Clinical Study Manager

Há 7 dias

Lisboa, Portugal VectorB2B - Drug Development Tempo inteiro

VectorB2B is a private association formed between Portuguese private and public partners, with the aim to gather the scattered capacities of the academic and industrial shareholders in the sector of health biotechnology. VectorB2B aims to provide integrated services in drug discovery and screening, project design and implementation, clinical contract research and contract manufacturing. Clinical Study Manager (code CSM-3225) We are seeking a Clinical Study Manager (CSM) to lead and coordinate clinical research activities within our CRO division, ensuring strict compliance with timelines, quality standards, and regulatory requirements. This role combines technical leadership, team management, operational oversight, and strategic support to the CRO Director, including involvement in proposal preparation and solution design for clients. Key Responsibilities 1. Operational Leadership of Clinical Studies Lead the implementation and execution of clinical studies, ensuring adherence to timelines, deliverables, and quality standards. Coordinate vendors, external partners, and act as the main point of contact with Sponsors. 2. Team Management and Development Mentor and guide junior team members (CTAs, CTCs, CSMs), fostering autonomy and operational consistency. Contribute to defining best practices, work standards, and continuous improvement within the team. 3. Interface with Management and Business Development Work closely with the CRO Director and Head of CRO to prioritize projects and resolve operational challenges. Collaborate with the BD team in preparing proposals, effort estimates, timelines, and project plans. Participate in client meetings when required, representing the operational perspective. 4. Regulatory and Documentation Management Ensure compliance with ICH-GCP, applicable legislation, and internal SOPs. Oversee regulatory submissions, essential documents, and TMF maintenance. Review and approve plans, reports, templates, and critical study documentation. 5. Quality, Risk, and Compliance Lead risk assessments and define mitigation plans. Ensure proper management of deviations, non-conformities, and CAPAs. Work with the Quality team to implement systemic improvements. Qualifications Degree in Life Sciences, Pharmacy, Medicine, or related field. Minimum of 3 years of experience in clinical operations within a CRO. Strong knowledge of ICH-GCP, regulatory requirements, and clinical study processes. Excellent leadership, communication, and stakeholder management skills. High attention to detail, problem-solving ability, and strategic thinking. Fluency in English (spoken and written); additional languages are a plus. Experience with project management tools and quality systems is an advantage. What do we offer? Opportunity for development and growth. Dynamic and welcoming environment. Possibility of taking part in multidisciplinary projects. Be part of a growing company. If you identify with this position and would like to apply, send your CV to and in the subject line write the code CSM-3225. * Only applications that include the position code will be accepted. ** We will only contact candidates who are selected for interview.

  • Manager, Study Start Up

    2 semanas atrás

    Lisboa, Portugal ICON plc Tempo inteiro

    Manager, Study Start Up - Poland, Czechia, Ireland, Portugal - homebased - contract management expertise requiredICON 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...

  • Study Coordinator

    Há 4 dias

    Lisboa, Portugal VectorB2B - Drug Development Tempo inteiro

    VectorB2B is a private association formed between Portuguese private and public partners, with the aim to gather the scattered capacities of the academic and industrial shareholders in the sector of health biotechnology. VectorB2B aims to provide integrated services in drug discovery and screening, project design and implementation, clinical contract...

  • Manager RASSU

    4 semanas atrás

    Lisboa, Portugal CTI Clinical Trial and Consulting Services Tempo inteiro

    Job Description Manager RASSU (Regulatory Affairs and Study Start Up) - Global Dedicated Role (EU Region) This is a senior role that requires experience in regulatory affairs, clinical trial management, and team leadership. - Responsibilities include: - Direct line management of team members, including interviewing, onboarding, performance management,...

  • Clinical Trial Manager

    1 semana atrás

    Lisboa, Portugal Amgen Tempo inteiro

    Career Category Clinical Development **Job Description**: HOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are! At Amgen, our shared mission—to serve patients—drives all that we do, which is the key for us to becoming one of the world’s leading biotechnology companies. We are global...

  • Study Coordinator

    Há 7 dias

    Lisboa, Lisboa, Portugal VectorB2B - Drug Development Tempo inteiro

    VectorB2Bis a private association formed between Portuguese private and public partners, with the aim to gather the scattered capacities of the academic and industrial shareholders in the sector of health biotechnology. VectorB2B aims to provide integrated services in drug discovery and screening, project design and implementation, clinical contract research...

  • Local Study Manager

    Há 7 dias

    Lisboa, Portugal W4Research Tempo inteiro

    W4Research is a scientific and marketing consultancy organisation working in the health domain. Our multidisciplinary team has a recognized expertise in health consulting, research and training, acquired through a vast experience in pharmaceutical industry and Contract Research Organisations, combining competences in health research, medicine, social...

  • Clinical Trial Manager

    1 semana atrás

    Lisboa, Portugal Amgen Tempo inteiro

    **HOW MIGHT YOU DEFY IMAGINATION?** If you feel like you’re part of something bigger, it’s because you are! At Amgen, our shared mission—to serve patients—drives all that we do, which is the key for us to becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together by researching, manufacturing,...

  • Clinical Research Associate

    Há 7 dias

    Lisboa, Portugal CTI Clinical Trial Services, Inc Tempo inteiro

    **Clinical Research Associate for our Lisbon office (level dependent upon experience)** **Job Purpose/Summary** As a CRA you will be responsible for the successful conduct of clinical trials and serve as main contact for the investigative site by representing CTI in a professional manner. **What You’ll Do** - Conduct evaluation, initiation, monitoring...

  • Regulatory Affairs Study Start Up Specialist II

    2 semanas atrás

    Lisboa, Portugal CTI Clinical Trial and Consulting Services Tempo inteiro

    Regulatory Affairs Study Start Up Specialist II (RASSU) Join to apply for the Regulatory Affairs Study Start‑Up Specialist II (RASSU) role at CTI Clinical Trial and Consulting Services. Responsibilities - Prepare, review, and manage regulatory submissions under CTR (Clinical Trials Regulation) using CTIS. - Handle regulatory submissions for medical...

  • Supply Chain Study Assistant

    2 semanas atrás

    Lisboa, Portugal Decskill Tempo inteiro

    Decskill, founded in 2014 as an IT Consulting Company, places paramount importance on its greatest asset: its people. Our main mission is to deliver value through knowledge and talent, and we achieve this by fostering a culture of excellence and investing in the development and well-being of our people. With over 600 dedicated professionals and offices in...