Clinical Operations Lead

Vor 4 Tagen

Basel, Basel-Stadt, Schweiz Recordati Vollzeit
Clinical Trial Leadership

We are a leading pharmaceutical company, dedicated to developing and commercialising innovative medicines that improve human health. Our Clinical Trial Liaison Managers play a vital role in ensuring the successful conduct of clinical trials, working closely with cross-functional project teams to deliver high-quality results.

As a CTLM, you will be responsible for overseeing site and country trial delivery and performance, including subject recruitment, adherence to protocol and regulations, and timely delivery of high-quality data. You will work closely with CRAs, Site Coordinators, and other trial team members to ensure successful trial conduct.

Key Responsibilities:

  • Act as an ambassador for Recordati, supporting its positioning as a sponsor of choice.
  • Drive enrolment at the Principal Investigator level and work closely with CRAs and Site Coordinators to ensure they understand the PI's enrolment strategy.
  • Facilitate collaboration between different departments or groups within the same trial site to optimise the enrolment of trial subjects.
  • Oversee and track patient recruitment for sites and pro-actively identify ways to prevent recruitment delays.
  • Ensure data quality and data integrity meet GCP and local regulations through data review (remote and onsite).
  • Conduct Sponsor Oversight Monitoring Visits (SOVs) to ensure accurate and compliant monitoring by the CRO and study progress visits to trial sites.
  • Maintain accountability for long-term operational partnerships with key sites, providing local intelligence.
  • Pro-actively identify issues and look for solutions in the assigned clinical trial and timely escalate them to the Lead CSM, CSM vendor/CRO or Local CSM.

Requirements:

  • Bachelor's degree (or international equivalent) in pharmaceutical science, chemistry, biology, medical/healthcare or comparable background.
  • Excellent communication and presentation skills, with relationship management of multiple stakeholders, internally and externally.
  • Leadership with the ability to overcome challenges, seek opportunities to remove barriers, influence without authority.
  • Highly developed organisational skills, problem-solving, analytical, and able to prioritise.
  • Experience with tools and systems for managing clinical studies.

Language Requirements: English and French fluent written and spoken. Any additional language is considered beneficial.

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