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Syneos Health賽紐仕醫(yī)藥是一家全面整合生物制藥解決方案的公司，旨在幫助客戶加快推出新療法的速度。我們站在產(chǎn)品研發(fā)的角度，戰(zhàn)略性地融合臨床研發(fā)、醫(yī)學(xué)事務(wù)和商業(yè)能力，以及時應(yīng)對最新市場變化。 想了解更多關(guān)于我們?nèi)绾慰s短從實驗室到現(xiàn)實生活的距離，請訪問syneoshealth.com或訂閱我們的播客。

Job responsibilities

? Set-up, maintain and/or close out project files and study information ((e.g., regulatory documents, Trial Master File (TMF), enrollment, Adverse Events (AEs)/Serious Adverse Events (SAEs), site supplies, Institutional Review Board re-approvals, data queries) on a variety of databases and systems.
? Attends, participates, prepares and distributes meeting minutes and action items for both internal and external meetings (sponsor, trusted process, functional, investigator meetings). Follows up with team members on action items to closure.
? Maintains timely and effective communication among team members and site staff. Keeps Project Leadership and Clinical Research Associates (CRAs) fully appraised of sites and study status. May contact site staff as needed for critical information.
? Provide administrative support to Project Leads and functional leads.
? Ensure all study documents are archived based on the appropriate guidelines and policy.
? Provide support for quality assurance activities, including preparation for audits and internal review, prepare documentation and follow through to resolution on actionable issues.

Qualifications

What we’re looking for
? Associates Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field or equivalent combination of education and experience
? Knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.
? Strong organizational skills.
? Ability to manage time and work independently.
? High proficiency with full MS Office Applications.
? Strong communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
? Ability to travel if necessary preferred (approximately 5%)
? High level of competence in English language