Local Study Associate Director

2 days ago

Bhilai, Chhattisgarh, India PAREXEL International Ltd Full time ₹ 90,00,000 - ₹ 1,20,00,000 per year
Job Description

Parexel FSP is hiring Local Study Associate Directors to join us on a permanent full-time, home-based basis.

The role requires working in a hybrid model, with 3 days/week at the sponsor's office (Istanbul, Ankara, or Izmir).

If youre 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 Local Study Associate Director, 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), the Local Study Associate Director (LSAD) may visit sites as needed to support the flexible capacity model.

The LSAD is 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
  • Bachelors degree in a related discipline, preferably in life science, or equivalent qualification.
  • Minimum 3 years of experience in Development Operations (CRA, SrCRA) or other related fields (Medical Affairs-led or Academic-led studies).
  • Experience of ICF preparation essential.
  • Experience of leading clinical trials.
  • At least 1 year of project management experience is a key requirement.
  • 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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