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Clinical Project Planner / Scheduler (MS Project)

Employer
Regeneron Pharmaceuticals, Inc.
Location
Tarrytown, NY, United States
Start date
May 16, 2019

View more

Discipline
Clinical, Clinical Research
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work

Job Details

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary:
The Master Scheduler/ Planner works closely with stakeholders to plan, develop, monitor, and control the schedule for a clinical study.

Job Duties:

Schedule Planning and Development: Includes the processes to plan the work to be performed and develop a schedule for a clinical study plan clinical study.

Work with stakeholders (e.g., resources from Therapeutic Area Project Management (TAPM), Clinical Trial Management (CTM), Clinical Sciences (CS), Clinical Finance, etc.) to do the following:

• Determine and document stakeholder needs and requirements to meet the objectives of a clinical study

• Identify assumptions

• Define and validate scope

• Create a Work Breakdown Structure (WBS) that establishes the framework of what must be delivered

• Define Activities: Identify the specific actions to be performed to achieve the objectives of a clinical study by referencing a standard list of activities in a template.

• Decompose work packages into schedule activities to provide a basis for estimating, scheduling, executing, monitoring, and controlling the work.

• Sequence Activities: Identify and document relationships among the activities to obtain the greatest efficiency given all constraints. Define the logical sequence of work to support a realistic and achievable schedule.

• Estimate Activity Durations: Estimate the number of work periods needed to complete individual activities with estimated resources.

• Develop Schedule: Analyze activity sequences, durations, resource requirements, and schedule constraints to create the schedule.

• Generate a schedule model with planned dates for completing clinical study activities. Identify the critical path. Publish the schedule.

• Schedule Monitoring and Controlling: Includes the processes to establish a schedule baseline, monitor progress, report schedule status, control changes, and optimize the schedule for a clinical study.

• Baseline Schedule: Establish a schedule baseline that can be used as the basis for comparison to actual results.

• Monitor Schedule: Collect activity status at defined intervals from activity owners via reports and meetings to compare actual vs. planned performance.

• Report Status: Use industry standards, guidelines, and best practices to identify and report schedule status, changes, impacts, or issues.

• Generate and maintain visibility of the schedule and the associated milestones for a clinical study in the milestone dashboard.

• Provide verbal and written schedule status updates to maintain schedule awareness

• Communicate schedule issues that could impact delivery of scope or adherence to the schedule baseline, to elevate awareness to relevant stakeholders.

• Control Schedule: Document and manage changes to the schedule baseline, received through formal change-control processes, to maintain an accurate schedule.

• Incorporate approved activities into the schedule, by utilizing defined change control processes, to establish a new schedule baseline.

• Conduct performance reviews to measure, compare, and analyze schedule performance against the schedule baseline.

• Perform trend analysis by examining project performance over time to determine whether performance is improving or deteriorating.

• Perform variance analysis to determine the cause and degree of difference between the schedule baseline and actual performance.

• Optimize Schedule: Identify alternative execution options for a clinical study, using tools and techniques such as "what-if" scenario analysis.

• Stakeholder Engagement: Includes those processes to manage and monitor stakeholder engagement for a clinical study.

• Manage Stakeholder Engagement: Communicate and work with stakeholders to meet their needs and expectations, address issues, and foster appropriate stakeholder involvement to enhance support for the schedule.

• Monitor Stakeholder Engagement: Monitor stakeholder relationships and tailor strategies for engaging stakeholders through modification of engagement strategies and plans.

#LI-LR1, LMR

Requirements:

Education

• Bachelor's degree

Experience

• A minimum of 5 years' experience planning and scheduling clinical studies

• Proficient with MS-Project

• Drug development or clinical development pharmaceutical industry experience preferred, but not required

• Project Management Institute (PMI) Scheduling Professional (PMI-SP) or Project Management Professional (PMP) certifications preferred, but not required

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
LMR, Schedule, project schedule, master scheduler, clinical schedule, clinical trial planner, #Li-LR1

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States

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