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Parexel

Parexel is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Local Study Associate Director

DirectorDirectorFull TimeRemoteSeniorTeam 10,001+Since 1983H1B SponsorCompany SiteLinkedIn

Location

Israel

Posted

13 days ago

Salary

0

Seniority

Senior

Bachelor Degree5 yrs expEnglishGoogle Cloud Platform

Job Description

Local Study Associate Director

Parexel

• Responsible at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Client Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations • Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in client clinical studies financial system by regular checks of the system and financial reports • Leads and optimizes the performance of the Local Study Team(s) at country level ensuring compliance with client Procedural Documents, ICH-GCP and local regulations • Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant client SOPs and local regulations • Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study

Job Requirements

  • Minimum of 5 years trial management experience (as COL or CTM)
  • Local experience, SSU oversight, end to end experience, oncology trial experience
  • Previous experience in site monitoring
  • 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
  • Experience performing submissions to RA and EC
  • Experience partnering with study functions to ensure smooth delivery
  • Effective time management, organizational and interpersonal skills & problem-solving skills, with the ability to multi-task and prioritize
  • Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines

Benefits

  • Premium salary
  • Attractive benefits
  • Car or car allowance
  • Medical care plan: Health, Dental & Vision
  • Life Assurance
  • Excellent work environment
  • Culture of teamwork and collaboration
  • Innovative technology
  • Excellent training

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