Clinical Trial Regulatory Manager

2 weeks ago


Cape Town, South Africa TREAD Research (PTY) LTD Full time

Clinical Trial Regulatory Manager with at least 2 years of experience.

Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for complex projects and programs.

RESPONSIBILITIES
- Acts as a Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects or programs and may act as a Regulatory Oversight for a key customer
- Ability to administratively and technically/scientifically review core scientific documentation and feedback gap analysis to customers.
- May strategically plan and perform European centralized submissions and facilitate global country submissions on complex studies or programs
- May provide support on key regulatory business development opportunities and complete Data Informed Protocol Assessments (DIPAs)
- Understands the Scope of Work, deliverables and budget for any given project and ensure timelines are met.
- Ensures accurate completion, maintenance and adherence to internal systems, databases, tracking tools and project plans in line with agreed SOPs
- Deliver regulatory training/presentations as required, internally or externally
- May mentor junior colleagues and engage in department knowledge sharing
- May perform additional tasks as deemed appropriate by Line Manager

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Good understanding of the regulations, directives and guidance supporting clinical Research and Development
- Demonstrates comprehensive regulatory/technical expertise
- Good negotiating skills and the ability to identify and resolve issues, using flexible adaptable approach
- Strong ownership and oversight skills
- Demonstrated skills in chairing meetings and working on initiatives
- Ability to work on several projects, retaining quality and timelines and can prioritize workload
- Ability to propose revisions to SOPs or suggest process improvements for consideration
- Strong mentoring skills, helping junior colleagues and setting a positive example
- Innovative and solutions-driven
- Strong skills in establishing and maintaining effective working relationships with co-workers, managers and clients

Looking to appoint 15 March 2024

**Job Types**: Full-time, Permanent

Ability to Commute:

- Cape Town, Western Cape (preferred)

Ability to Relocate:

- Cape Town, Western Cape: Relocate before starting work (preferred)

Application Deadline: 2024/03/04
Expected Start Date: 2024/03/15



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