Clinical Study Planning Mgr

  • Company: Amgen
  • Posted: October 25, 2016
  • Reference ID: 1305374194
Career Category

Job Description
The Clinical Study Planning role within Global Development Operations drives cross functional planning and effective execution of studies through the development of realistic study timelines and objective communication of project status to maximize global therapeutic value. This individual achieves results through rigorous goal setting, accountability measures, effective teamwork, performance management, collaboration with other groups and a commitment to serving customers both inside and outside of GDO.

Key Activities include, but are not limited to:
  • Manage the development of and monitor the implementation of high-quality, realistic, cross-functional, global clinical trial timelines in Amgen's planning systems within specified deadlines
  • Conduct integrity checks and data issue resolution on a routine basis for assigned study timelines
  • Manage, implement and communicate changes per the Change Impact Assessment Review & Approval (CIARA) process or other mechanisms as appropriate
  • Ensure alignment of funding/investment of clinical studies within assigned programs to support operational planning by functions (ie, via monthly Rolling Approvals Process, annual Long Range Planning, quarterly Latest Estimates, etc.)
  • Stay abreast of latest developments in drug development and contribute to advances in the practice of project management (continuous improvement)
  • Maintain strong working relationships with study teams
  • Collaborate on issues identification and resolution with study teams (e.g., identify bottlenecks)
  • Ensure alignment with Integrated Project Plan
  • Inform management and stakeholders on status of and/or issues regarding program(s)/study timelines
  • Compile program or study-related information for use with or deliver to internal or external groups
  • Participate in (or lead) process improvement initiatives as assigned
  • Monitor progress against study plans and against established process metrics
  • Confirm acceptance of clinical study timelines with functional representatives ensuring alignment with key operational goals and timelines
  • Create scenario options in support of decision-making for operational or strategic direction

Basic Qualifications
Doctorate degree
Master's degree and 3 years of clinical experience
Bachelor's degree and 5 years of clinical experience
Associate's degree and 10 years of clinical experience
High school diploma / GED and 12 years of clinical experience

Preferred Qualifications

  • Proficient project management skills, including but not limited to effective meeting management, ability to manage team(s) to accomplish increasingly complex, specific projects, and ability to navigate through a complex team or matrix environment
  • Excellent oral and written communication skills, including ability to influence and motivate others outside of direct line of authority, strong ability to interface effectively with all levels, proficient facilitation, negotiation, problem-solving, and conflict resolution skills
  • Ability to organize, interpret, communicate and/or present team information within a function/department and occasionally to external groups (e.g., TA heads, review boards)
  • BA/BS/BSc in the sciences or RN
  • 5+ years of 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)
  • Strong computer literacy, including word processing, presentation, project management, and spreadsheet applications
  • Drug development knowledge with understanding of other functions, including Pre-Clinical, Clinical, Development Operations, and Regulatory
  • Quick learner; proactive; takes initiative
  • Skilled in understanding and planning in highly ambiguous situations
  • Results oriented and goal driven
  • Demonstrates willingness to put in extra effort when necessary to pursue tasks to conclusion
  • PMP Certification

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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.


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