Trial Manager

Inactive

Reference Number: 896078-W
Type of placement: Contract
Location: CH, NW

Introduction:

The Trial Manager is responsible for supporting the operational management and oversight of clinical trials within their assigned areas. The level of independence and scope of responsibilities assigned may vary depending on the level of experience.

Main Responsibilities:

  • Responsible for supporting the operational management and oversight of clinical trials within assigned countries/regions;
  • Work closely with Clinical Development trial team to support clinical trial-related activities at the country/site level (site initiations and closures, import/export licenses, Trial Master File (TMF), contracts, and invoices);
  • May participate in the selection of EPSs and training of ESP Personnel;
  • Oversee performance of ESPs on a global level to ensure compliance with the clinical study protocol and in accordance with the scope of work (SoW);
  • Proactively identify and resolve issues with ESPs in a timely and efficient manner;
  • Contribute to the development and updating of clinical trial-related risk mitigation and contingency plans, and proactively identify new risks;
  • Support submission to Health Authorities and Independent Ethics ommittees/Institutional Review Boards (IECs/IRBs);
  • Manage and oversee clinical study supplies for assigned countries/regions;
  • Oversee clinical trial progress, assist in resolving issues at a country/region level, identify deficiencies in trial conduct, and define and implement required corrections and corrective actions;
  • Ensure clinical trial information is kept up-to-date in clinical trial management and documentation systems according to assigned area of responsibility;
  • Manage site payments including review and approval of invoices for assigned country;
  • Perform ongoing quality checks/reviews of the (e)TMF(s) and ensure audit readiness in assigned area of responsibility;
  • May assist in the preparation for audits/inspections and implementation of Corrective Action and Preventive Action (CAPA) plans;
  • May provide input into the development of Clinical Study Report;
  • Ensure compliance of all activities in accordance with the clinical study protocol, ICH-GCP, local regulations, and Quality System documents;
  • Oversee adherence to legal, regulatory, and ethical standards and guidelines, including Serious Adverse Event reporting.

Qualifications and Experience:

  • 3 years of demonstrated experience performing international clinical trial management;
  • At least 1 year of Phase II-III experience;
  • Bachelor's degree or equivalent university education/degree, preferably in life sciences or healthcare;
  • Detailed understanding international regulatory requirements for the conduct of clinical development programs in key regions (Americas, Europe, Asia Pacific, and Australia);
  • Experience in managing External Service Providers (ESP);
  • Previous experience working with electronic data capture systems (EDCs), electronic;
  • Trial Master Files (eTMFs), and Clinical Trial Management Systems (CTMSs) is preferred;
  • Fluent in English; fluency in other languages is preferred;
  • Available to travel domestically and internationally;
  • Relevant working/residency permit or Swiss/EU-Citizenship required.