Clinical Data Manager II

The role

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

What you will do

• Manage clinical trial data management processes from study start up to post database lock
• Act as primary Data Management contact or contributor for assigned projects
• Develop CRF specifications from clinical study protocols
• Conduct database build UAT and maintain quality controlled documentation
• Specify requirements for edit check types
• Create, revise, and maintain data management documentation
• Train clinical research personnel on CRF, EDC, and project items
• Review and query clinical trial data according to the Data Management Plan
• Perform medical coding and coordinate SAE/AE reconciliation
• Liaise with third-party vendors regarding data and deliverables

Required qualifications

• Bachelors and/or a combination of related experience
• 5+ years’ Clinical Data Management experience or demonstrated aptitude in the key skills for the role
• Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
• Able to handle a variety of clinical research tasks
• Excellent organizational and communication skills
• Must be able to read, write, speak fluently and comprehend the English language
• Experience in utilizing a clinical database management system
• Broad knowledge of drug, device and/or biologic development and effective data management practices
• Ability to undertake occasional travel

Nice to have

• Understanding of dictionary medical coding (MedDRA and WHODrug)
• Understanding of CDISC standards (CDASH, SDTM, ADaM, etc…)
• Oncology 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.