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. /p pJoining 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. /p h3Why Pivotal: /h3 ul liWe are passionate and fully committed to medical science while using technology, to make a positive impact. /li liWe 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. /li liWe 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 h3Your responsibilities will include: /h3 h3SCTA Clinical Operations /h3 ul liAct as a central contact for the team for assigned project communications, correspondence and associated documentation. /li liStart-up activities: feasibilities under direction of Project Director (PD), Project Manager (PM)



and or Lead CRA, obtain site contact information, essential documents, etc. /li liInitiate, maintain and reconcile e-TMF, In-House TMF ISF /li liOrganize study information on shared file drives. /li liOrganize and maintain tracking systems and tools to support the conduct of a clinical study from start-up to close-out. /li liPerform document editing, adaptation, correction and format as needed. /li liControl and tracking of biological patient samples from sites to central labs. /li liAct 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. /li liUnder 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. /li liSupport with travel management (BTU) and reception tasks if required. /li liPerform other related duties relevant to the work described herein. /li /ul h3eTMF Specialist /h3 ul liProcesses study documents which may include but are not limited to document receipt, scanning, quality control, naming, upload and filing.



/li liAssists in periodic quality controls of the eTMF in compliance with study specific TMF plans. /li liEnsures continuous audit/inspection readiness and completeness of the eTMF. /li /ul h3SCTA General office and meeting logistics /h3 pPrepare 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 pMentor, train and coordinate other CTAs and/or CTA Trainees /p h3Required profile: /h3 ul liHigh School certificate. /li liExperience in administrative area at CRO or a Pharmaceutical Company for a minimum of 5 years is desirable. /li liHigh knowledge of GCPs/ICH and local/international regulations is desirable. /li liOrganizational and planning skills. /li liIntermediate or high level of spoken and written English. /li liGood knowledge of current PC-applications. /li liHighly committed and ability to work under pressure. /li liTeam player and very good communications skills. /li liEmpathy and ability to establish good relationships with others. /li /ul h3What You Can Expect: /h3 ul liCareer growth resources and versátil work schedules. /li liTraining to enhance therapeutic knowledge. /li liExposure to dynamic work environments and new experiences /li /ul h3Commitment to Equal Opportunity: /h3 pAt 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 /p #J-18808-Ljbffr

📌 Senior Clinical Trial Assistant (Madrid)
🏢 Pivotal
📍 Madrid