Project Specialist

hace 2 días

Madrid, España Syneos Health, Inc. A tiempo completo

Project Specialist / Sr Project Specialist (Sponsor Dedicated) UK, Spain, NL Project Specialist / Sr Project Specialist (Sponsor Dedicated) UK, Spain, NL We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. technical and therapeutic area training; 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. Keeps Project Leadership and Clinical Research Associates (CRAs) fully apprised of sites and study status. Provide administrative support to Project Leads and functional leads. Provide support for quality assurance activities, including preparation for audits and internal review, prepare documentation and follow through to resolution on actionable issues. High proficiency with full MS Office Applications. High level of competence in English language Further, nothing contained herein should be construed to create an employment contract. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Roles within Clinical Project Management job family areesponsible for planning, directing, creating and communicating clinical study time-lines. Ensures consistency of clinical study and processes across clinical trials, overseeing and resolving operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations such as site and vendor selection, preparing clinical trial budgets. Ensures studies are conducted within clinical trial protocols, monitoring progress and following up with team members and line managers when issues develop. The majority of time is spent in the delivery of support services or activities, typically under supervision. Roles do not typically require advanced education or training. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

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