Senior Clinical Scientist

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🔥 1 hour ago

🇨🇦 Canada – Remote

⏰ Full Time

đźź  Senior

đź§Ş Clinical Research

đź‘» Ghost score 12%

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Logo of Innovaderm Research Inc.

Innovaderm Research Inc.

201 - 500 employees

đź’Š Pharmaceuticals

🏥 Healthcare

đź’Ľ Consulting

Pharmaceuticals • Healthcare • Consulting

Innovaderm Research Inc. is a Contract Research Organization (CRO) specialized in dermatology, providing scientific guidance and conducting Phase I to IV clinical trials in the field. With a strong presence in North America and Europe, Innovaderm offers a comprehensive range of services including study design, regulatory consulting, project management, patient recruitment, and data management, ensuring high-quality research outcomes and customer satisfaction since 2000.

đź“‹ Description

• 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

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