Principal Clinical Scientist, Clinical Science Analytics

hace 5 días

España Precision Medicine Group A tiempo completo

Precision for Medicine is recruiting an experienced Principal Clinical Scientist to work remotely in Poland, Hungary, Serbia, Romania, Slovakia, Spain, or the UK.Position Summary:The Principal Clinical Scientist must have a strong working knowledge of medical and oncology standards applicable to clinical trials, preferably in the area of solid and liquid tumors. The Principal Clinical Scientist manages the operational clinical science function from study start-up through database lock for assigned projects focused on scientific and indication-specific insights into data collection and data visualization outputs to support scientific, clinical-sense data cleaning as part of Precision's cross-functional data review team. This role serves as the subject matter expert in the application of clinical knowledge, guidelines, and standards of care to the review of clinical trial data. A medical-related degree is required (RN, OCN, RPH, PharmD, etc.).Essential functions of the job include but are not limited to:Serve as the functional lead implementing CSAI services per study scope of work (SOW) on assigned project team(s).Serve as a resource for project teams regarding scientific-related data capture, review, and cleaning.Support and participate in the development and implementation of process flow for integrated, cross-functional data cleaning for interim and/or final study data deliverables between all applicable departments (e.g., data management, medical, safety, vendors, sponsor, etc.).May be responsible for cross-functionally managing the overall data cleaning process internally to support interim and/or final data deliverables (e.g., tier cleaning process/timelines, etc.).Manage Medical Monitor review of subject data.Provide protocol review from a scientific operational perspective.Provide indication-focused, scientific, clinical input and support to Data Management in the development and revision of eCRF specifications, edit checks, and completion guidelines and/or other study-specific documentation as applicable.Provide indication-focused, scientific, clinical input and support to Data Management in the conduct of EDC UAT supporting the CSAI function as applicable.Collaborate to support cross-functional departmental communication including internal CSAI communication as applicable on data capture, review trends, EDC updates, CSAI Programming needs, etc.Support the identification of study risks including the management to correct any CSAI study-specific deficiencies.Support Project and Financial Management on monthly invoicing and variance management of the CSAI budget.Collaborate with CSAI management to ensure that CSAI resource needs are adequately addressed due to scope of work changes.Oversee and/or develop and maintain CSAI project-related plans, guidelines, and trackers.Ensure applicable eTMF documentation related to CSAI is maintained as per study project plans and SOPs.Support and/or conduct holistic and/or aggregate scientific, clinical sense data review based on defined manual Clinical Data Review Guidelines using various programmed outputs including but not limited to Smart Patient Profiles, Smart All-Patient-Data Workbook, listings, quality metrics, and/or graphs.Oversee and/or issue and resolve queries in various EDC systems.Review and/or provide routine status updates on CSAI data review findings and escalate issues as appropriate.Manage and/or conduct the development and associated User Acceptance Testing (UAT) of CSAI programmed output(s).Provide study-specific training for CSAI Scientists, project teams, and/or study sites based on review findings.Participate in internal and external study-specific team meetings and/or presentations as applicable including facilitating CSAI meetings or topics.May support study-specific data-related committees and/or meetings (e.g., safety review committee).May conduct review of Table, Figure, and Listings (TLFs) and/or clinical study reports (CSRs).May participate in the interview process of potential new CSAI candidates.May participate in business development activities including proposal development and client presentations as applicable.Performs other duties as assigned by management.Qualifications:Minimum Required:Bachelor's degree or equivalent combination of education/experience in a science or health-related discipline with proficiency in medical terminology.Minimum of 8 years of clinical research experience or proven competencies for this position.Minimum of 1 year of leadership experience.Other Required:Oncology therapeutic experience required, with the ability to apply working knowledge (e.g., understanding of clinical and oncology standards of care and associated side effects, biomarkers, etc.) to data review.Experience in trial phases I, II, and III.On-site monitoring experience and/or data review experience (previous experience as a Clinical Research Associate (CRA) or Study Coordinator or Research Nurse preferred).Experience with electronic data capture systems (EDC) and data visualization tools (such as JReview).Computer proficiency.Professional use of the English language; both written and oral.Working knowledge of FDA and ICH/GCP regulations and guidelines.Ability to occasionally travel domestically and internationally including overnight stays.Highly Preferred:Medical-related degree, RN, OCN, RPH, PharmD, etc.Database build experience.Competencies and Skills:Demonstrates highly advanced knowledge in oncology and medical terminology with the ability to apply knowledge to clinical trial data including the application of disease assessment criteria, standards of care, grading criteria, etc.Desire to continually learn and keep up to date on medical and oncology standards of care with the ability to self-research and educate.Working knowledge of FDA and ICH-GCP, relevant SOPs, and regulatory guidance with a well-rounded knowledge of the entire clinical trial process and working understanding of clinical research functional departments.High level of integrity from a professional and ethical perspective.Ability to independently manage the CSAI operational function in a global, cross-functional environment with awareness of appropriate escalation.Excellent time management, negotiation, critical thinking, decision-making, analytical, and conflict management skills with the ability to strategically plan and apply effective risk management.Exhibits self-motivation with the ability to work remotely while independently lead, support, and inspire excellence.Demonstrates the ability to adjust to multiple demands and shifting priorities.Results-oriented, accountable, motivated, cooperative, and flexible.Ability to apply financial management skills at the functional area project level.Excellent presentation, verbal, and written communication skills.
#J-18808-Ljbffr

  • Clinical Data Scientist

    hace 2 semanas

    España Cataloxy A tiempo completo

    Publicada: 20.12.2024. Actual hasta: 03.01.2025Ofertas de empleo Clinical Data ScientistPSI CRO Spain, SLUClinical Data Scientist, MadridSalario: a convenirSummary informationPuesto: Clinical Data ScientistPublicada: 20.12.2024. Actual hasta: 03.01.2025Área: Otras - sin clasificarJornada laboral: completaSexo: indiferenteEmpresa: PSI CRO Spain,...

