Senior Site Activation & Regulatory Specialist

Regulatory Jobs; Durham (NC); Vor Ort; USD 48.000 - 123.000; Vollzeit

Zusammenfassung

IQVIA is a leading global provider of clinical research services. This role focuses on site activation at country level, ensuring regulatory and contractual document adherence, and coordinating with SAM, PM teams, and sponsors.

Ideal candidates bring life sciences education, clinical research experience, and strong communication skills to manage timelines and maintain regulatory compliance across sites and systems.

Qualifikationen

• Bachelor's Degree in life sciences or a related field; 3 years’ clinical research or related experience.
• 3 years clinical research experience, including 1 year in a leadership capacity.
• In-depth knowledge of clinical systems, procedures, and corporate standards.
• Good negotiating and communication skills with ability to challenge, if applicable.
• Effective communication, organizational, and interpersonal skills.
• Ability to work independently and to effectively prioritize tasks.
• Ability to manage multiple projects.
• Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
• Knowledge of applicable regulatory requirements, including local regulations, SOPs and company’s Corporate Standards.
• Understanding of regulated clinical trial environment and knowledge of drug development process.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Aufgaben

• Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
• Perform start up and site activation activities according to applicable regulations, SOPs and work instructions.
• Prepare site regulatory documents, reviewing for completeness and accuracy.
• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
• Review and provide feedback to management on site performance metrics.
• Review, establish and agree on project planning and project timelines.
• Inform team members of completion of regulatory and contractual documents for individual sites.
• Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
• Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
• Perform quality control of documents provided by sites.
• May have direct contact with sponsors on specific initiatives.

Kenntnisse

GCP/ICH knowledge

Regulatory knowledge

Leadership experience

Communication skills

Negotiation skills

Ausbildung

Bachelor's Degree in life sciences

Tools

Clinical systems

Jobbeschreibung

IQVIA is a leading global provider of clinical research services. This role focuses on site activation at country level, ensuring regulatory and contractual document adherence, and coordinating with SAM, PM teams, and sponsors.

Ideal candidates bring life sciences education, clinical research experience, and strong communication skills to manage timelines and maintain regulatory compliance across sites and systems.