Description
You will direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs.
Key responsibilities include:
- Overseeing site activation and maintenance for assigned projects, adhering to project timelines and strategies
- Developing, implementing and maintaining management plans according to the scope of work and project plan
- Ensuring collaboration across regulatory and site activation teams, and providing specialist regulatory and technical scientific support
- Providing guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phases
- Determining regulatory strategies and expectations, and assessing regulatory landscapes
- Executing operational strategies for maintenance of clinical study approvals and authorizations
- Mentoring and coaching colleagues as required
- Delivering presentations and training to clients, colleagues and professional bodies
You will need:
- A bachelor's degree in life sciences or a related field
- 7 years' relevant experience in a scientific or clinical environment, including demonstrable experience in an international role
- Strong negotiation and communication skills, with the ability to challenge
- Excellent interpersonal skills and the ability to work as a team player
- Proven ability to work through others to deliver results on complex projects
- Thorough understanding of the regulated clinical trial environment and in-depth knowledge of the drug development process
- Demonstrated proficiency in using systems and technology to achieve work objectives
- Good regulatory and/or technical writing skills
- Strong knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines
Benefits may include a range of health and welfare benefits, incentive plans, bonuses, and other forms of compensation.
The potential base pay range for this role, when annualized, is $74,600.00 - $216,000.00.