Clinical Research Associate monitoring Canadian clinical trials for Parexel, a global clinical research organization. Managing site relationships, compliance, data quality, and study delivery.
About the role
- Senior Clinical Scientist authoring clinical and regulatory documents for Indero, a global dermatology and rheumatology CRO. Supporting study design, data interpretation, submissions, and scientific teams.
Responsibilities
- Author and contribute to clinical and regulatory documents, including study protocols, statistical analysis plans, clinical study reports, narratives, abstracts, posters, and manuscripts
- Contribute to study design and review informed consent forms
- Review statistical analysis plans and tables, figures, and listings
- Review, analyze, and interpret study data
- Perform online literature searches
- Prepare and review training materials for scientific teams and the company
- Manage medical writing deliverables, stakeholder communication, project issues, and timelines
- Provide scientific, therapeutic, and medical writing expertise during study conduct
- Mentor and train new and junior staff
- Perform quality-control reviews of documents prepared by team members
- Support delivery of scientific affairs commitments on time, within budget, and in compliance with SOPs and regulations
- Contribute to organizational improvements and implementation of new processes and procedures
- Participate in QA or client audits as a scientific subject-matter expert
- Support business development with proposal synopses, bid-defense content, sponsor meetings, and sponsor questions
- Review scientific-affairs assumptions and budgets during RFPs
- Provide scientific support and medical writing for pre-IND and IND submissions
- Provide scientific expertise and potentially lead cross-functional projects
- Perform other assigned responsibilities when qualified and trained
Requirements
- MSc in a related field of study or combination of relevant education and work experience
- Minimum of 6 years of clinical research experience
- 3 years in writing clinical/regulatory documents and analyzing and reporting study data in CRO/pharmaceutical industry
- In-depth knowledge of drug development process and applicable regulatory requirements
- Strong English communication skills
- Advanced English writing skills
- Strong proficiency in Word, Excel, and PowerPoint, with advanced skills formatting large documents
- Ability to handle varied and multiple tasks and prioritize workload
- Excellent attention to detail
- Client-focused attitude
- Excellent interpersonal skills and teamwork
- Quick learner, adaptable, and versatile
- Leadership and ability to positively influence others
- Good knowledge of Good Clinical Practices and applicable Health Canada and FDA regulations/guidelines
- Must be legally authorized to work in Canada
Benefits
- Permanent full-time position
- Flexible schedule
- Vacation
- Home-based position
- Ongoing learning and development
- Medical, dental, and vision insurance
- Retirement plan
- Personal days
- Virtual medical clinic
- Public transit discounts
- Social activities
- Attractive advancement opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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