• Study Start-Up Lead

    Job Locations (All) | US-Remote
    Posted Date 8 hours ago(8/13/2019 4:04 PM)
    ID
    2019-55990

Overview

REMOTE BASED ROLE

Who We Are:
We Are PRA.

We are 16,000+ employees strong, operating in more than 90 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most.

Who You Are:


You are a highly-motivated clinical research professional who capitalizes on your critical thinking skills to reach target deliverables. You are efficient with your time and have a keen ability to manage priorities in a fast-paced environment while maintaining a high standard of quality deliverable output. You are a self-starter ready to lead your study and team through a pivot trial timepoint by making time sensitive, data-supported decisions. You are a confident communicator that is able to capitalize on your ability to challenge the status quo and your project management skills to independently create solutions to complex issues.

In your next career move, you want to work for a company that supports your professional growth and helps you find a work/life balance. You want to expand your knowledge, develop your skill set, and build your career. Most of all, you want to do it in a place where you are part of a team as zealous about their work as you are - a place where you can really make a difference.

Responsibilities

What will you be doing:

You will be a key leader of the Study Start-Up team. You will:

  • Oversee the execution of all start-up related activities through last site activated according to study strategy
  • Collaborate cross-functionally with global team members to ensure site activation success and present risk mitigation strategies at executive-level meetings
  • Exhibit the ability to perform root cause analysis and determine mitigation steps to removing critical path roadblocks
  • Exhibit sound decision-making skills, utilizing all available resources for determining positive outcomes
  • Communicate with investigative sites and internal team members to forecast timelines for site activation and ensure all activation requirements are met
  • Implement process improvements to mitigate risks to activation timelines
  • Adjust quickly to the changes of a dynamic organization and work to foster positive change management
  • Update systems in a timely and accurate way
  • Be highly organized in an environment with shifting priorities
  • Analyze data and metrics relating to the site activation pathway
  • Be responsible for driving increased efficiencies yielding a decrease in site activation cycle times

Qualifications

What You Need to Have:

  • Minimum 5 years of industry experience or equivalent regulatory experience required
  • Significant experience in managing and in meeting agreed on targets on clinical deliverables during the start up phase of a project.
  • Preferred: 2-3 years of Start Up Lead experience
  • Undergraduate degree, health related preferred OR, an equivalent combination of education and experience sufficient to successfully perform the key responsibilities of the job
  • Familiarity with Microsoft Outlook, Word and Excel
  • Clinical trials support or pharmaceutical industry experience preferred
  • Knowledge of ICH and local regulatory authority drug research and development regulations preferred
  • Ability to read, write and speak fluent English required
  • To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

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6 days ago - source

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