Clinical Systems and Analytical Reporting Manager - Thousand Oaks, CA | Biospace
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Clinical Systems and Analytical Reporting Manager

Amgen

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Location:
Thousand Oaks, CA
Posted Date:
12/7/2016
Position Type:
Full time
Job Code:
R-29172
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

The Clinical Systems and Analytical Reporting Manager will have the following

responsibilities:

Data analysis of clinical trial operational data and its relationships with processes to support clinical trial performance management

Integration of visual data views to inform the review and interpretation of information

Support study team activities, operating reviews, and management requests through the delivery of information to support decision making

Design of data capture tools/applications to support tracking of key operational data

Review of data quality activities to assure appropriate stewardship of data

Model major business processes to drive a common understanding of business needs across stakeholder groups

Develop plans, partner with suppliers, communicate progress and escalate issues ensuring effective stakeholder management

Delegate tasks to assigned staff and/or contractors that support larger deliverables and projects

Review and suggest improvements to CAAS guidance documents based on experience to ensure accurate representation of current processes

Execute special projects and assignments Responsible For:

Data analysis done in a rigorous manner through the use of application and analytical development methodologies suitable for a validated environment

Deliver fit for purpose deliverables incorporating knowledge of Clinical Trial processes

Ensure appropriate documentation for areas of responsibility

Develop best practice procedures and processes based on lessons learned

Plan and execution of necessary activities to deliver CAAS services Key Activities

Data analysis of clinical trial operational data and its relationships with processes to support clinical trial performance management

Integration of visual data views to inform the review and interpretation of information

Support study team activities, operating reviews, and management requests through the delivery of information to support decision making

Design of data capture tools/applications to support tracking of key operational data

Review of data quality activities to assure appropriate stewardship of data

Model major business processes to drive a common understanding of business needs across stakeholder groups

Develop plans, partner with suppliers, communicate progress and escalate issues ensuring effective stakeholder management

Delegate tasks to assigned staff and/or contractors that support larger deliverables and projects

Requirements

Basic Qualifications:

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 10 years of clinical experience

OR

High school diploma / GED and12 years of clinical experience

Preferred Qualifications:

BA/BS/BSc in the sciences or RN

5+ years work experience in life sciences or medically related field, including 4+ years of biopharmaceutical clinical product development (clinical research or clinical operations experience obtained at a biotech, pharmaceutical or CRO company)

Previous management experience of direct reports

Strong understanding of the concepts of clinical research and drug development

Strong understanding and experience in the use of performance management techniques, measurement and visualization

Strong understanding of principals of customer service as it applies to internal and external customers

Advanced computer and system operation skills

Continuous improvement principles and their application e.g., Six Sigma and understanding of project management software

Good organizational and planning skills

Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements

Familiar with other Data Management systems (IVR, EDC, etc.)

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential