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Company | Fortrea |
Address | Montreal, Quebec, Canada |
Employment type | FULL_TIME |
Salary | |
Category | Hospitals and Health Care |
Expires | 2023-10-29 |
Posted at | 7 months ago |
Start-up Associate Manager/COM-R
- Responsible for clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management.
- Work with staff in Operational Strategy & Planning, Business Development and Operations, to provide feasibility data and other relevant data critical to the ability of the organization to develop evidence-based plans for the successful implementation and conduct of global clinical trials.
- Ensure country deliverables, timelines and results for assigned protocols are met to meet country commitments.
- Collaborates closely with Regional Operations to align country timelines for assigned protocols. Provides support and oversight to local vendors as applicable.
- Manage and track clinical research-related payments - Payment reconciliation at study close-out.
- University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology.
- Thorough understanding of the drug development process
- Interact with internal and external customers with high degree of professionalism and discretion.
- Excellent communication skills, oral and written along with good organizational and time management skills.
- Experience interacting with IRB/IEC and Regulatory Authority for assigned protocols.
- Ability to lead and develop junior staff.
- Detail and process oriented
- Working knowledge of ICH, FDA, local regulatory requirements, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project team and investigative sites preferred.
- Fluent in local office language and in English, both written and verbal.
- Flexible and adaptable to a developing work environment
- Self-motivation with the ability to work under pressure to meet deadlines.
- Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
- Multi-tasking capability.
- Positive attitude and approach
- 5 or more years of experience in clinical research
- Works well independently as well as in a team environment.
- Experience negotiating and developing local language materials including local language Informed Consents and translations.
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