Introduction:
Welcome to dicentra!
We are a diverse team from a wide range of industries and backgrounds all united by one common passion: to improve the health and wellness of people around the world. Whether we are developing and executing a break-through clinical trial, issuing the required certifications to sell a product in a new country or jurisdiction, or guiding a client to help them successfully navigate through regulatory hurdles, we do it with confidence, knowing that our team is backed by incredible and wide-ranging experience and one of the highest success rates in the business. If you share our passion for improving health and wellness and want to find purpose in your work, apply now and join one of North America’s most respected brands in both the Health Sciences and Food industries.
Let’s build a better world, together!
Why join us
Best workplace
We nourish an environment devoted to honesty and fairness, trust and respect. We care deeply for our team members and take work-life balance seriously, allowing our people to decide on a schedule that best fits their life and working preferences.
Best people
We unite cross-industry professionals with a shared passion for improving people’s health and wellness. Our inspiring leaders are accessible and work eagerly side-by-side with individual employees to help them understand and achieve their objectives.
Best opportunities
We encourage our team members to continuously develop and enhance their skills and expertise. We recognize and reward courageous choices and innovative ideas that result in the growth of our people and company, and in the success of our clients.
Become a part of a purpose-driven and future-oriented business that impacts and improves millions of lives worldwide!
Responsibilities
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Acts as a clinical point of contact for scientific issues/questions for internal and external stakeholders.
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Being a lead contributor to the study design of clinical trials and analysis of data.
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Provides a scientific and medical review of data during the conduct of clinical trials and provides input during data analysis.
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Being a lead contributor to the clinical sections of regulatory documents including study protocol, investigator’s brochure, Quality Overall Summary (QOS), safety update reports, and clinical overview/summaries.
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Provides scientific input for data management activities (e.g. EDC, CRFs).
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Collaboratively plans CSRs with medical writing and biostatistics.
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Reconciles and reviews all protocol deviation classifications.
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Assesses and prepares protocol deviation list for CSR.
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Collaborates with medical writing to develop trial results communication for investigators.
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Supports publications/presentations as needed.
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Provides clinical specifications to SM to support interactions with external vendors.
Qualifications
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Advanced degree in Life Sciences (Ph.D. or Pharm.D.) or in Medicine (M.D.) and at least 4 years of experience in clinical trials with direct experience in designing and managing high-quality clinical studies,
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Master’s degree in Life Sciences (M.Sc.) with significant (7+ years) pharmaceutical and/or CRO research experience.
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Must have knowledge and understanding of Health Canada, FDA, and ICH regulatory requirements and procedures applicable to Clinical Research and Product/Device Development.
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Previous experience working in a matrix environment is highly desirable. Experience in clinical operations, biostatistics, or data management is an asset.
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Ability to drive efforts, overcome obstacles, and achieve results within budget and timeline specifications.
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Excellent organizational, analytical, leadership, problem-solving, and interaction skills.
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Ability to work in a highly diverse, fast-paced, and evolving team environment.
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Excellent written/verbal communication and interpersonal skills as well as excellent computer skills required.
In addition to the skills and qualifications above, we value the following qualities in all of our team members:
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Ability to work independently with little supervision or as a team.
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Willingness to take on challenges and learn in an ever-changing regulatory landscape.
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Proficiency in using MS Office applications.
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Strong attention to detail.
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Strong problem-solving skills.
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Strong verbal and written skills.
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Ability to manage and prioritize tasks in a fast pace, hard-deadline environment.
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Willingness to travel to client sites as needed.
Job Type: Full-time.
Location: Toronto, ON office.