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Senior Local Study Manager

Synthorx

Synthorx

Taipei City, Taiwan
Posted on Nov 29, 2024

About the job

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Job purpose:

  • Coordinates / supervises all the tasks generated by clinical trials and which are entrusted by the CSU Head.

  • Ensures that these trials are carried out according to the required quality standard deadlines and to the CSU’s commitments.

  • Represents a privileged link between the Study Teams and the CSU within the timeframe of these clinical trials.

Main responsibilities:

  • Participate in the assessment of the trial feasibility.

  • Make a selection of investigators.

  • Prepares the file submission to the Health Authorities and the Ethical Committee.

  • Prepares the investigators’ contracts.

  • Prepares the clinical trial AED/budget.

  • Writes / validates the technical and/or administrative documents which are necessary for the trial and makes the Corporate documents fit the local regulations.

  • Organizes the local investigators meetings when appropriate.

  • Ensures the good initiation of the centers, especially makes sure that the investigates are perfectly information of the trial specifications and of its organization.

  • Ensures a good follow-up of the centers by co-monitoring visits, assessing the monitoring reports and following the recruitment.

  • Participates locally to the setting up of the audits carried out by the Corporate; coordinates the answers and follows up the possible correcting actions.

  • Ensures good IP management together with the IP manager.

  • Checks the payment of the investigators fees.

  • Ensures that tolerance items are collected and reported.

  • Makes sure that centers are properly closed with files archiving and IP & trial material collection.

  • Keeps the investigators and the Health Authorities informed of the trial’s results.

  • Ensures the update of CTMS.

  • Participate in the allocation of trials within the CSU.

  • Train the CRAs and CPA to the study’s specificities.

  • Coordinates the activity of the CRAs working on the study.

  • Cares for the implementation of the study’s instructions.

  • Ensures the setting up of the study’s file inside the CSU.

  • Informs the CSU Head of the progress of the trial and of the difficulties encountered, makes a review with him of the adequate strategy to be set up.

  • Makes sure that the Study Teams receive all required data on the trial progress.

  • Participates in the meetings related to the trial and organized by the Study Teams.

About you

  • Education: Bachelor degree or above in clinical medicine or pharmacy.

  • Minimum 6 years experience in clinical study and 1.5 years experience in project management.

  • Proven experience in local site management would be added value.

  • Good command of English and Mandarin (written and spoken).

  • Knowledge of PC (WORD, EXCEL, POWERPOINT).

  • Interpersonal communication skill.

  • Team player.

  • Strong planning and organization skill.

  • Good project leadership and management skill.

Why choose us?

  • Bring the miracles of science to life alongside a supportive, future-focused team.

  • Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!