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Study Manager

3 weeks ago

Edmonton, Canada Translational Research in Oncology Full time

If you are an experienced Study Manager who is passionate about oncology research and looking to join a highly skilled and knowledgeable team, TRIO is the place for you

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 is looking for a **Study Manager **to join our **Project Management **team reporting to the **Senior Study Manager** or **Global Project Coordinator**. This position will be home-based, office-based or hybrid-based depending on which city the successful applicant lives in.

**Responsibilities**:
Reporting to the Senior Study Manager or Global Project Coordinator, the Study Manager will be responsible for the below:

- 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 resolution of any issue detected during these QCs.
- Negotiates amendments to financial agreements with investigators/sites as per trial requirements.
- Reviews and approves invoices, supports finance with site fee reconciliation.
- Replies to findings of audits from sites he/she is responsible 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, Skills and Experience**:

- Bachelor's degree as a minimum, scientific background (Nurse, Scientist, Pharmacist, M.D.).
- At least 18 months of experience at TRIO is required.
- Excellent English level, both orally and written.
- Good communication skills, both in written and oral.
- Excellent knowledge of ICH/GCP.

**What TRIO Can Offer You**:

- Competitive salary
- Vacation and benefits to be discussed during recruitment process
- Flexible working hours
- Monthly internet allowance

**Health & Safety**:
**Integrity - Teamwork - Passion**

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