21 days old

Clinical Study Planning Mgr

Amgen
Thousand Oaks, CA 91360
  • Job Code
    114997065
Amgen

Job ID: R-86806
Location: Thousand Oaks, CA, US 91360

The Clinical Study Planner 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. The Clinical Study Planner partners with the Resource Forecasting Group to ensure optimized planning of resources and budget.

This is a global role based in Global Development Operations (GDO).

Responsibilities:
  • Lead the development of and monitor the implementation of high-quality, realistic, cross-functional, global clinical trial timelines, from design through final study reporting, in Amgen's planning systems within specified deadlines
  • 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 RAP, annual LRS, quarterly LE, etc.)
  • Maintain accuracy of clinical study timeline information in Amgen data control systems (e.g., Planisware PPM), through conducting integrity checks and data issue resolution on a routine basis for assigned study timelines
  • Partner with Resource Forecasting Group staff to support optimized planning of resources and budget.
  • Communicate information on clinical trial status, changes, and issues to stakeholders, and confirm acceptance of clinical study timelines with functional representatives ensuring alignment with key operational goals and timelines
  • Increase the efficiency of trial operations through the sharing of cross-program knowledge and identification of best practices leading to standardization across the organization
  • Create scenario options in support of decision-making for operational or strategic direction
  • Participate in (or lead) process improvement initiatives as assigned


Basic Qualifications:

Doctorate degree

OR

Master's degree and 3 years of Clinical experience

OR

Bachelor's degree and 5 years of Clinical experience

OR

Associate's degree and 10 years of Clinical experience

OR

High school diploma / GED and 12 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)
  • PMP Certification
  • Drug development knowledge with understanding of other functions, including Pre-Clinical, Clinical, Development Operations, and Regulatory
  • Project management tools and processes (e.g., MS Project, Planisware, PowerPoint)
  • Strong computer literacy, including word processing, presentation, and spreadsheet applications
  • Experience with resource capacity planning tools and methodologies


Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

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.

Work alongside the best. Be part of our highly talented, hard-working teams. Their spirit is what fuels our success.

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.

PI114997065

<b>Amgen</b><br/><br/><b>Job ID: </b>R-86806<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>The Clinical Study Planner 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. The Clinical Study Planner partners with the Resource Forecasting Group to ensure optimized planning of resources and budget.<br><br>This is a global role based in Global Development Operations (GDO).<br><br>Responsibilities:<br><ul><li>Lead the development of and monitor the implementation of high-quality, realistic, cross-functional, global clinical trial timelines, from design through final study reporting, in Amgen's planning systems within specified deadlines</li><li>Manage, implement and communicate changes per the Change Impact Assessment Review & Approval (CIARA) process or other mechanisms as appropriate</li><li>Ensure alignment of funding/investment of clinical studies within assigned programs to support operational planning by functions (ie, via monthly RAP, annual LRS, quarterly LE, etc.)</li><li>Maintain accuracy of clinical study timeline information in Amgen data control systems (e.g., Planisware PPM), through conducting integrity checks and data issue resolution on a routine basis for assigned study timelines</li><li>Partner with Resource Forecasting Group staff to support optimized planning of resources and budget.</li><li>Communicate information on clinical trial status, changes, and issues to stakeholders, and confirm acceptance of clinical study timelines with functional representatives ensuring alignment with key operational goals and timelines</li><li>Increase the efficiency of trial operations through the sharing of cross-program knowledge and identification of best practices leading to standardization across the organization</li><li>Create scenario options in support of decision-making for operational or strategic direction</li><li>Participate in (or lead) process improvement initiatives as assigned</li></ul><br><br>Basic Qualifications: <br><br>Doctorate degree<br><br>OR<br><br>Master's degree and 3 years of Clinical experience<br><br>OR<br><br>Bachelor's degree and 5 years of Clinical experience<br><br>OR<br><br>Associate's degree and 10 years of Clinical experience<br><br>OR<br><br>High school diploma / GED and 12 years of Clinical experience<br><br>Preferred Qualifications: <br><ul><li>BA/BS/BSc in the sciences or RN</li><li>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)</li><li>PMP Certification</li><li>Drug development knowledge with understanding of other functions, including Pre-Clinical, Clinical, Development Operations, and Regulatory</li><li>Project management tools and processes (e.g., MS Project, Planisware, PowerPoint)</li><li>Strong computer literacy, including word processing, presentation, and spreadsheet applications</li><li>Experience with resource capacity planning tools and methodologies</li></ul><br><br>Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.<br><br>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.<br><br>Work alongside the best. Be part of our highly talented, hard-working teams. Their spirit is what fuels our success.<br><br>Join Us <br> <br> 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. <br> <br> 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. <br> <br> 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. <br> <br> 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.<br/><br/> <img src="https://analytics.click2apply.net/v/m6rryQIbe8XeTKlqs4m2Z"> <p>PI114997065</p>

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Posted: 2019-10-31 Expires: 2019-12-01

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Clinical Study Planning Mgr

Amgen
Thousand Oaks, CA 91360

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