Clinical Trial Management Principal Lazio

Clinical Trial Management Principal
Roma
Lazio, Lazio

Job Description

The Clinical Trial Principal is responsible for managing single or multiple region clinical trials of mínimal to moderate complexity or managing regional-based activities on large global trials across a range of study phases and therapeutic areas.

Key Responsibilities:

- Supports 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 execution of operational strategy and supports initial timeline development

- Creates detailed study timeline with moderate support and oversight; monitors progress of timeline with cross-functional Study Team input

- Executes study or regional level operational strategy; supports development and execution of operational plan(s)

- Supports COPL or gCOSL on cross-functional vendor identification; may be delegated set up and oversight activities for certain vendors

- Supports review of approved trial budget(s) as assigned by COPL or gCOSL, including ongoing vendor invoice reconciliation and scope of work review; works cross-functionally to support vendor contract changes and review revised scope of work and budgets

- Supports COPL or gCOSL with managing investigator identification and selection for assigned clinical trials or study regions

- Contributes to the development of study documentation as assigned including clinical trial protocols, study plans and clinical study reports

- Manages study risks and implements contingency plans with moderate supervision

- Assists with cross functional study data review when assigned

- Acts as a team member for department level or cross-functional initiatives or process improvement initiatives.

Key Requirements:

- Knowledge in project management skills and cross-functional study operations

- Expanded understanding of GCP, CFR and ICH Guidelines

- General experience with vendor management set up and oversight

- Demonstrates understanding of clinical protocol, intended study populations and drug development

- Demonstrates ability to effectively interface with key medical personnel at investigational site(s)

- Proficient interpersonal and communication skills to explain complex information in straightforward information

- Ability to effectively problem solve within a cross-functional team

- Demonstrates ability to identify issues and resolve with guidance as needed

- Excellent attention to detail

- Ability to work successfully under pressure with tight timelines

- Bachelor's degree in life sciences discipline or relevant discipline.

Company Information

- Vertex is a global biotechnology company that invests in scientific innovation.

- Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.

Vertex is an E-Verify Employer in the United States.

Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.