{"id":3010633,"url":"https://alion.io/job/merck-co-clinical-operations-manager-2","title":"Clinical Operations Manager","company":{"id":3768,"name":"Merck & Co.","domain":"msd.com","url":"https://alion.io/company/msd","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":99,"open_postings":118,"ghost_share":0.008,"stale_share":0.136,"repost_share":0.127,"time_to_fill_p50_days":15,"computed_at":"2026-10-28T05:59:10Z"}},"role":"Management","role_family":"Management","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Lisbon, Portugal"],"countries":["PT"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":45000,"max_usd":101000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":6904},"experience_years_min":5,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GCP","optional":false},{"name":"Good Clinical Practice","optional":false},{"name":"IVDR","optional":false}],"status":"live","first_seen_at":"2026-10-21T15:18:02Z","employer_posted_date":"2026-10-21","last_verified_at":"2026-10-28T11:51:44Z","board_verified":true,"closed_at":null,"days_open":6,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":6},"description":"Job Description\nReporting to the Clinical Research Country Lead, an exciting opportunity has arisen for a Clinical Operations Manager. This position is responsible for ensuring the performance, compliance, and execution of assigned clinical trial protocols within the country, in accordance with ICH-GCP guidelines, local regulatory requirements, company policies, quality standards, and safety reporting obligations.\nThe role plays a critical part in supporting study start-up, regulatory submissions, financial management, and operational delivery of clinical trials. Working closely with internal stakeholders, investigators, vendors, and regulatory authorities, you will help drive study success while ensuring compliance and operational excellence.\nWhat you will do:\nBring energy, knowledge, innovation and leadership to carry out the following:\nLead and oversee country-level study start-up activities, including clinical trial submissions, approvals, ethics committee interactions, and regulatory authority communications.\nManage local study operations, including informed consent, clinical and ancillary supplies, import/export requirements, archiving, insurance processes, and compliance documentation.\nOwn country and site budget management, financial compliance, payment processes, and the development, negotiation, and execution of Clinical Trial Research Agreements (CTRAs).\nCollaborate with internal functions including Finance, Legal, Regulatory Affairs, and Pharmacovigilance, as well as external vendors, to ensure timely delivery of study milestones.\nDrive process improvements, contribute to local Standard Operating Procedures, and serve as a Subject Matter Expert for assigned operational topics.\nSupport talent development through mentoring, onboarding, while contributing to strategic local initiatives and projects.\nWhat skills you will need:\nIn order to excel in this role, you will more than likely have:\nBachelor's Degree in Life Sciences, Business Administration, Finance, Healthcare, or a related discipline.\nMinimum 5 years of experience in clinical research or a combination of clinical research and finance/business operations.\nStrong knowledge of clinical trial regulations, ICH-GCP, local regulatory requirements, and study start-up processes.\nProven experience in budget management, contract negotiations, and Clinical Trial Research Agreements (CTRAs).\nSolid understanding of the European Clinical Trials Regulation (EU CTR), including submission requirements and timeline, and of European Union In Vitro Diagnostic Regulation (IVDR).\nExcellent problem-solving and critical thinking skills, with the ability to identify risks, determine root causes, and implement effective solutions.\nStrong communication, stakeholder management, negotiation, conflict resolution, and cross-functional collaboration skills.\nProficiency in clinical systems, digital technologies, and AI-enabled tools supporting clinical operations.\nFluent written and verbal communication skills in both Portuguese and English.\nTravel: Approximately 15% domestic and international travel may be required.\nWhy Join Us?\nAs a company, we keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.\nWe are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.\nSo, if you are ready to contribute to the delivery of innovative clinical research and make a meaningful impact on patients' lives, please apply today.\nAdditional location(s) Compensation Information:\nRequired Skills:\nAdaptability, Adaptability, Business Management, Clinical Development, Clinical Information Systems, Clinical Operations, Clinical Research, Clinical Site Management, Clinical Trial Agreements (CTA), Clinical Trial Compliance, Clinical Trial Documentation, Clinical Trial Management, Clinical Trial Planning, Clinical Trials Monitoring, Clinical Trials Operations, Conceptual Thinking, Conflict Management, Critical Thinking, Cross-Cultural Awareness, Data Operations, Good Clinical Practice (GCP), Healthcare Delivery Systems, ICH GCP Guidelines, Lateral Thinking, Liaison Work {+ 7 more}Preferred Skills:\nCurrent Employees apply HERE\nCurrent Contingent Workers apply HERE\nSearch Firm Representatives Please Read Carefully\nMerck & 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.\nEmployee Status:\nRegularRelocation:\nVISA Sponsorship:\nTravel Requirements:\nFlexible Work Arrangements:\nNot ApplicableShift:\nValid Driving License:\nHazardous Material(s):\nJob Posting End Date:\n11/2/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. 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