{"id":3795243,"url":"https://alion.io/job/penumbra-manager-clinical-study-start-up","title":"Manager, Clinical Study Start-Up","company":{"id":4897,"name":"Penumbra","domain":"penumbrainc.com","url":"https://alion.io/company/penumbra","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Lever","truth_index":{"grade":"B","score":80,"open_postings":11,"ghost_share":0,"stale_share":0.818,"repost_share":0,"time_to_fill_p50_days":55,"computed_at":"2026-11-10T06:52:35Z"}},"role":"Biotech","role_family":"Biotech","seniority":"senior","employment_type":null,"work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":[],"countries":[],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":135000,"max":187000,"currency":"USD","period":"year","gross":null,"usd_annual":187000},"salary_estimate":null,"experience_years_min":7,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"Microsoft Office","optional":true}],"status":"live","first_seen_at":"2026-11-03T01:48:56Z","employer_posted_date":"2026-11-03","last_verified_at":"2026-11-10T10:29:07Z","board_verified":true,"closed_at":null,"days_open":7,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":7},"description":"General Summary\nThe Manager of Clinical Study Start-Up leads the in-house Clinical Research Associate (ICRA) and Clinical Budget Analyst (CBA) teams and oversees study and site start-up activities, including regulatory documentation, site support tools, clinical site budgets, vendor management, and site activation. The role establishes and applies start-up best practices, represents Clinical Operations on cross-functional project teams, partners with our Clinical Study Management and Legal teams, and provides strategic and tactical leadership for Penumbra-sponsored clinical studies. This position is also responsible for hiring, coaching, mentoring, resource planning, and anticipating future staffing needs.\nSpecific Duties and Responsibilities\nLead a team that supports study and site start-up execution, amendment submissions and approvals, activation process, and final site closure activities. *\nLead or supervise development of study start-up materials, and other study documents, e.g., consent templates, questionnaire licensing, study manuals. *\nLead and oversee the preparation and negotiation of initial clinical trial budgets and budget amendments with clinical study sites across multiple clinical studies. *\nOversee and support the timely registration, maintenance, results reporting, and closure of clinical studies in publicly accessible registries, such as ClinicalTrials.gov, in accordance with applicable requirements. *\nProvide periodic updates to management regarding site start-up progress related to their strategic impact. Communicate potential or actual delays and propose actions to ensure that project timelines are met. *\nEstablish, monitor, and report study start-up performance and quality metrics to identify trends, drive timely corrective actions, and support continuous improvement across clinical studies. *\nProvide oversight and guidance to clinical staff in the preparation and follow-up of Institutional Review Board (IRB) and Ethics Committee (EC) submissions, including the development and coordination of responses to review comments and request additional information. *\nLeads continuous improvement initiatives for clinical processes, systems, tools, and procedures; drives the review, development, and implementation of SOPs and work instructions; and promotes consistent compliance with applicable requirements across clinical studies. *\nRecruits, hires, and directly supervises ICRA and CBA team members, including goal setting, development planning, training, coaching, ongoing performance feedback, and performance reviews. *\nAllocates resources across studies and manages project timelines to meet departmental and company goals.*\nIdentifies and escalates site- and study-related issues to management. *\nServes as the key liaison between cross-functional teams and establishes, communicates, and aligns goals and priorities for the ICRA and CBA teams. *\nAdhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. *\nUnderstands relevant security, privacy and compliance principles and adheres to the regulations, standards, and procedures that are applicable to the Company. *\nEnsure other members of the department follow the QMS, regulations, standards, and procedures. *\nPerform other work-related duties as assigned.\n*Indicates an essential function of the role\nRequired Qualifications\nMinimum education and experience:\nBachelor's degree in Biology, Nursing, Biomedical or Physical Sciences or related field with 7+ years of experience in preclinical research, or medical devices/pharmaceutical industry, or an equivalent combination of education and experience.\n3+ years’ experience in the operational aspects of managing clinical studies from start-up to close-out, vendor management, and planning cross-functional operational activities required.\nKnowledge of ICH-GCPs and 21 CFR, and other relevant regulations and standards.\nExperience creating and negotiating clinical budgets and contracts.\nExtensive clinical research knowledge and cross-functional understanding of clinical trial methodology.\nPreferred Qualifications:\nMedical device experience desirable\nStrong oral, written, and interpersonal communication skills\nExcellent organizational skills, with ability to prioritize assignments while handling various projects simultaneously\nStrong computational skills; proficiency with Microsoft Office (Word, Excel, OneNote, and PowerPoint)\nAbility to apply strong analytical, business and communication skills, as well as technical standards, principles, theories, concepts, and techniques.\nWorking Conditions\nGeneral office environment\nWillingness and ability to work on site.\nMay have business travel from 0% - 10%\nPotential exposure to blood-borne pathogens\nRequires some lifting and moving of up to 15 pounds\nMust be able to move between buildings and floors.\nMust be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.\nMust be able to read, prepare emails, and produce documents and spreadsheets.\nMust be able to move within the office and access file cabinets or supplies, as needed.\nMust be able to communicate and exchange accurate information with employees at all levels daily.\nSalary Range: $135,000 - $187,000\nThis is the pay range for a mid-cost labor market. If hired in another region, there will be a difference in pay range. We offer a competitive compensation package plus a benefits and equity program, when applicable. Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.","description_format":"text","description_chars":5718,"description_truncated":false,"requirements":{"experience_years_min":7,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Surgical Instruments & Devices","Cardiovascular Devices"],"lifecycle":[{"event":"open","at":"2026-11-05T09:04:51Z"}],"visa":[{"country":"US","licensed_sponsor":true,"adverts_offering_sponsorship_24m":0,"sanctioned_now":false,"evidence":"H-1B filings in 12 months: 47 · green card filings: 16","filings_12m":47,"filings_prev_12m":31,"green_card_filings_12m":16,"median_offered_wage_usd":125040,"route":null,"cap_exempt":false,"checked_at":"2026-11-10T11:34:35+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":63,"band":"ok","label":"Likely open","p_open":1,"p_active":0.632,"p_room":1,"age_days":7,"expected_fill_days":55,"reasons":["conf:1","stale_co","velocity","win:early"],"computed_at":"2026-11-10T06:52:35Z"},"pay":{"stated_usd_annual":187000,"is_top_pay":true},"html_url":"https://alion.io/job/penumbra-manager-clinical-study-start-up","json_url":"https://alion.io/job/penumbra-manager-clinical-study-start-up.json","meta":{"generated_at":"2026-11-10T14:11:50Z","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":32970,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-11T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"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":4897},"rest":"https://alion.io/mcp/rest/get_company?id=4897"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fpenumbra-manager-clinical-study-start-up"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":2,"usd":0.2},"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%2Fpenumbra-manager-clinical-study-start-up"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"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%2Fpenumbra-manager-clinical-study-start-up"},{"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/penumbra-manager-clinical-study-start-up\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fpenumbra-manager-clinical-study-start-up"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3795243}},{"tool":"search_jobs","arguments":{"company":"penumbrainc.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3795243},"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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