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Study Lead (Clinical Operations - Pharma Research & Early Development)

Little Falls, NJ 07424

Posted: 03/10/2023 Employment Type: Contract Industry: Other Job Number: 11121 Pay Rate: $52.00 - $103.00

Job Description

Our client develops, manufactures, and supplies  wide array of innovative medical diagnostic products, services, tests, platforms, and technologies.  

ROLE PURPOSE:
  • The role of the Study Lead (SL) is to provide leadership for one or more global Study Management Teams responsible for delivering internally managed as well as outsourced First in Man thru Proof of Concept studies.
  • The CRSL is accountable for the strategic and tactical study activities, ensuring high quality execution standards within the agreed budget and timelines.
WHAT YOU WILL DO:
  • Drive study strategy by designing study strategy, integrating the patient voice, driving diversity in enrollment, reviewing/contributing and evaluating executability of study protocol, country selection and data delivery plan, in partnership with cross-functional stakeholders.
  • May be asked to contribute to the strategic development plans occasionally.
  • Lead study teams by providing the operational expertise and thought leadership as a leader of study teams that are accountable for delivering clinical studies; creating and driving study timelines, milestones and budget.
  • Manage risk and compliance by identifying, managing and mitigating risks and issues while ensuring the study team is trained on and adheres to all appropriate standards, including ICH/GCP, SOPs and other regulations.
  • Manage vendor performance by providing direction and oversight for outsourced activities to ensure CRO and vendor delivery against contracted scope of work.
  • Innovate and champion change by driving process improvement, implementing new technologies and participating in supplemental non-project work - e.g., participate in cross-functional initiatives, attend and participate in conferences, ad boards.

Job Requirements

QUALIFICATIONS:
  • Have sound experience in pharmaceutical and/or healthcare industry and drug development experience (therapeutic area experience a plus).
  • Hold a university degree or equivalent years of experience, preferred focus in life sciences.
  • Find passion in achieving successful outcomes by leading, coaching and inspiring others.
  • Want to make a difference and find excitement in innovating practices, therapeutics and processes.
  • Possess strong working knowledge of drug development process and respective regulations.
  • Feel comfortable traveling internationally based on specific program needs
  • Advocate for what you and your team need to succeed.
  • Have a sound understanding and appreciation of the scientific basis for different study types, with the ability to question scientific rationale and practical aspects of protocol design.
  • You are talented and passionate, and are inspired by our mission and would fit in well with our collaborative, patient centric and entrepreneurial spirit.
  • Have a growth mindset and are excited about learning through experience.
  • Feel comfortable thinking on your feet and thrive in fast paced, ambiguous and highly collaborative environments.

Meet Your Recruiter

Jay Hite
Recruiter, Account Manager

As a Recruiter at Compass, Jay enjoys meeting job seekers and helping them to find new and exciting opportunities. He enjoys the process of getting to know candidates and learning all about their experience and what their future goals are. Jay feels the excitement of his candidates and is passionate about helping to find a fit both culturally and professionally. 

When Jay isn’t working, he enjoys bike rides, trying out new foods, tequila tasting and watching movies.  

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