Descripción de la oferta
p Senior Clinical Trial Assistant /p p Pivotal is excited to expand our team and we are looking for an experienced, highly motivated b Senior /b b Clinical Trial Assistant /b who shares our vision of providing clinical research excellence. /p p Joining Pivotal as a b Senior /b b Clinical Trial Assistant /b means that you will enjoy being a member of one of the leading full-service contract research organizations in Europe with a very solid reputation. This role promises to gain direct experience with our clients and offer career growth and professional development within a scientific and data driven company. You’ll have the opportunity to put your passion into working in an environment designed to help you gain experience in a wide variety of therapeutic areas. /p pb Why Pivotal: /b /p ulli We are passionate and fully committed to medical science while using technology, to make a positive impact. /lili We provide an exceptional experience. We take care of our employees, and we ensure everyone receives permanent mentoring and training and a push to always take one step further as well as untold international experience that will help you grow and will accompany all your life. /lili We are continuously building the company, bringing together diversity of thoughts, backgrounds, cultures, and perspectives, being able to create a place where everyone feels like they belong. /li /ul pb Your responsibilities will include: /b /p pu SCTA Clinical Operations /u /pulli Act as a central contact for the team for assigned project communications, correspondence and associated documentation. /lili Start-up activities: feasibilities under direction of Project Director (PD), Project Manager (PM) and or Lead CRA, obtain site contact information, essential documents, etc. /lili Initiate, maintain and reconcile e-TMF, In-House TMF ISF /lili Organize study information on shared file drives. /lili Organize and maintain tracking systems and tools to support the conduct of a clinical study from start-up to close-out. /lili Perform document editing, adaptation, correction and format as needed. /lili Control and tracking of biological patient samples from sites to central labs. /lili Act as liaison for third party vendors and management of vendor invoices under PD, PM and or Lead CRA supervision and provide detailed Request for Proposals (RFPs) tailored to specialized vendors. /lili Under the direction of PD, PM and or Lead CRA organize and coordinate the logistics of internal and external meetings such as CRA/ Investigator Meetings, etc. /lili Support with travel management (BTU) and reception tasks if required. /lili Perform other related duties relevant to the work described herein. /li /ul pu eTMF Specialist /u /pulli Processes study documents which may include but are not limited to document receipt, scanning, quality control, naming, upload and filing. /lili Assists in periodic quality controls of the eTMF in compliance with study specific TMF plans. /lili Ensures continuous audit/inspection readiness and completeness of the eTMF. /li /ul pu SCTA General office and meeting logistics /u /pp Prepare the meeting logistics as dictated by Office Management (preparation of the meeting room, serve the catering, preparation of the morning coffee for all employees, etc.) /p pu Managerial duties /u /pp Mentor, train and coordinate other CTAs and/or CTA Trainees /p pb Required profile: /b /p ulli High School certificate. /lili Experience in administrative area at CRO or a Pharmaceutical Company for a minimum of 5 years is desirable. /lili High knowledge of GCPs/ICH and local/international regulations is desirable. /lili Organizational and planning skills. /lili Intermediate or high level of spoken and written English. /lili Good knowledge of current PC-applications. /lili Highly committed and ability to work under pressure. /lili Team player and very good communications skills. /lili Empathy and ability to establish good relationships with others. /li /ul pb What You Can Expect: /b /p ulli Career growth resources and flexible work schedules. /lili Training to enhance therapeutic knowledge. /lili Exposure to dynamic work environments and new experiences /li /ul pb Commitment to Equal Opportunity: /b /p p At Pivotal, we believe that diversity and inclusion are essential to the success of our team. We are committed to providing equal employment opportunities to all candidates, regardless of race, gender, sexual orientation, disability, or any other characteristic. /p
