Job description

Job Description

ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps.

Remote CONUS AK HI

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

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

439075BR

Minimum Education Required

High School/GED

Job_Category

Health/Medical other

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.

126,432.00 USD - 144,987.00 USD

City*

United States

State*

N/A

Job Code

Pharmaceutical Pharmaceutical

Affiliate Sponsor

Amgen

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