Project Manager, Early Phase and Translational Research
New
Anywhere in CanadaFull-TimeManager
Salary not disclosed
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Job Details
- Languages
- English, French
- Experience
- Minimum 3 years of relevant industry experience; At least 2 years experience coordinating activities related clinical trial management
- Required Skills
- GCPMicrosoft Office
Requirements
- B.Sc. in a related field of study to clinical research
- Minimum 3 years of relevant industry experience in the pharmaceutical, biotechnology or CRO industry
- At least 2 years experience coordinating activities related clinical trial management
- Experience in early phase is considered a strong asset
- Excellent knowledge of GCP and ICH standards, FDA and Canadian regulations
- Excellent knowledge of Microsoft Office suite
- Excellent oral and written skills in English, French is an asset
- Excellent communication skills
- Ability to work in a team environment and establish good relationships with colleagues and sponsors
- Strong sense of creativity and process improvement
- Excellent judgement and good problem-solving abilities
- Strong ability to carry out different projects and work under pressure while meeting timelines
- Detailed oriented and excellent documentation skills
- Quick learner, good adaptability and versatile
- Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines
Responsibilities
- Ensure successful initiation, planning, execution, monitoring, controlling and closure of assigned Early Phase clinical research projects.
- Responsible for the operational management and oversight of clinical investigative sites and clinical monitoring deliverables.
- Ensure compliance with the study budget, project scope and timelines and in accordance with applicable standard operating procedures (SOPs), good clinical practices, regulatory and study-specific requirements.
- May serve as primary contact for the Sponsor, sites, CRAs, vendors and internal team throughout the study.
- Coordinate tasks and deadlines between the different departments involved in the project.
- Oversee project coordinators, SSU team members, RDA and RAC resources to ensure correct prioritization of site activation activities.
- Interact with vendor management to ensure vendor supplies and services are coordinated with site activation timelines.
- Assist with managing the needs and expectations of the Sponsor and other internal and external project stakeholders.
- Manage the quality of assigned work and deliverables.
- Assist with providing project status updates to external and internal stakeholders.
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