Clinical Development Specialist
4 weeks ago
About Us
BioTalent Canada is a leading organization in the field of rare blood disorders, and we are seeking a highly skilled Clinical Development Specialist to join our team.
Job Summary
We are looking for an experienced Clinical Development Specialist to support the development and execution of clinical trials and studies related to rare blood disorders. The successful candidate will have a strong background in clinical research and experience working with pharmaceutical companies.
About the Role
The Clinical Development Specialist will be responsible for:
- Clinical Trial Management: Manage and coordinate clinical trials from initiation to completion, ensuring compliance with regulatory requirements and company standards.
- Study Site Identification and Recruitment: Identify and recruit potential study sites, conduct site visits, and ensure site feasibility.
- Data Management: Ensure accurate and timely data collection, entry, and analysis, as well as manage data discrepancies and resolve issues.
- Regulatory Affairs: Collaborate with cross-functional teams to prepare and submit regulatory documents, including investigator brochures, informed consent forms, and clinical trial applications.
Key Responsibilities
The Clinical Development Specialist will also be responsible for:
- Clinical Study Planning: Develop and execute clinical study plans, including study design, protocol development, and sample size calculations.
- Site Monitoring: Conduct regular site monitoring visits to ensure compliance with Good Clinical Practice (GCP) guidelines and study protocols.
- Data Quality Assurance: Ensure data quality by conducting regular audits and implementing corrective actions as needed.
Requirements
To be considered for this role, you must have:
- Advanced Degree: A degree in a life science or a related field, such as biology, chemistry, or pharmacy.
- Industry Experience: At least 2 years of experience in clinical research, preferably in a pharmaceutical company.
- Communication Skills: Excellent written and verbal communication skills, with the ability to effectively communicate complex information to various stakeholders.
Estimated Salary Range: $80,000 - $110,000 per year
What We Offer
BioTalent Canada offers a competitive salary, comprehensive benefits package, and opportunities for professional growth and development.
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