About this role
We’re hiring a Clinical Study Manager for our client, one of the biggest life science companies in the world, to support their clinical development team.
- Oversee performance of CROs, third party vendors, and field CRAs including monitoring, to ensure compliance with study protocol and in accordance with scope of work and in accordance with corporate timelines; identify areas of concern and escalate to CMO or CRO as appropriate;
- Develops the comprehensive overview and operational plans for the study;
- Assist in preparing Clinical Study Reports and annual safety reports;
- Accountable for the development of the Core Study Documents and processes including: Data collection tool, Study Monitoring Plan, Drug Forecasting and Medical Research Report;
- Track items related to CDAs, budget and contract completion status.
- Assurance of regulatory compliance of investigational sites with company SOPs, EMA/FDA and ICH guidelines.
- Identify, select, and monitor performance of investigational sites for clinical studies; prepare accurate and timely visit reports from all site interaction visits.
- 3 to 7 years experience as a Clinical Project Manager;
- Bachelor's degree or equivalent, in a biomedical, life science or related field of study;
- In depth knowledge of drug development and clinical trials (phase I to IV);
- Demonstrated leadership skills in leading, managing and motivating matrix teams
- Knowledge of study document processing and budget management procedures;
Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 42 countries. Advancing your career takes time and effort – let us match you to your ideal position.
Join the Brunel Family
Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 40 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.
Start applying immediately
Sending an application is quick and easy. Just make sure you have the required documents ready to go.
- Certifications (optional)
- Job references (optional)
- Motivation Letter (optional)
Any questions remaining?
Your consultant, Monnatha Grego is happy to clarify anything about this vacancy. When reaching out, use the pub number:
Brunel Canada - Calgary
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