Senior Clinical Data Manager

The role

The Senior Clinical Data Manager manages all aspects of the clinical trial data management process from study start up to post database lock. This role involves overseeing database development, testing, and serving as the primary Data Management contact for assigned projects.

What you will do

• Manage all aspects of the clinical trial data management process from study start up to post database lock
• Serve as primary Data Management contact for assigned clinical projects or programs
• Oversee project data entry process including development of guidelines, training, and quality
• Develop CRF specifications from the clinical study protocol
• Conduct database build UAT and maintain quality controlled database build documentation
• Create, revise, and maintain data management documentation
• Train clinical research personnel on study specific CRF, EDC, and other project items
• Review and query clinical trial data according to the Data Management Plan
• Perform medical coding of medical terms
• Coordinate SAE/AE reconciliation

Required qualifications

• Bachelors and/or a combination of related experience
• 8+ years’ experience as a Clinical Data Manager
• Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
• Able to handle a variety of clinical research tasks
• Excellent organizational and communication skills
• Professional use of the English language; both written and oral
• Experience in utilizing various clinical database management systems
• Broad knowledge of drug, device and/or biologic development and effective data management practices
• Strong representational skills, ability to communicate effectively orally and in writing
• Strong leadership and interpersonal skills

Nice to have

• Experience in a clinical, scientific or healthcare discipline
• Dictionary medical coding (MedDRA and WHODrug)
• Understanding of CDISC standards (CDASH, SDTM, ADaM, etc…)
• Oncology and/or Orphan Drug therapeutic experience

Benefits

• Discretionary annual bonus
• Health insurance
• Retirement savings benefits
• Life insurance
• Disability benefits
• Parental leave
• Paid time off for sick leave and vacation

Before you apply

• Candidates must be legally authorized to work in the country of employment without employer sponsorship

About the company

Precision Medicine Group is an Equal Opportunity Employer.