Role OverviewDirect and manage the delivery of all required site activation, maintenance, and regulatory activities for selected studies or multi-protocol programs. Oversee the execution of Site Activation and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines.
What You Will Do
Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation, and maintenance of clinical trials. Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations.
Why It Might Be a Fit
The ideal candidate will have strong negotiation and communication skills, excellent interpersonal skills, and a thorough understanding of the regulated clinical trial environment and the drug development process.
Requirements
- Bachelor's Degree in Life sciences or related field
- 7 years' relevant experience in a scientific or clinical environment
- Strong negotiation and communication skills
- Excellent interpersonal skills
- Proven ability to work through others to deliver results
- Thorough understanding of regulated clinical trial environment
- In-depth knowledge of drug development process
- Demonstrated proficiency in using systems and technology
- Good regulatory and/or technical writing skills
- Strong knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Good leadership skills
- Good organizational and planning skills
- Ability to exercise independent judgment
- Good presentation skills
- Proven ability to establish and maintain effective working relationships
Benefits
- Potential base pay range of $74,600.00 - $216,000.00
- Incentive plans, bonuses, and/or other forms of compensation
- Range of health and welfare and/or other benefits
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