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Senior Site Management Specialist
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The ideal candidate for this role will possess excellent communication skills, with the ability to work effectively with sites and colleagues. This individual must be highly organized, with a strong attention to detail, and be able to manage multiple priorities in a fast-paced environment.
">This role will involve performing site monitoring visits to ensure that sites are conducting studies and reporting data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. The successful candidate will be responsible for:
">- Performing site monitoring visits (selection, initiation, monitoring, and close-out visits) in accordance with contracted scope of work and regulatory requirements.">
- Working with sites to adapt, drive, and track subject recruitment plans to enhance predictability.">
- Administering protocol and related study training to assigned sites and establishing regular lines of communication with sites to manage ongoing project expectations and issues.">
- Evaluating the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.">
- Escalating quality issues as appropriate.">
- Managing the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form completion and submission, and data query generation and resolution.">
- Sure that copies or originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.">
- Creating and maintaining appropriate documentation regarding site management, monitoring visit findings, and action plans by submitting regular visit reports, generating follow-up letters, and other required study documentation.">
- Collaborating and liaising with study team members for project execution support as appropriate.">
We are seeking an experienced professional with the following qualifications:
">- A Bachelor's Degree in a scientific discipline or health care preferred.">
- An excellent command of English (written/spoken).">
- A basic knowledge of and skill in applying applicable clinical research regulatory requirements.">
- Good therapeutic and protocol knowledge as provided in company training.">
- Strong attention to detail and excellent communication skills.">
- Exceptional problem-solving, judgment, and decision-making abilities.">
- Computer skills including proficiency in Microsoft Word, Excel, and PowerPoint.">
- Organizational and problem-solving skills.">
- Effective time and financial management skills.">
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.">
IQVIA offers a competitive salary and benefits package, providing opportunities for professional growth and development.
">As a member of our team, you will have access to cutting-edge technology, continuous learning and development opportunities, and a collaborative work environment that fosters innovation and creativity.
">Our company is committed to excellence and innovation, seeking talented individuals who share our vision and values.
">Join us and contribute to shaping the future of our organization, making a positive impact on patient outcomes and population health worldwide.
">Others:">At IQVIA, we value diversity and inclusion, creating connections that accelerate the development and commercialization of innovative medical treatments.
">We seek out diverse talent with curious minds and a relentless commitment to innovation and impact.
">Thank you for your interest in growing your career with us.
