Amgen

Senior Manager, Global Clinical Program Resources Management

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Mar 22, 2019
Ref
R-70004
Required Education
Associate Degree
Position Type
Full time
A global role within Global Development Operations (GDO), reporting to the Director, Global Clinical Program Management; Head of Program Resource Management. The Senior Manager will lead and manage the Global Clinical Program Management Functional Service Provider (GCPM FSP) partnership for a GCPM Hub and will also be responsible for performance managing a team of Amgen staff.

Responsibilities:

Functional quality and business oversight of GCPM staff (Regular Full Time Staff and Functional Service Provider), including Global Clinical Trial Manager (GCTM), Regional Clinical Trial Manager (RCTM), Clinical Trial Specialist (CTS) and Study Management Associate (SMA)

Critical analysis of key functional performance indicators to mitigate potential risks

Effective and efficient issue management in a cross functional matrix

Line management, performance management, and mentoring of GCTM (RFT) staff

Ensure Global Clinical Program Management staff (RFT and FSP) adherence to operating standards and promoting standardization and best practice sharing to ensure compliance and operational efficiencies

Provide input into the learning management system and Role Based Curriculum makeup in GCPM

Oversee resourcing and allocation of GCTM, RCTM, and CTS staff

Lead GCPM on strategic staff-focused process improvement initiatives; Development standards authorship and/or review

Basic Qualifications:

Doctorate degree and 2 years of clinical trial management experience in a Biopharmaceutical Sponsor or Clinical Research Organization setting

OR

Master's degree and 6 years of clinical trial management experience in a Biopharmaceutical Sponsor or Clinical Research Organization setting

OR

Bachelor's degree and 8 years clinical trial management experience in a Biopharmaceutical Sponsor or Clinical Research Organization setting

OR

Associate's degree and 10 years of clinical trial management experience in a Biopharmaceutical Sponsor or Clinical Research Organization setting

OR

High school diploma / GED and 12 years of clinical trial management experience in a Biopharmaceutical Sponsor or Clinical Research Organization setting

Preferred Qualifications:

BS/BA/BSc in the sciences or RN

9+ years work experience in life sciences or medically related field, including 6+ years of biopharmaceutical clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company

2+ years of direct managerial and/or leadership experience

Experience at, or oversight of, outside clinical research vendors (CRO's, central labs, imaging vendors, etc.)

Advanced knowledge of global clinical trial management, processes, and operations

Extensive knowledge of ICH/GCP regulations and guidelines

Project and Program management including oversight of study deliverables

Understanding of resource management and organizational capacity