Clinical Data Manager - Remote

Job Description

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Remote CONUS AK HI

In this vital role you will be the Project Lead within Global Study Operations Data Management (GSO DM) and report to the Senior Manager-GSO Data Management. Amgen GSO-DM is strategically resourced with external vendor support through a functional service provider (FSP) model. The Data Manager taking this role will partner with cross functional study teams as well as the FSP to ensure product delivery of the Amgen Therapeutic Area portfolio.

Global Study Operations (GSO) – Data Management plans and implements the capture, cleaning and storage of all Amgen clinical study and trial management data.

Specific Responsibilities Include But Are Not Limited To

Project level coordination of and day to day oversight of DM tasks including: Review all DM documents within a project area to ensure a consistent approach and review of project timelines and metrics to ensure databases are delivered to set timelines, and approve database locks and unlocks.

Ensure that quality control checks are occurring such that quality databases are delivered.

Develop and co-ordinate project level training for data management staff.

Review and approve study specific training and lead vendor results and relationship at the project level.

Communication of project level issues including processes, timelines, resourcing, performance, etc.

Review of all study level non-DM documents for awareness and project level consistency.

Lead electronic submission activities and assist with response to questions and findings from Clinical Quality Assurance (Quality Assurance) and other audits at the study / vendor level.

Lead or participate in the development, review and implementation of processes, policies, SOPs and associated documents affecting DM.

Auto req ID

429302BR

Minimum Education Required

High School/GED

Job_Category

Medical

Additional Qualifications/Responsibilities

Doctorate Degree

Or

Master's Degree and 2 years of clinical experience

Or

Bachelor's Degree and 4 years of clinical experience

Or

Associate's degree and 8 years of clinical experience

Or

High school diploma/GED and 10 years of clinical experience

Preferred Qualifications

Degree in life science, computer science, business administration or related field.

Clinical Data, Project and Planning Management experience in the Pharmaceutical or Biotech industry.

Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, etc.).

Salary Range

118,946.00 USD - 144,923.00 USD

City*

United States

State*

N/A

Job Code

Pharmaceutical Pharmaceutical

Affiliate Sponsor

Amgen