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As a Regulatory and Start Up Manager at IQVIA, you will play a critical role in the delivery of site activation, maintenance, and regulatory activities for selected studies or multi-protocol programs. Your expertise will be essential in overseeing the scope of work, budget, and resources to ensure successful project outcomes.
Key Responsibilities- Develop and implement site activation strategies in accordance with project timelines and regulatory requirements.
- Collaborate with cross-functional teams to ensure seamless execution of site activation and maintenance activities.
- Provide regulatory and technical scientific support to facilitate efficient business development, initiation, and maintenance of clinical trials.
- Contribute to the development of technical and administrative documentation to support business development and study initiation.
- Lead the development of regulatory strategies and expectations for submissions and authorizations.
- Identify and mitigate regulatory complexity and challenges to support the bid process and site activation plan.
- Assess and review the regulatory landscape to provide accurate regulatory intelligence to support assigned studies and the company.
- Execute operational strategy and expectations for maintenance of clinical study approvals, authorizations, and contracts.
- Ensure quality standards are met through collaboration with Quality Management.
- Mentor and coach colleagues as required.
- Bachelor's Degree in Life Sciences or related field.
- 7 years' relevant experience in a scientific or clinical environment, including international roles.
- Strong negotiation and communication skills with ability to challenge.
- Proven ability to work through others to deliver results to quality and timeline metrics on complex projects.
- Thorough understanding of regulated clinical trial environment and in-depth knowledge of drug development process.
- 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.
- Good leadership skills, with ability to motivate, coach, and mentor.
- Good organizational and planning skills.
- Ability to exercise independent judgment taking calculated risks when making decisions.
- Proven ability to establish and maintain effective working relationships with co-workers, managers, and sponsors.
- Excellent understanding of study financial management.
- Proven ability to work on multiple projects balancing competing priorities.