Job Description
General Summary:
The Clinical Trial Management Principal is responsible for managing single-region trials of high complexity or leading large multi-center global clinical trials across a range of study phases (including real world evidence based studies) and therapeutic areas. The role is also responsible for contributing to Clinical Trial Management department initiatives, often as leader.
Key Duties and Responsibilities:
Coordinates internal and external clinical trial management activities of all assigned study team members involved in the study planning, start up, conduct, and closure of assigned clinical trials or study regions.
Assists Clinical Operations Program Lead (COPL) or global Clinical Operations Study Lead (gCOSL) in the development of operational strategy and initial timeline.
Creates detailed study timeline with minimal support; monitors progress of timeline with cross-functional Study Team input.
Drives study level operational strategy, overseeing development and execution of study operational plan(s).
Drives cross-functional vendor identification and set up and ensures appropriate ongoing oversight.
Manages approved trial budget(s) including ongoing vendor invoice reconciliation and scope of work review; works cross-functionally to initiate vendor contract changes and review revised scope of work and budgets.
Takes lead role in investigator identification and selection.
Contributes significantly to the development of study documentation including clinical trial protocols, study plans and clinical study reports.
Proactively identifies study risks and implements contingency plans with minimal supervision.
Participates in cross functional study data review where appropriate.
Represents Clinical Trial Management department as a technical resource in cross-functional initiatives or process improvement efforts (e.g. SOP and WI updates), often as leader.
Acts as a resource for clinical trial management staff with less experience.
May function as representative for Clinical Trial Management on vendor-related Joint Operating Committees.
Knowledge and Skills:
Strong clinical trial management track record showing clear proficiency in project management skills, cross-functional study operations and vendor management.
In-depth understanding of GCP, CFR and ICH Guidelines.
Demonstrates detailed understanding of clinical protocol, intended study populations and drug development.
Demonstrates ability to effectively interface with key medical personnel at investigational site(s).
Excellent interpersonal skills and communications skills to explain difficult information and works to build alignment.
Ability to effectively problem solve within a cross-functional team.
Demonstrates ability to effectively manage issue identification and resolution.
Excellent attention to detail.
Ability to work successfully under pressure with tight timelines.
Proficiency in Microsoft Office applications including Outlook, Excel, Word, and PowerPoint.
Approximately 25% travel to research sites and investigator meetings.
Education and Experience:
Bachelor's degree in life sciences discipline or relevant discipline.
Typically requires 8 years of relevant work experience in the biopharmaceutical industry, or the equivalent combination of education and experience.
Pay Range:
$136,000 - $204,000
Flex Designation:
Remote-Eligible
Company Information:
Vertex is a global biotechnology company that invests in scientific innovation.
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