{"id":3027793,"url":"https://alion.io/job/roche-study-start-up-lead-ssul-3","title":"Study Start Up Lead (SSUL)","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":88,"open_postings":180,"ghost_share":0,"stale_share":0.672,"repost_share":0.022,"time_to_fill_p50_days":19,"computed_at":"2026-10-25T05:49:26Z"}},"role":"Biotech","role_family":"Biotech","seniority":"lead","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Shanghai, China","Beijing, China"],"countries":["CN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Good Clinical Practice","optional":true},{"name":"Veeva","optional":true}],"status":"live","first_seen_at":"2026-10-20T00:00:00Z","employer_posted_date":"2026-10-20","last_verified_at":"2026-10-24T23:50:01Z","board_verified":true,"closed_at":null,"days_open":5,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":5},"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\nKey Responsibilities\nThis role focuses on the efficient and compliant initiation of Roche-sponsored clinical trials by\ndeveloping and implementing effective start-up strategies, overseeing start-up operations, and\ndriving process improvements at the country and site level while maintaining regulatory\ncompliance.\nKey responsibilities include:\nLeading the country strategy for study start-up, driving efficiency, innovation, and collaboration with external stakeholders.\nOverseeing start-up operations and ensuring timely and efficient site activation and regulatory compliance.\nEnsuring alignment with global strategies and timelines.\nManaging amendments throughout the study lifecycle.\nIdentifying and driving opportunities for process automation, standardization, and innovation.\nCollaborating with regional and global counterparts to harmonize systems and improve timelines.\nParticipating in external industry collaborations to influence country start-up environments.\nEngaging with government and institutional bodies to align on clinical trial policies and practices (e.g., with Ethics Boards, Health Authorities).\nYou will lead in a cross functional environment in multiple of the following areas below:\nStudy Start-Up Strategy & Execution:\nLead teams in the creation of the study start-up strategy and execution of the study start-up process, encompassing strategy development, proactive risk mitigation, regulatory compliance, stakeholder liaison, tracking, knowledge management, and\ncollaborative planning with CRO partners.\nInformed Consent Form (ICF) Management:\nArchitect and strategically oversee ICF management, including preparation, submission, archiving to ensure compliance, alignment with the corporate requirements and best practices\nClinical Trial Submissions & Regulatory Coordination:\nLead the development and oversight for clinical trial submissions, amendments and regulatory coordination, managing packages, responding to queries, ensuring document maintenance, and supporting amendments throughout the trial lifecycle.\nSite Documentation & Compliance:\nStrategically manage site documentation and compliance, overseeing document collection/validation, coordination of related processes, and local vendor management (excluding CROs) if needed.\nOversee translation and approval of drug labels and patient-facing materials, as required\nMaintain up-to-date knowledge of country-specific regulations, including those for medicinal products, medical devices, and IVDRs\nBudgeting & Contract Management:\nProvide comprehensive strategic planning, oversight and implementation for all aspects of budgeting and contract management, including developing Fair Market Value-based budget strategies and drafting clinical site budgets, negotiating and implementing contracts, confidentiality disclosure agreements, indemnity/insurance documentation, and amendments, ensuring financial and legal alignment through collaboration with internal and external stakeholders, and maintaining accurate contract data in systems to support effective planning and forecasting\nPayment Oversight:\nStrategically oversee the payment processes, escalations, and reporting, ensuring financial/regulatory contract compliance and participating in planning, management, and reconciliation of financial activities.\nQualifications\nDegree (MD, PhD, MA/MS, BA/BS) in life sciences or equivalent. Postgraduate degree or master’s degree highly desirable\nDemonstrated experience in clinical trial start-up, regulatory submissions, and cross-functional collaboration\nStrong understanding of ICH-GCP, EU CTR, and local regulatory environments\nExperience managing vendor/CRO relationships\nProven leadership or line management experience (for PLs)\nSkills & Competencies\nExcellent communication and interpersonal skills\nStrong organizational, analytical, and problem-solving capabilities\nProficiency in clinical systems (Veeva Vault, CTIS, RIM, etc.)\nCollaborative and adaptable mindset with attention to detail\nAbility to lead through complexity and ambiguity, especially in matrixed and global teams\nFluency in written and spoken English is mandatory.\nFluency in written and spoken language(s) of the host country is mandatory.\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":5308,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Diagnostic Tests & IVD","Biologics & Biosimilars","Oncology Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-21T19:34:46Z"}],"visa":[],"liveness":{"score":62,"band":"ok","label":"Likely open","p_open":1,"p_active":0.62,"p_room":1,"age_days":5,"expected_fill_days":19,"reasons":["conf:5","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-10-25T05:49:26Z"},"pay":null,"html_url":"https://alion.io/job/roche-study-start-up-lead-ssul-3","json_url":"https://alion.io/job/roche-study-start-up-lead-ssul-3.json","meta":{"generated_at":"2026-10-25T19:27:36Z","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":27636,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-26T00:00:00Z"}},"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-study-start-up-lead-ssul-3"},{"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-study-start-up-lead-ssul-3"},{"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-study-start-up-lead-ssul-3"},{"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-study-start-up-lead-ssul-3\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Froche-study-start-up-lead-ssul-3"}]}