Clinical Study Manager
2 semanas atrás
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.
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Clinical Study Manager
2 semanas atrás
Lisbon, Portugal VectorB2B - Drug Development Tempo inteiroVectorB2B 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...
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Clinical Study Manager
2 semanas atrás
Lisbon, Portugal VectorB2B - Drug Development Tempo inteiroVectorB2B 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...
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Lisbon, Portugal Decskill Tempo inteiroDecskill, 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...
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