Local Study Associate Director

hace 2 semanas

Bogotá, Bogotá D.E., Colombia AstraZeneca A tiempo completo

Description

:

The Local Study Associate Director is accountable for ensuring site identification, qualifications, setup, monitoring, closure, and document archiving.

To oversee Local Study Team(s) (LSTs) at the country level to deliver assigned parts of clinical studies within set resources, budget, and timelines, in compliance with AZ Procedural Documents, ICH-GCP guidelines, and relevant local regulations. Besides leading LST(s), the Local Study Associate Director (LSAD) may conduct site monitoring to support the flexible capacity model.

Responsibilities:

  • Overall responsibility for study commitments and timely delivery of data at the country level.
  • Leading the Local Study Team, including CRA(s) and CSA(s), for assigned study/studies.
  • Optimizing the performance of Local Study Team(s) at the country level for compliance with AZ Procedural Documents, ICH-GCP, and local regulations.
  • Ensuring high-quality clinical and operational feasibility assessments for potential studies.
  • Coordinating site selection by identifying sites/investigators, conducting Site Qualification Visits, and assessing suitability and quality risks.
  • Collecting and verifying essential trial documents before study start in line with AZ SOPs.
  • Planning and coordinating local drug activities.
  • Setting up and maintaining the study in CTMS and local websites as per regulations.
  • Overseeing, managing, and coordinating monitoring activities from site activation to closure.
  • Reviewing monitoring visit reports and advising on study-related matters.
  • Identifying risks, resolving study problems, and managing stakeholders effectively.
  • Developing and maintaining risk management plans at the country study level.
  • Communicating regularly with National Co-ordinating Investigator/National Lead Investigator on study matters.

Requirements:

  • Bachelor's degree in a related field, preferably in life sciences, or equivalent.
  • Minimum 3 years of experience in Development Operations (CRA, SrCRA) at AstraZeneca.
  • Strong knowledge of ICH-GCP guidelines and local regulations.
  • Proven leadership skills to drive cross-functional teams in delivering clinical trials efficiently.
  • Excellent project management, team building, and communication skills.
  • Outstanding organizational and attention to detail skills.
  • Proficiency in spoken and written English.
  • Good negotiation skills and ability to work with IT systems.
  • Willingness to travel nationally and internationally as necessary.

Date Posted

23-May-2024

Closing Date

04-Jun-2024

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