{"id":3050862,"url":"https://alion.io/job/icon-clinical-study-manager-2","title":"Clinical Study Manager","company":{"id":5677,"name":"ICON","domain":"iconplc.com","url":"https://alion.io/company/icon","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"senior","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Warsaw, Poland"],"countries":["PL"],"hiring_countries":["PL"],"hiring_countries_total":1,"salary":null,"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Good Clinical Practice","optional":false}],"status":"live","first_seen_at":"2026-10-21T00:00:00Z","employer_posted_date":"2026-10-21","last_verified_at":"2026-10-22T03:45:51Z","board_verified":false,"closed_at":null,"days_open":3,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":3},"description":"POL-HB-PMAt ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.\nAs the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.\nAs a Project Manager at ICON, working as an FSP Clinical Study Manager, exclusively dedicated to one pharmaceutical company, you will be responsible for leading and coordinating project activities, ensuring that global trials are delivered on time, within budget, and to the highest quality standards.\nWhat You Will Do:\nYour focus will be on supporting aspects of operational delivery, working in close collaboration with the Global Trial Study Leader:\nKey responsibilities may include:\nSupporting the execution of select studies in compliance with quality standards (including ICH GCP, local regulations and SOPs), on schedule and on budget.\nAccountable for planning and operational execution for specific tasks within assigned clinical trials. Coordinating with functional leads, ensuring milestone delivery and project objectives are met. \nOversight of Strategic Partners - CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner for assigned studies, including escalation of issues to governance committees when warranted.Specific areas of sponsor oversight include, but are not limited to:\nReview and approval of key monitoring documents/plans, periodic review of outputs, decisions and actions related to monitoring\nConduct Oversight Monitoring Visits, as applicable\nReview and endorsement of relevant study plans, as applicable\nStudy team meeting management and attendance when necessary; regular review of meeting agendas and minutes\nReview of outcomes/actions related to protocol deviations review; primary purpose of review is to support the identification of trends across sites and/or the study\nDocumented review and monitoring of issues, risks and decisions at the study level and implementation of appropriate mitigation strategies\nReview and ownership of trial operational data (e.g. CTMS)\nReview and provide oversight of internal trial reports\n\nEnsure studies are “inspection ready” at all times; may be involved in regulatory inspections by preparing for and/or attending the inspections. \nPreparation for Agency inspections, including document readiness, tracking, storyboard development and other pertinent documents and preparations\nSupport data review for database lock and CSR writing and review (including appendices)\nCollect/review/File study documents in support of the trial master file (TMF) \nCollect/review/File study documents in support of the regulatory filing\nYour Profile:\nRequired qualifications and experience:\nYou will have 5+ years’ experience in pharmaceutical industry and/or clinical research organization, including 3+ years clinical study management oversight, including significant study management support experience (As Project Manager/ CTM on global level). Experience could include either early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs. Experience in more than one therapeutic area is advantageous.\nProven track record of successfully managing projects, with a focus on delivering results within scope, time, and budget constraints.\nExperienced in vendor selection and oversight\nStrong leadership and organizational skills, with the ability to effectively manage project teams and prioritize tasks.\nExcellent communication and interpersonal skills, with the ability to build relationships and manage stakeholder expectations.\nKnowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements may also be required.\nProficiency in project management tools and methodologies, with certifications such as PMP or PRINCE2 being advantageous.\nDetail-oriented, proactive, and adaptable, with a commitment to achieving project goals and driving continuous improvement.\nFluent business English (oral and written)\nTravel Requirements are minimal. The opportunity for travel to support a key trial meeting may occasionally arise.\nEmployment with ICON is contingent upon having the legal right to work in the country where the role is based.\nRewards & Benefits\nICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.\nBenefits may include:\nCompetitive base salary and performance related incentives\nHealth and wellbeing programmes including medical, dental, and vision coverage where applicable\nRetirement and pension plans\nLife assurance and disability coverage\nEmployee assistance programmes and wellbeing resources\nLearning and development opportunities through structured training and career pathways\nBenefits may vary depending on role and location.\nVisit our careers site to read more about the benefits ICON offers.\nInclusion and Accessibility\nICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.\nIf you require reasonable accommodations during the recruitment process, please let us know or submit a request here.\nAre you a current ICON Employee? Please click here to apply","description_format":"text","description_chars":5503,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[{"language":"English","level":"Upper-Intermediate (B2)","optional":false}]},"benefits":["Retirement plans"],"hiring_locations":[{"name":"Poland","iso":"PL","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Clinical Trial Services (CRO)"],"lifecycle":[{"event":"open","at":"2026-10-22T02:26:09Z"}],"visa":[],"liveness":{"score":81,"band":"hot","label":"Hiring now","p_open":0.9,"p_active":0.903,"p_room":1,"age_days":3,"expected_fill_days":30,"reasons":["conf:50","velocity","win:early","comp:brand"],"computed_at":"2026-10-24T06:02:35Z"},"pay":null,"html_url":"https://alion.io/job/icon-clinical-study-manager-2","json_url":"https://alion.io/job/icon-clinical-study-manager-2.json","meta":{"generated_at":"2026-10-24T17:02:59Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":24697,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-25T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":5677},"rest":"https://alion.io/mcp/rest/get_company?id=5677"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Ficon-clinical-study-manager-2"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Ficon-clinical-study-manager-2"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Ficon-clinical-study-manager-2"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/icon-clinical-study-manager-2\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Ficon-clinical-study-manager-2"}]}