Site Activation and Maintenance Expert
3 days ago
We are seeking a highly skilled Regulatory and Start Up Manager to join our team at IQVIA, where we are pushing the boundaries of human science and data science to make a significant impact in the life sciences industry.
The successful candidate will be responsible for directing and managing the delivery of all required site activation, maintenance, and regulatory activities for selected studies or multi-protocol programs. This includes overseeing pre-award activities, ensuring compliance with project timelines, and collaborating across departments to successfully deliver the agreed project scope.
Key Responsibilities:
- Oversee the execution of site activation, including pre-award/bid defense activities, and maintenance for assigned projects in accordance with the agreed RSU site activation strategy.
- Develop, implement, and maintain management plans according to the scope of work and project plan, ensuring alignment with project strategy.
- Collaborate with cross-functional teams to facilitate efficient business development, initiation, and maintenance of clinical trials.
- Evaluate and mitigate regulatory risks, ensuring compliance with applicable guidelines and regulations.
- Determine regulatory strategy and expectations for submissions and authorizations.
- Identify and address regulatory complexities and challenges, offering creative solutions to support bid processes and site activation plans.
- Manage the execution of operational strategies for maintenance of clinical study approvals, authorizations, and review/negotiation of contracts and essential documents.
- Mentor and coach colleagues as required, ensuring accurate completion and maintenance of internal systems.
Qualifications:
- 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 and influence stakeholders
- Excellent interpersonal skills and strong team player
- Proven ability to work through others to deliver results on complex projects
- Thorough understanding of regulated clinical trial environments and drug development processes
- Demonstrated proficiency in using systems and technology to achieve work objectives
- Good regulatory and 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
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