Medical Site Manager

4 tygodni temu

Warszawa, Mazovia, Polska PSI Pełny etat
Job Description

This is a unique opportunity for an experienced professional to join our team as a Medical Site Manager at PSI.

About the Role:

We are seeking a highly skilled and organized individual to oversee the day-to-day operations of clinical trials at our medical site. The ideal candidate will have excellent communication skills, be able to work independently, and possess a strong attention to detail.

Responsibilities:

  • Act as the primary point of contact between the Sponsor/CRO and the medical institution.
  • Built strong relationships with medical staff and Sponsor/CRO representatives involved in clinical trials.
  • Facilitate the evaluation of proposed studies and ensure timely responses to feasibility questions.
  • Assist in scheduling, preparation, and conduct of monitoring visits at the medical institution.
  • Participate actively in all types of monitoring visits conducted at the medical institution.
  • Track enrollment and support the medical site team to meet enrollment targets.
  • Maintain study-specific and general tracking documents at the site level.
  • Ensure accurate and timely data entry into EDC systems and resolve data clarification queries.
  • Support timely reporting and follow-up on Adverse Events, Serious Adverse Events, and Protocol Deviations.
  • Properly handle, account for, and reconcile investigational products and clinical supplies.
  • Collect and maintain site-specific documents needed by the Sponsor/CRO for submission to authorities.
  • Facilitate contract and budget negotiations at the site level.
  • Oversee and manage Investigator and Site payments at the site level.
  • Ensure the medical site team completes necessary study-specific and general training prior to involvement in clinical trials.
  • Ensure ongoing quality in clinical trials by adhering to study requirements and ensuring data generated by the site is fully supported by source documents.
  • Prepare the medical institution for audits or inspections and participate actively during these events.

Qualifications:

  • A University degree in Life Science, preferably in pharmacy, nursing, or lab analytics.
  • Certified GCP training.
  • Full proficiency in Polish and intermediate English language proficiency.
  • Proficiency in MS Office applications.
  • A valid category B driver's license.

Benefits:

This role offers a competitive salary of $80,000 - $100,000 per annum, depending on experience, plus additional benefits including health insurance, retirement plan, and opportunities for professional growth and development.

Location: This position is based in Warsaw, Poland.

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