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
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.
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.
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!
- Clinical point of contact for scientific issues/questions for internal and external stakeholders.
- Lead contributor to the clinical sections of regulatory documents including study protocol, investigator’s brochure, Quality Overall Summary (QOS), safety update reports, clinical overview/summaries.
- Provides scientific input to Study Manager for data management activities (e.g., EDC, CRFs).
- Collaboratively plans CSRs with medical writing and biostatistics.
- Works with Biostatisticians on design of clinical studies and analysis of data, and with medical lead to ensure medical input/oversight of study design and medical review of data during clinical trials and analysis.
- Supports publications/presentations as needed.
- Reconciles and review all protocol deviation classifications.
- Assesses and prepares protocol deviation list for CSR.
- Collaborates with medical writing to develop trial results communication for investigators.
- Provides clinical specifications to SM to support interactions with external vendors.
EDUCATION, EXPERIENCE & SKILLS: EDUCATION:
- Qualified candidates will have an advanced degree in Life Sciences (eg, Ph.D. or Pharm.D.) or Medicine.
- Or, qualified candidates will have a Master’s degree in Life Sciences with significant (7+ years) pharmaceutical and related research experience.
- 7+ years of experience with a pharmaceutical company, CRO or of related experience.
- Must have knowledge and understanding of Health Canada, FDA and ICH regulatory requirements and procedures applicable to Clinical Research and Product Development.
- At least 4 years of experience in clinical trials with direct experience in designing and managing high quality clinical studies.
- Previous experience working in a matrix environment is highly desirable. Experience in clinical operations, biostatistics or data management is an asset.
KNOWLEDGE, SKILLS & ABILITIES:
- Ability to drive efforts, overcome obstacles and achieves results within budget and timeline specifications.
- Excellent organizational, analytical, leadership, problem solving and interaction skills.
- Ability to work in a highly diverse and fast paced, team environment.
- Excellent written/verbal communication and interpersonal skills as well as excellent computer skills required.
Job Type: Full-time
- Dental care
- Disability insurance
- Extended health care
- Life insurance
- Vision care
Flexible Language Requirement:
- French not required
- 8 hour shift
Work Location: Hybrid remote in Toronto, ON