Clinical Data Manager/Senior Clinical Data Manager Job Opportunity

Join our team at Precision for Medicine as a Clinical Data Manager/Senior Clinical Data Manager. Drive excellence in clinical trial data management from study start-up to post-database lock for assigned projects. Adhere to Standard Operating Procedures (SOPs), regulatory directives, and study-specific plans and guidelines.

Key Responsibilities

Core Functions:

• Serve as the primary Data Management (DM) contact for assigned clinical projects, ensuring task continuity, responsiveness, and timely completion. Provide backup support as needed.
• Oversee all aspects of the data entry process, including guidelines development, training, quality control, and resource management.
• Develop Case Report Form (CRF) specifications based on clinical study protocols, ensuring stakeholder feedback is incorporated.
• May assist in database development and perform quality control checks.
• Manage timelines to ensure deadlines are met with high quality. Assess and allocate resources accordingly.
• Review and query clinical trial data following the Data Management Plan guidelines.
• Conduct database build User Acceptance Testing (UAT) and maintain quality-controlled documentation.
• Liaise with third-party vendors and support project deliverables.

Qualifications

Minimum Requirements:

• Bachelor's degree or equivalent combination of related experience.
• 8+ years of experience in clinical data management.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Excellent organizational and communication skills.
• Strong command of written and spoken English.
• Experience with various clinical database management systems.
• Comprehensive understanding of drug, device, and biologic development.
• Strong leadership, interpersonal, and representational skills.
• Willingness to undertake occasional travel.

Preferred Qualifications:

• Experience in clinical, scientific, or healthcare disciplines.
• Familiarity with Dictionary Medical Coding (MedDRA and WHODrug).
• Understanding of CDISC standards (CDASH, SDTM, ADaM).
• Background in Oncology and/or Orphan Drug therapeutic areas.

About Precision Medicine Group

Precision Medicine Group is dedicated to providing equal employment opportunities. We celebrate diversity and are committed to creating an inclusive environment for all employees. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

If you require reasonable accommodation to complete any part of the application process, please contact us at .

For detailed information on our data privacy practices, please view our and .

Join us to make a significant impact in clinical data management. Be part of a team dedicated to advancing precision medicine.

Company Name: Precision Medicine Group

Job Title: Clinical Data Manager/Senior Clinical Data Manager