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Local Study Associate Director- FSP (Turkey)

Remote: 
Full Remote
Contract: 
Salary: 
6 - 6K yearly
Experience: 
Mid-level (2-5 years)
Work from: 

Offer summary

Qualifications:

Bachelor's degree in life science or equivalent, Minimum 3 years in Development Operations, Experience in trial oversight or leadership, Knowledge of ICH GCP and local regulations.

Key responsabilities:

  • Lead Local Study Teams for clinical studies
  • Ensure sites are qualified, initiated, and monitored
  • Take responsibility for study commitments
  • Deliver data on time and quality
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Parexel Pharmaceuticals XLarge http://www.parexel.com/
10001 Employees
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Job description

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Parexel FSP is hiring a Local Study Associate Director to join us on a  

permanent full-time, home-based basis.

If you’re driven by the potential of science to create meaningful change and

eager to explore your capabilities, join us.

Dedicated to a single sponsor in BioPharma, who is revolutionizing healthcare by harnessing the power of science to benefit people, society, and the planet. Turkey is a vital part of their global network, hosting colleagues from every segment of the life sciences value chain. Their science-driven approach aims to transform healthcare and improve patient outcomes, while also fulfilling a purpose-led role in society.

As a Local Study Leader you will lead Local Study Teams(LST) at the country level to deliver clinical studies according to agreed resources, budget, and timelines complying with procedural documents, international guidelines as well as relevant local regulations.

In addition to leading LST(s), ) may perform accompanied site visits as needed to support the flexible capacity model.

Responsible for ensuring that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.

  • Overall responsibility for the study commitments within the country, for timely delivery of data to required quality as per SMA

  • Lead Local Study Team(s) consisting of CRAs, start-up specialists, and study administrator(s).

ESSENTIAL REQUIREMENTS

  • Bachelor’s degree in a related discipline, preferably in life science, or equivalent qualification.

  • Experience in trial oversight/leadership role.

  • Minimum 3 years of experience in Development Operations (CRA, SrCRA) or other related fields (Medical Affairs-led or Academic-led studies).

  • Good knowledge of international guidelines ICHGCP as well as relevant local regulations.

  • Proven ability to lead and motivate cross-functional teams to deliver clinical trials according to or ahead of time plan, budget, and with required quality.

  • Excellent project management skills.

Apply today!

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Required profile

Experience

Level of experience: Mid-level (2-5 years)
Industry :
Pharmaceuticals
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Leadership
  • Team Motivation

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