PSenior Clinical Trial Assistant /ppbr/ppPivotal is excited to expand our team and we are looking for an experienced, highly motivated bSenior /b bClinical Trial Assistant /b who shares our vision of providing clinical research excellence. /ppbr/ppJoining Pivotal as a bSenior /b bClinical 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. /ppbr/ppbWhy Pivotal: /b /ppbr/pulliWe are passionate and fully committed to medical science while using technology, to make a positive impact. /liliWe 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. /liliWe 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 /ulpbr/ppbYour responsibilities will include: /b /ppbr/ppSCTA Clinical Operations /pulliAct as a central contact for the team for assigned project communications, correspondence and associated documentation. /liliStart-up activities: feasibilities under direction of Project Director (PD), Project Manager (PM) and or Lead CRA, obtain site contact information, essential documents, etc. /liliInitiate, maintain and reconcile e-TMF, In-House TMF ISF /liliOrganize study information on shared file drives. /liliOrganize and maintain tracking systems and tools to support the conduct of a clinical study from start-up to close-out. /liliPerform document editing, adaptation, correction and format as needed. /liliControl and tracking of biological patient samples from sites to central labs. /liliAct 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. /liliUnder 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. /liliSupport with travel management (BTU) and reception tasks if required. /liliPerform other related duties relevant to the work described herein. /li /ulpbr/ppeTMF Specialist /pulliProcesses study documents which may include but are not limited to document receipt, scanning, quality control, naming, upload and filing. /liliAssists in periodic quality controls of the eTMF in compliance with study specific TMF plans. /liliEnsures continuous audit/inspection readiness and completeness of the eTMF. /li /ulpbr/ppbr/ppbr/ppSCTA General office and meeting logistics /ppPrepare 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.) /ppbr/ppManagerial duties /ppMentor, train and coordinate other CTAs and/or CTA Trainees /ppbr/ppbRequired profile: /b /ppbr/pulliHigh School certificate. /liliExperience in administrative area at CRO or a Pharmaceutical Company for a minimum of 5 years is desirable. /liliHigh knowledge of GCPs/ICH and local/international regulations is desirable. /liliOrganizational and planning skills. /liliIntermediate or high level of spoken and written English. /liliGood knowledge of current PC-applications. /liliHighly committed and ability to work under pressure. /liliTeam player and very good communications skills. /liliEmpathy and ability to establish good relationships with others. /li /ulpbr/ppbWhat You Can Expect: /b /ppbr/pulliCareer growth resources and flexible work schedules. /liliTraining to enhance therapeutic knowledge. /liliExposure to dynamic work environments and new experiences /li /ulpbr/ppbCommitment to Equal Opportunity: /b /ppbr/ppAt 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