Study Manager – Germany in Berlin, Germany

Translational Research in Oncology (TRIO) is a global academic clinical research organization dedicated to advancing translational cancer research in the clinical trial setting. Our passionate team is committed to providing cancer treatments of the future to the world of today.

TRIO’s head office is in Edmonton, Alberta with operations all throughout Canada, the USA, France and Uruguay. TRIO is looking for a Study Manager to join the Project Management team.

Study Manager Position Overview:

This position reports to:

• Senior Study Manager (SSM),

• Global Project Coordinator (GPC)

• or Study Manager (SM) with a Study Lead role

  This position supervises: None

Key relationships are maintained with: All departments

Responsibilities:

This position is responsible for performing any/all of the following tasks and responsibilities, as

well as any other tasks deemed appropriate by the Supervisor:

• Reviews and approves monitoring reports and ensures that any detected issue (Protocol Deviation or non-Protocol Deviation) is reported in the Clinical Trial Management System and is adequately followed until closure.

• Supports sites and CRAs on any questions they may have during the course of the trial.

• Oversees activities conducted by Third Party Organizations (TPOs), as applicable, and organizes regular teleconferences with these TPOs in order to follow-up on the activities they perform.

• Prepares, submits/oversees the submission of the documents requiring Ethics Committee approval (e.g. amended protocol/Informed Consent Form or other patients’ documents, Investigator Brochure).

• Participates in the development/review of trial operational documents, as well as global communications to sites/CRAs.

• Prepares and/or reviews training material for the CRAs on the trial/global calls with all CRAs and performs presentations.

• Performs Quality Controls (QCs) on the country/site files and works with the Administrative Project Coordinator(s) until the resolution of any issue detected during these QCs.

• Negotiates amendments to financial agreements with investigators/sites as per trial requirements.

• Reviews and approves invoices and supports finance with site fee reconciliation.

• Replies to findings of audits from sites he/she is responsible for and may act as an audit coordinator with other TRIO departments involved in order to consolidate answers to the audit reports.

• Participates in the revision of procedures involving the PM Department.

  Qualifications:

• Bachelor’s degree as a minimum, scientific background (Nurse, Scientist, Pharmacist, M.D.).

• At least, 1 year of experience in monitoring or coordination of clinical projects.

• Excellent English level, both orally and in written.

• Good communication skills, both in written and oral.

• Excellent knowledge of ICH/GCP.

  What TRIO Can Offer You:

• Competitive salary

• Paid time off 

• Flexible working hours 

  Integrity • Teamwork • Passion

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