Job ID : 31011
Location : King Of Prussia, PA
Company Name : PVR Technologies Inc
Job Type : Full-Time, Contract, Training
Industry : Biotech/Pharmaceutical
Salary : $55,000 - $65,000 per year
No. of Positions : I Have Ongoing Need To Fill This Role
Required Skills : Clinical Data Manager,Clinical Data Coordinator,
Benefits : Medical Insurance
POSITION – CLINICAL DATA MANAGER
The Clinical Data Manager is an experienced Data Management professional who has worked within a Pharmaceutical or CRO company.
JOB ROLE & RESPONSBILITIES:
Manage CDM activities including Medical Coding, Data Validation Checks, and Database Snapshot
Manage communication with eCRF/database vendors on consistent basis to address clinical team requests and/or eCRF development activities
Provide Clinical Data Management support to cross-functional team
Participate in the review of Clinical Research documents (Protocols and CRS) as needed
Manage and participate in UAT of eCRF build and validation documents, included but not limited to edit check document, issue logs and UAT summary report
Develops/executes/reviews project documentation including but not limited to, data management plan, eCRF Completion Guidelines, Edit Check, Query Logic, UAT, and work instructions for assigned projects
Ensure the quality of clinical data to support study report, IND and NDA submissions meets standards
Manage Study Start-Up: work across several studies to ensure all required documentation is in place in order to authorize sites for study enrollment
Manage and participate in study-specific meetings, teleconferences and training
Collaborate with cross-functional team members and study sites throughout all studies; and
Lead one or more studies at a client.
DESIRED SKILLS & EXPERIENCE
Associate’s degree in computer science, statistics, or equivalent a plus;
Experience with one or more of the leading CDM software applications, e.g., Oracle Clinical, InForm, etc. is required
Minimum 1 year of project lead/project management experience managing projects and/or staff
Experience and knowledge of the drug development process desired
Experience in a clinical development environment
Self-starter who is able to work independently and willing to provide original thinking
Successful team player with good interpersonal, oral and written communication skills
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