Here at Syneos Health Portugal, we are looking for a Clin Ops Specialist (CTA) to be sponsor dedicated to a top 10 Pharma. The contract will be on a 6 months fixed term basis based at the sponsor's site in Portugal.
Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most.
The position is responsible for providing clerical, administrative, and technical administrative support to one or more business units or clients within Clinical Operations.
· Responsible for performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions;
· Assists Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on assigned studies, and communicating with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines;
· Creates and assists with maintenance of Trial Master File (TMF) and project files, including participation in file audits;
· Prepares and maintains site manuals, reference tools and other documents;
· Maintains, updates, and inputs clinical tracking information into databases;
· Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client;
· Manages shared mailbox, processes site requests and routes correspondence appropriately;
· Coordinates the ordering, packaging, shipping and tracking of site supplies and materials;
· Assists with coordination of team meetings, attends meetings and prepares accurate meeting minutes and action items;
· May handle receipt, tracking and disposition of Case Report Forms and Queries;
· Maintains overall awareness in the field of clinical research by completing all necessary and assigned training.
· High School diploma or equivalent;
· Good communication and interpersonal skills;
· Fluency in English and Portuguese;
· Ability to embrace new technologies.
We have a comprehensive benefits package and offer highly competitive remuneration.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.