data management.
• Minimum of 8 years' experience in a similar role.
• Expertise in Microsoft Office and clinical database management systems.
• Exceptional organizational and communication skills.

Preferred Qualifications:

• Background in clinical, scientific, or healthcare discipline.
• Familiarity with medical coding dictionaries (MedDRA and WHODrug).
• Understanding of CDISC standards (CDASH, SDTM, ADaM).
• Experience in oncology or orphan drug therapeutics.

Why Precision Medicine Group?

At Precision Medicine Group, we are committed to advancing the field of precision medicine. We are an Equal Opportunity Employer and believe in creating an inclusive environment. We make decisions without regard to race, color, religion, sex, national origin, disability, or any other protected class.

If you require a reasonable accommodation to complete your application, please contact us at [email protected].

Apply Now!

Are you ready to lead and innovate within a top-notch clinical data management team? Apply today and join us in shaping the future of medicine!

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