
Clinical Trial Site Activation Specialist
8 hours ago
Job Overview:
Serve as a pivotal point of contact for investigative sites, overseeing study feasibility, site identification, project leadership and GICS. Ensure adherence to standard operating procedures (SOPs), work instructions (WIs) and project timelines.
Perform regulatory, start-up and maintenance activities in line with applicable regulations, SOPs and work instructions.
Prepare site regulatory documents, reviewing them for completeness and accuracy.
Review, prepare and negotiate site contracts with sites, ensuring clarity and fairness.
Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
Ensure contracts are fully executed, regulatory documents and approvals are granted, IP Release authorized and specific project deliverables are completed.
Review and provide feedback on site performance metrics to management.
Establish and agree on project planning and project timelines, ensuring overall project efficiency and adherence to project deadlines.
Contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies.
Assist in pre-award activities including bid defenses, proposals and oversight of scope of work at country level.
Participate in feasibility and/or site identification activities, providing expertise and guidance.
Key Responsibilities:
Bachelor's Degree in life sciences or related field required, along with 3 years' clinical research experience; or equivalent combination of education, training and experience.
Strong knowledge of clinical systems, procedures and corporate standards essential.
Excellent negotiation, communication and interpersonal skills required.
Effective organizational, time management and problem-solving skills necessary.
Ability to work independently and prioritize tasks effectively.
Familiarity with GCP/ICH and applicable regulatory guidelines.
Understanding of regulated clinical trial environment and drug development process.
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
About Us:
We are a global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We aim to improve patient outcomes and population health worldwide by accelerating the development and commercialization of innovative medical treatments. Learn more at our website.
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