Clinical Research Scientist

1 month ago

Toronto, Canada dicentra Inc. Full time

**Responsibilities**:

- Acts as a clinical point of contact for scientific issues/questions for internal and external stakeholders.
- Being a lead contributor to the study design of clinical trials and analysis of data.
- Provides a scientific and medical review of data during the conduct of clinical trials and provides input during data analysis.
- 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.
- Provides scientific input for data management activities (e.g. EDC, CRFs).
- Collaboratively plans CSRs with medical writing and biostatistics.
- Reconciles and reviews all protocol deviation classifications.
- Assesses and prepares protocol deviation list for CSR.
- Collaborates with medical writing to develop trial results communication for investigators.
- Supports publications/presentations as needed.
- Provides clinical specifications to SM to support interactions with external vendors.

**Education, Experience & Skills**:

- 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,

or
- Master’s degree in Life Sciences (M.Sc.) with significant (7+ years) pharmaceutical and/or CRO research experience.
- Must have knowledge and understanding of Health Canada, FDA, and ICH regulatory requirements and procedures applicable to Clinical Research and Product/Device Development.
- Previous experience working in a matrix environment is highly desirable. Experience in clinical operations, biostatistics, or data management is an asset.
- Ability to drive efforts, overcome obstacles, and achieve results within budget and timeline specifications.
- Excellent organizational, analytical, leadership, problem-solving, and interaction skills.
- Ability to work in a highly diverse, fast-paced, and evolving team environment.

Excellent written/verbal communication and interpersonal skills as well as excellent computer skills required.

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