Senior Clinical Research Associate
2 semanas atrás
Job DescriptionWe are one of the leading pharmaceutical companies in the world, dedicated to the discovery, development, and delivery of innovative medicines that improve health and quality of life for people. With a strong global presence and an unwavering commitment to scientific research, our mission is to transform health through innovation and excellence in healthcare. We value diversity and inclusion, fostering a collaborative work environment where all employees can contribute their ideas and talents. We believe that our strength lies in the people who are part of our team, and we are constantly looking for passionate and dedicated professionals who want to make a difference. We are recruiting aSeniorClinical Research Associate (CRA) to join our dynamic team in Portugal.This is a unique opportunity for professionals who wish to contribute to the execution of high-quality clinical studies and have a strong interest in driving innovation in the healthcare field. If you are looking for a stimulating and challenging environment where you can grow and develop your career, we are the right place for you. Come be a part of our mission to improve lives around the worldIn our company, the Senior CRA Will be accountable for performance and compliance for assigned protocols and sites in Portugal. Ensures compliance of study conduct with ICH/GCP and country regulations, our policies and procedures, quality standards and adverse event reporting requirements internally and externally. Ensures subjects' rights, safety and well-being are protected. Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. Performs clinical study site management/monitoring activities, remote and onsite, in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. Participates & provides inputs on site selection and validation activities. Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required. Availability to travel approximately 65%-75% of the working time (2 to 3 days of travel per week).Experience and Education Bachelor's degree in a health-related field. Min. 4 years of direct site monitoring experience in a bio/pharma/CRO. Fluent in Portuguese and English (spoken and written), with excellent written and oral communication skills. Skills And Qualifications Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines Proven Skills in Site Management including management of site performance and patient recruitment Experience in conducting clinical trials (validation visits, initiation, ongoing, and closure). Ability to understand and analyze data/metrics and act appropriately Ability to manage complex scenarios, working solution-oriented. Good IT skills (MS Office) and knowledge of clinical trial management tools. Valid driving license. Behavioral Competencies Proactive, with a positive mindset and problem-solving orientation. Responsible and results-focused. Detail-oriented and organized. Ability to prioritize tasks and manage multiple requests autonomously. Capacity to coach junior colleagues Good adaptability to a multicultural environment and ability to work in multidisciplinary teams. Required SkillsAccountability, Accountability, Adaptability, Adverse Event Report, Animal Vaccination, Clinical Data Management, Clinical Development, Clinical Medicine, Clinical Research, Clinical Research Organizations (CRO) Management, Clinical Sciences, Clinical Site Management, Clinical Study Management, Clinical Trial Compliance, Clinical Trial Documentation, Clinical Trial Management, Clinical Trial Planning, Clinical Trials, Clinical Trials Monitoring, Customer-Focused, Disease Prevention, Good Clinical Data Management Practice (GCDMP), Medical Research, Organizational Performance Management, Patient Recruitment {+ 3 more} Preferred SkillsCurrent Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read CarefullyMerck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee StatusRegular RelocationVISA SponsorshipTravel RequirementsFlexible Work ArrangementsHybrid ShiftValid Driving LicenseHazardous Material(s)Job Posting End Date11/19/2025 A job posting is effective until PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition IDR
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