  • Senior Clinical Development Scientist

    hace 2 semanas

    España Almirall A tiempo completo

    Date: 20 Dec 2024Location: SFEL - R&D SANT FELIU DE LLOBR, ES, ES - SpainCompany: AlmirallMissionThe Senior Clinical Development Scientist collaborates closely with Global Clinical Program Lead (GCPL) on all scientific and clinical aspects of the clinical program, as well as providing scientific/clinical support for the program/clinical studies execution. In...

  • Senior Clinical Safety Scientist

    hace 4 semanas

    España Daiichi Sankyo Europe A tiempo completo

    Passion for Innovation. Compassion for Patients. With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. In Europe, we focus on two areas:The goal of our Specialty Business is to protect...

  • Clinical Studies Scientist

    hace 4 semanas

    España Werfenlife SA. A tiempo completo

    Coordinate clinical studies execution in clinical sites world-wide.Provide support to principal investigators and their team: on-site trainings, monitoring of sites and clinical data, manage study-related administration and logistics tasks.Ensure that studies and data management are performed in compliance with GCP, Ethical and Regulatory...

  • Clinical Data Scientist

    hace 2 semanas

    España PSI CRO A tiempo completo

    We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,700 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.Job...

  • Principal Clinical Data Standards Consultant

    hace 2 meses

    España ICON plc A tiempo completo

    Principal Clinical Data Standards Consultant - EMEA ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Principal Clinical...

  • Associate Clinical Science Development Director, EMEA

    hace 1 mes

    España Thermo Fisher Scientific A tiempo completo

    Including:Develop, design, and optimize clinical trial protocol synopses and full Phase I-IV clinical trial protocols.Clinical science liaison activities including supporting KOLs, PIs, and clinical trial sites.Contribute to clinical trial scientific deliverables by providing scientific review and input to key study documents ensuring scientific rigor,...

  • Clinical Contract Specialist Spain

    hace 2 meses

    España Resourcing Life Science A tiempo completo

    Company Description Our client is a Global CRO currently supporting various Pharmaceutical & Biotech companies globally. They offer a full service solution encompassing clinical & non-clinical development, peri-approval & market access. They are currently seeking a Clinical Contract Specialist office based in Spain. Job Overview Prepare & negotiate site...

  • Associate Medical Director Clinical Science

    hace 1 mes

    España Sobi A tiempo completo

    Company DescriptionAt Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.Here at Sobi, our mission and culture get us excited...

  • Senior Clinical Development Scientist

    hace 5 días

    España Almirall Hermal GmbH A tiempo completo

    Select how often (in days) to receive an alert:MissionTasks and ResponsibilitiesCore member of the Global Project Team and Strategic Clinical Team.Supports the GCPL on the design of clinical development plans (focus on critical review of studies from competitors and aiming to optimize the clinical quality of the clinical design) for internal assets.Provides...

  • Senior Clinical Programmer

    hace 4 semanas

    España AstraZeneca GmbH A tiempo completo

    Job Title - Senior Clinical ProgrammerCareer Level - DIntroduction to roleAre you ready to take on a pivotal role in transforming clinical trials through innovative programming and data visualization? As a Senior Clinical Programmer I, you will be at the forefront of developing and validating complex programs and dashboards for ongoing clinical studies. Your...

  • Clinical IT Senior Manager

    hace 2 semanas

    España Jordan martorell s.l. A tiempo completo

    Clinical IT Senior Manager - EuropeWondering what’s within Beckman Coulter Diagnostics? Take a closer look. At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re...

  • Principal Medical Writer

    hace 4 semanas

    España Syneos - Clinical and Corporate - Prod A tiempo completo

    Description Principal Medical Writer Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center...

  • Principal Medical Writer

    hace 4 semanas

    España Syneos - Clinical and Corporate - Prod A tiempo completo

    Description Principal Medical Writer Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center...

  • Associate Medical Director Clinical Science

    hace 1 mes

    España Sobi group A tiempo completo

    Associate Medical Director Clinical ScienceFull-timeSobi Location: United StatesStatistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!At Sobi,...

  • Senior Clinical Programmer I

    hace 2 semanas

    España AstraZeneca GmbH A tiempo completo

    Job Title: Senior Clinical Programmer ICareer Level - D1Introduction to roleAs a Senior Clinical Programmer I, you will be at the forefront of programming, dashboard development, and validation of data cleaning and review listings for ongoing clinical studies. This role demands high technical skills and industry knowledge to independently perform programming...

  • Clinical Pharmacology Expert

    hace 3 semanas

    España AstraZeneca GmbH A tiempo completo

    Do you have expertise and experience in clinical pharmacology, PK, PKPD, Model Informed Drug Development (MIDD) and its application in drug development? Would you like to apply your strategic expertise in a company that is following the science and turn ideas into life changing medicines? If yes, we have the position for you!We now have an exciting...

  • Biostatistician for Clinical Algorithms

    hace 4 semanas

    España F. Hoffmann-La Roche Gruppe A tiempo completo

    Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...

  • Senior/Principal Clinical Team Manager |

    hace 2 semanas

    España Importante empresa del sector A tiempo completo

    Our team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our Clinical Research team, who powers our PPD clinical research portfolio, are part of our leading global...

  • Clinical IT Senior Manager

    hace 2 semanas

    España Danaher - Global A tiempo completo

    Wondering what’s within Beckman Coulter Diagnostics? Take a closer look.At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates...