CTMS System Specialist\nWe have current opportunities for a CTMS System Specialist in Europe! Join our growing team.\nPrecision for Medicine is a precision medicine CRO. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.\nWe offer flexible location options, and remote based working.  This position can be based in one of the following countries: UK, France, Spain, Italy, Germany, Belgium, Netherlands, Poland, Hungary, Serbia. Romania, Slovakia. \nPosition Summary:\nWe are seeking a responsible, dynamic, creative and highly motivated CTMS System Specialist to join our Clinical Operations Department. This full-time position will serve as a subject matter expert over CTMS, supports the Clinical Study team in the set-up and configuration of the system, as well as ongoing maintenance of the system for studies lifecycle. This position will collaborate with Clinical Systems Manager and IT to define and deliver solutions that successfully meet the above objectives. This position will collaborate with Clinical Systems leadership and IT to define and deliver solutions that successfully meet the above objectives. Responsible for combining clinical operations and technology skills with excellent independent work ethic, communication, facilitation, and presentation skills. Provides technical guidance and support with respect to the CTMS and other systems. \n \nEssential functions of the job include but are not limited to:\n\nProvide advanced System Administrator management of Precision’s Clinical Trial Systems, serving as main subject matter expert (SME) for the CTMS and eTMF system.\n\nAssist with new version releases and configuration changes, including development, testing, and validation oversight or as needed User Acceptance Test (UAT) execution.\n\nCollaborate with study team leads to lead the set-up of studies, study teams and sites in the CTMS ensuring programs are configured according to the specific study requirements including: countries and sites; grant access for internal, sponsor and 3rd party vendor users; baseline expected deviation categories, study/visit plans, visit report & letter templates and baseline milestones\n\nWork with data management and clinical programming to establish potential for integration with EDC.\n\nManage end-user and group permission settings.\n\nProvide adequate training of system functionality to study teams, including external partners, sponsor and/or site staff, to ensure that study teams have the guidance needed to work CTMS features independently and meet periodically with study teams to offer ongoing support.\n\nCreate and/or provide input for the creation of work instructions/job aids, assess global & project specific trip report & letter templates, assist teams with workflows and provide training materials/tools as needed.\n\nContinually assess that CTMS features are functioning properly and efficiently; track all issues & observations for future enhancement, bug fixes, or ongoing needs for training of CTMS features for continuous improvement of the management of the system.\n\nIntegrate CTMS activities in line with integrations with the corresponding eTMF as necessary.\n\nClinical Trial Management duties (as needed):\n\n\nCreate and manage study timelines and milestones.\n\nAssist with the site status.\n\nAssess subject enrollment, status, visit dates, procedures, etc.\n\nEntry of monitoring visits, study activities, deviations, assist with trip report workflows, develop activity plans, etc.\n\nMonitor completeness and quality of the CTMS (from start up to final deliverable). \n\nPerform periodic reviews to ensure CTMS adoption and progress is timely and in line with the current stage of each program.\n\n\n\n\n\nQualifications:\nMinimum Required:\n\nBachelor’s Degree preferred.\n\n4+ years of Clinical Systems team experience within a CRO is highly preferred.\n\n\n\nOther Required:\n\n2+ years CTMS or other clinical program management system(s) experience\n\nWorking knowledge of ICH-GCP guidelines and major Health Authority regulations as they pertain to the operational aspects of clinical studies and the management of TMF content.\n\nExcellent planning, organizational and time management skills, including the ability to support and prioritize multiple projects.\n\nExtensive knowledge of monitoring and site management; some knowledge of study management and reporting needs.\n\nProven ability to collaborate in a team environment and work independently\n\nExcellent oral and written communication skills\n\n\n\nPreferred:\n\n\nWorking knowledge of and experience with Medidata Rave CTMS\n\nWorking knowledge of and experience with TransPerfect Trial Interactive eTMF\n\nProficient in MS Excel\n\nSome experience with Adobe Acrobat, creation and development of editable/fillable Adobe forms\n\nMS project or other GANTT charting and milestone development is a plus\n\nMust be a team-player, punctual and reliable, dependable and flexible in adapting to change in a multi-disciplinary, fast-paced work environment\n\n\n\n\nPrecision medicine is revolutionizing the attack on cancer—and we are passionate about helping you harness its power. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. Ultimately, we deliver robust insights that inform real-time decisions—and optimize the oncology development pathway.\n\n\nAny data provided as a part of this application will be stored in accordance with our Privacy Policy.\n\nPrecision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC\n\nIf you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected].\n \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Design, Support and Digital Nomad jobs that are similar:\n\n $60,000 — $120,000/year\n
\n\n#Benefits\n 💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nBelgrade, Belgrade, Serbia