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Director Global Study Management - United States  

Company managed [?] Still accepting applications

Posted on : 07 May 2017

Project Description

The Project Resource Management Director in Global Clinical Project Management responsible for the timely provision of Clinical Trial Management staff, trained and cost effective resources through internal and partner capabilities. The role is expected to be a rotational role, as such the successful candidate is capable of rotating into a Global Clinical Program Management Director role that leads protocol delivery
Lead resourcing, staff management, training and standardization of staff in Global Clinical Program Management (GCPM)
Lead GCPM resource planning and respond effectively to changing priorities
Lead departmental sourcing and FSP management
Provide input in to and manage departmental budgets
Ensure operational efficiency and compliance with R&D standards and training requirements
Support continuous improvement initiatives in GCPM and throughout Global Development Operations (GDO)
Responsible for:
Providing global or regional input to the GSM TA departmental budget
Line management of Senior Manager, PRM staff globally
Hire, manage and effectively allocate study management resources to meet project needs across whole department
Mentoring staff, ensuring staff development and ensuring awareness / standardization of current operating procedures and best practices
The role-based curriculum for GCPM
Representing GSM on process improvement initiatives, Development standards authorship or review

Key Activities
Resource the GCPM Clinical Trial delivery role
Oversight of Functional Service Provider and deliverables
Lead people management, career development, training and succession planning of GCPM staff
Identify training / staff development needs for GCPM and oversee implementation of training plans
Conduct performance management and performance reviews for senior manager, PRM
Identify areas for process improvement within GCPM
Lead / provide input into departmental budgets, headcount, hiring and resourcing
Lead the development of the GCPM role based curriculum
Leads the functional core skills training program and ensures delivery
Lead capability assessments for new corporate partners or FSP vendors
Participate in vendor evaluation and management, represent GCPM at Operational Management Teams (OMT)
Manage functional goal setting
Facilitate sharing of best practices and product knowledge within the function
Contribute to development and maintenance of policies, SOPs and associated documents
Represent the function by contributing and / or leading initiatives for the continuous improvement of clinical trial planning and execution
Contribute to capability assessments for new vendors and participate in vendor qualification assessments

Decision Making Authority
Financial approval consistent with grade
Department budget
GCPM resourcing
Department role-based curriculum
Recruitment and development of GCPM staff

Knowledge:
Knowledge of global regulatory requirements and guidelines for conducting clinical research and safety monitoring / reporting
Strong external provider management experience, working with CRO partners.
Project and Program management including oversight of study deliverables, budgets and timelines
Time, cost and quality metrics
Relevant operational expertise
Understanding of resource management and organizational capacity
Experience in developing goals and training plans to maximize talent and career development of staff
Experience of managing projects in a matrix organization
Ability to network and build relationships to maximize organizational function and capabilities
Experience in leading organizations through change

Competencies:
Departmental Leadership
People Management
Project Management
Strategic Operational Planning
Relationship Management and negotiation and influencing skills
Innovation
Decision Making
Conflict Management
Written and Oral Communication
Scientific / Technical Excellence
Financial Management
Flexibility / Adaptability

Basic Qualifications
Doctorate degree and 4 years of Global Clinical Project Management experience OR
Master’s degree and 8 years of Global Clinical Project Management experience OR
Bachelor’s degree and 10 years of Global Clinical Project Management experience and 4 years of direct managerial and/or leadership experience

Preferred Qualifications
M.D., D.O., PhD, PharmD, MSc
11 years’ work experience in life sciences or medically related field, including 8 years of biopharmaceutical clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company
Previous management experience of direct reports, including management level staff
Experience at or oversight of outside clinical research vendors (CRO’s, central labs, imaging vendors, etc.)

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.