Study Start-Up Manager

ManagerManagerFull TimeRemoteSeniorTeam 10,001+Since 1983H1B SponsorCompany SiteLinkedIn

Location

Turkey

Posted

1 day ago

Salary

0

Seniority

Senior

Bachelor DegreeTurkishEnglishGoogle Cloud Platform

Job Description

Study Start-Up Manager

Parexel

• Manage and conduct study start-up activities in compliance with client procedures, ICH-GCP guidelines, and local regulations • Prepare, review, track, and manage site regulatory documentation at country and site levels • Ensure timely collection and uploading of essential documents into the eTMF (electronic Trial Master File) in accordance with ICH-GCP standards • Coordinate with regulatory authorities and IEC/IRB for submission of applications and required documentation during the start-up period • Maintain, review, and report on site performance metrics and study progress • Update CTMS (Clinical Trial Management System) and other systems with data from study sites according to required timelines • Follow up on outstanding actions with study sites to ensure timely resolution • Collaborate closely with CRAs and Local Study Teams to ensure regulatory and documentation compliance • Support quality control checks to verify that all essential documents are collected and verified prior to site activation • Contribute to clinical and operational feasibility assessments of potential studies • Participate actively in Local Study Team meetings and provide regular updates to line management • Support study selection processes by identifying and assessing potential sites and investigators (as needed) • Take ownership of country-level start-up activities after feasibility completion through site activation • Lead and manage initial clinical trial submissions, ensuring timely preparation, coordination, and follow-up with regulatory authorities and ethics committees • Oversee start-up related budgets and support budget tracking during the start-up phase • Manage and track Import License submissions and ensure timely approvals where applicable • Monitor and coordinate Investigational Product (IMP) and study equipment delivery to ensure site readiness • Drive site activation readiness by ensuring all regulatory, contractual, and logistical requirements are completed • Proactively identify and mitigate risks or delays impacting study start-up timelines.

Job Requirements

  • Bachelor's degree in life science or a related discipline
  • Good knowledge of ICH-GCP and relevant local regulations
  • Proven experience in clinical trial start-up activities at country level, with end-to-end involvement from feasibility completion through site activation
  • Basic understanding of the drug development process
  • Excellent understanding of Clinical Study Management and study start-up procedures
  • Strong hands-on experience in preparing, coordinating, and managing initial regulatory submissions
  • Demonstrated ownership of start-up timelines, with the ability to track, manage, and drive site activation milestones
  • Proven ability to identify start-up risks, manage competing priorities, and implement solutions to ensure timelines are met
  • Experience supporting or overseeing study start-up budgets and financial aspects related to activation
  • Good understanding of local regulatory environment and Ministry of Health procedures
  • Solid understanding of Import License processes and regulatory requirements relevant to clinical trials
  • Experience coordinating Investigational Product (IMP) and study equipment delivery to sites
  • Strong knowledge of essential documents and ability to ensure site readiness, including ISF preparation and inspection readiness
  • Good collaboration and interpersonal skills
  • Fluency in Turkish and English (written and spoken)
  • Excellent attention to detail and accuracy
  • Good verbal and written communication skills
  • Ability to learn and adapt to IT systems
  • Strong organizational and time management skills.

Benefits

  • Opportunity to work on diverse, high-impact clinical trials across multiple therapeutic areas
  • Collaborative and supportive work environment with experienced clinical professionals
  • Professional development and training opportunities
  • Competitive compensation and benefits package
  • Flexible work arrangements
  • Career growth opportunities within a global organization.

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