Local Trial Manager - Clinical Trials - Remote US

Job Description

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Remote CONUS AK HI

Let’s do this. Let’s change the world. In this vital role you will be the primary point of contact to lead, manage and co-ordinate the conduct of clinical trials from study start-up to close out (CSR/Archival) at a country level in accordance with ICH-GCP and other applicable local regulations. You will maintain the quality and scientific integrity of clinical trials at a local/country level and actively collaborate with cross functional internal and external partners to ensure timely delivery, budget implementation of clinical trial results within the local country.

Key Activities

Partner with global and local country teams to provide high level country strategy and actively drive study progress and local/country level study delivery

Planning, management and oversight of clinical study implementation in accordance with the global program strategy, through leadership with engagement of the cross-functional Local Study Team

Communicate country status (including timelines and results) to key partners including updates to relevant systems for transparency

Provides country level input into the Country Operational Plan and partners with the Development Feasibility Manager through feasibility and with the Global Clinical Managers to ensure local delivery of the study

Support internal audit and inspection activities and contribute to CAPAs, including leading resolution of issues when appropriate e.g., vendor management

Assign and deliver all study support staff and continually review country level risk mitigation to ensure study delivers to plan

Auto req ID

425541BR

Minimum Education Required

High School/GED

Job_Category

Pharmaceutical

Additional Qualifications/Responsibilities

Basic Qualifications:

Doctorate degree or

Master’s degree and 3 years of clinical trial project management experience or

Bachelor’s degree and 5 years of clinical trial project management experience or

Associate’s degree and 10 years of clinical trial project management experience or

High school diploma / GED and 12 years of clinical trial project management experience

Preferred Qualifications

BA/BS/BSc

Minimum 2-3 years’ experience of leading local/regional or global teams

Minimum 2-3 Years’ Clinical Trial Project Management Experience

7 years’ work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company

Experience in management and oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.)

Must be a local/country expert with identifiable project management experience locally

Build strong site relationships as well as other local relationships to ensure end to end study delivery is met.

Salary Range

120,777.00 USD - 140,684.00 USD

City*

United States

State*

N/A

Job Code

Pharmaceutical Pharmaceutical

Affiliate Sponsor

Amgen