Covance Job - 31862410 | CareerArc
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Company: Covance
Location: Durham, NC
Career Level: Associate
Industries: Healthcare, Pharmaceutical, Biotech


Job Overview:

IXRS PM/ Validation Lead

Home or Office based in the US or Canada

Main Responsibilities:

• Oversee outsourced electronic trial operations systems (e.g. NRS , eCOA) that are implemented within a trial

• Proactive follow-up with client and Third Party Vendor to ensure comprehensive understanding of study design and technology design (may involve a kick-off meeting with various stakeholders) with a view to
providing quality deliverables.
• Involvement from Creation of the Request for Proposal up to Creation of the User Acceptance Testing (UAT) Plan, directing the execution of the test scripts, manage defect tracker leading eventually to System Go-Live. Same
responsibilities, post production release. Deliverables therefore include but not limited to :
Coordinating the review and approval of Company and Allergan generated documents (Business Requirement Documents, Configuration specs, Project Management Plan, UAT Plan, Study Manuals and Guides)
Tracking of documentation
Maintenance of the TMF for Company Related documentation 0 Adherence to Clinical Planning timelines for System release 0 Representing the COMP-EDS group on Clinical Study Team meetings
• Respond to and solve technical oriented problems as appropriate


Bachelors Degree


• Proficiency in converting business function needs and reference documents into complete and comprehensive systems specifications
• Proficiency in converting complex technical and business requirements into an understandable test plan and test cases
• Experience with clinical systems, such as CTMS, ePRO, EDC, NRS, Inform or other related technology in the pharmaceutical/biotechnology industry

 Apply on company website