{"id":3523841,"url":"https://alion.io/job/roche-clinical-study-manager","title":"Clinical Study Manager","company":{"id":13531,"name":"Roche","domain":"roche.com","url":"https://alion.io/company/roche","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":86,"open_postings":224,"ghost_share":0.04,"stale_share":0.612,"repost_share":0.098,"time_to_fill_p50_days":19,"computed_at":"2026-10-31T05:58:55Z"}},"role":"Biotech","role_family":"Biotech","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":["Mumbai, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":21000,"max_usd":44000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":543},"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":"2026-10-30T13:19:45Z","employer_posted_date":"2026-10-30","last_verified_at":"2026-10-31T18:29:05Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.\nThe Position\nJob Title: Clinical Study manager- local studies\nLocation: (HO) Mumbai\nRole Summary: Provides leadership to study team, local strategic planning and operational delivery of assigned local clinical studies through all phases of study management (preparation, study start-up, conduct, close-out), in accordance with Roche quality standards, all applicable regulations, timelines and budget commitments.\nHow does the role serve the patients?\nProvides hands-on experience to KOLs on Innovative treatment through local phase 4, non-interventional studies, Investigator initiated studies, Real world evidence generation, Compassionate use program, Post trial access program.\nBy providing early access to innovative treatment to Indian patients. \nBy generating robust safety as well as efficacy data on Indian patients through participation in the clinical trials which in turn facilitates regulatory approvals for Roche Innovative products.\nAccountabilities\nHas full accountability and oversight for all assigned studies at country level (local studies) in accordance with the overall project plan, manages and maintains accurate study level plans (e.g. timelines, budget, resource, risk and quality plans) in the appropriate Roche planning system.\nLeads local study teams, represents Country /Region Clinical Operations at the global SMT, and provides global teams with feedback from an Affiliate perspective \nWorks with relevant global study team to manage day to day activities of the study, including monitoring report review, problem solving, issues escalation , timely closure of non-productive studies and tracking of safety procedures\nPlans and executes country study goals and commitments, and ensures compliance to relevant processes, Roche quality and safety standards, regulations, timelines and budget commitments.\nProvides operational oversight of Investigator-initiated studies and Compassionate Use studies in terms of Roche quality and safety standards, regulations, timelines and budget allocation.\nHighlights deviations and risks in plans to relevant parties, develops and implements mitigation strategies as required.\nCoaches and provides support to responsible study team members by maintaining effective communication\nProvides study oversight, leadership and support to Clinical Research Organisation (CRO) staff to ensure overall delivery at the country and site level, and interfaces with CRO Management regarding feedback on CRO staff performance as required.\nOversees study feasibility, site monitoring performance, preparation of Risk Based Monitoring plans, and ensures eTMF completeness and oversight of all relevant compliance activities for allocated studies (including translations, as applicable) \nProvides inputs to and/or develops study related materials such as Monitoring plans, recruitment plans and study Newsletters\nSupports/coordinates the negotiation of site budgets within Fair Market Value guideline, budget plans and provide oversight for site payments as per contract, as required.\nParticipates in local quality/compliance reviews, internal audits, and regulatory inspections, ensuring inspection readiness at all times and completion of Corrective and Preventative Actions for allocated studies.\nDevelops and maintains optimal site relationships with key investigator sites, alliance partners and/or collaborative group for current and future Roche studies.\nParticipates in overall therapeutic area support together with the therapeutic leads and country experts (e.g. landscaping activities, investigator/site development activities or affiliate cross functional teams, etc.), as required.\nPerforms/coordinates for Health Authority presentation for the study/protocol amendments.\nFor Local Studies, provides the leadership and clinical operations expertise for the local study team.\nInternal Stakeholders\nAll Medical functions, Procurement, Legal, Finance\nExternal Stakeholders\nHCPs and HCOs, Regulatory authorities, Industry Bodies, Patient Support Groups and Vendors\nFunctional Competencies\nKnowledge of ICH-GCP, Indian Regulations, multiple therapy area knowledge, technical expertise in the field of clinical operation, vendor management\nBehavioral Competencies\nExhibition of Roche Core Values, Exhibition of Servant Leadership, Patient centricity in decision making, Strong Collaboration and Networking skills, Inspiring and Influencing\nEligibility Criteria (Qualification and Experience)\nUniversity degree or equivalent; professional qualification preferably in a medical/science related field Pharmaceutical medicine training highly desirable\nHigher degree and / or specialist accreditation desirable\nEmployee has completed minimum 1 year with Roche Pharma (Applicable for internal hire)\nEmployee having an overall experience of minimum 5 years in Pharmaceutical / Biotech / Clinical Research industry with minimum 5 years in Clinical Operations.\nClinical operations and quality assurance\n Job Location: Mumbai (HO)\nWillingness to relocate \nWho we are\nA healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.\nLet’s build a healthier future, together.\nRoche is an Equal Opportunity Employer.","description_format":"text","description_chars":6090,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":true,"industries":["Prescription Drugs","Diagnostic Tests & IVD","Biologics & Biosimilars","Oncology Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-30T13:19:45Z"}],"visa":[],"liveness":{"score":63,"band":"ok","label":"Likely open","p_open":1,"p_active":0.632,"p_room":1,"age_days":0,"expected_fill_days":19,"reasons":["conf:1","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-10-31T05:58:55Z"},"pay":null,"html_url":"https://alion.io/job/roche-clinical-study-manager","json_url":"https://alion.io/job/roche-clinical-study-manager.json","meta":{"generated_at":"2026-11-01T04:47:53Z","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":7401,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-02T00:00:00Z"}},"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":13531},"rest":"https://alion.io/mcp/rest/get_company?id=13531"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Froche-clinical-study-manager"},{"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%2Froche-clinical-study-manager"},{"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%2Froche-clinical-study-manager"},{"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/roche-clinical-study-manager\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Froche-clinical-study-manager"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3523841}},{"tool":"search_jobs","arguments":{"company":"roche.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3523841},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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