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Clinical Study Site Management Specialist
Il y a 2 mois
At Advanced Clinical, we are seeking a highly skilled Clinical Study Site Management Specialist to join our team. As a key member of our site management team, you will be responsible for conducting end-to-end site start-up activities, serving as the primary point of contact for the site and the study team.
Key Responsibilities:- Support site level feasibility assessments, coordinate site identification at a country and regional level, and support site qualification and start-up activities.
- Conduct feasibility activities, including the negotiation and collection of Confidential Disclosure Agreements and the collection and analysis of Feasibility Questionnaires.
- Collect essential documents, track, review quality, and upload into systems.
- Support the collection of country and site level intelligence and complete Ethics Committee and Regulatory Authority submissions.
- Bring sites to Regulatory GreenLight and ensure site fulfillment of all maintenance activities.
- BA/BS degree in Science or related field.
- At least 5 years' experience in site start-up and contract management in pharmaceutical company or in clinical research organization.
- Thorough knowledge of applicable regulations, drug development, and clinical trial management procedures.
- Strong presentation, documentation, and interpersonal skills.
- Proficient in MS Office, MS Project, email, and Internet.
We are looking for a goal-oriented, self-starter with proven ability to work independently and manage multiple tasks simultaneously. If you have a thorough understanding of country level cultural norms and local healthcare systems, and are able to initiate and develop relationships with local investigators and key site personnel, we encourage you to apply.
