{"id":3271748,"url":"https://alion.io/job/insightec-sr-clinical-project-manager","title":"SR Clinical Project Manager","company":{"id":49191,"name":"Insightec","domain":"insightec.com","url":"https://alion.io/company/insightec","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Comeet","truth_index":null},"role":"Management","role_family":"Management","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":["Miami, United States"],"countries":["US"],"hiring_countries":["US"],"hiring_countries_total":1,"salary":null,"salary_estimate":{"min_usd":100000,"max_usd":181000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":832},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Amazon ECS","optional":false},{"name":"EU MDR","optional":false},{"name":"FDA 510(k)","optional":false},{"name":"GCP","optional":false},{"name":"Good Clinical Practice","optional":false}],"status":"live","first_seen_at":"2026-08-05T18:16:46Z","employer_posted_date":"2026-08-05","last_verified_at":"2026-11-01T19:09:53Z","board_verified":true,"closed_at":null,"days_open":88,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":88},"description":"Description\nInsightec is a growing medical technology company transforming patient lives through innovative incisionless surgery.\nOur culture is as unique as our people, a diverse global team, with different ideas, skills, interests, and cultural backgrounds driven by our core values - Our Patients, Integrity, Team, Quality and Innovation.\nOur dedication to making a real impact on the lives of millions of people and paving the path to a bright future for healthcare, is what bonds us as a Team. We work together in a dynamic collaborative environment to deliver successfully while believing and driving a life-work balance philosophy that encourages our employees to do things that are meaningful outside of work. Every role is significant, your voice is heard, and your ideas are encouraged. We challenge and empower our people to be great at what they do while providing a flexible work environment.\nWalking through our corridors, you will be inspired by stories of career journeys at Insightec. We take pride in growing internal talent and encourage our employees to achieve their professional ambitions. With employees in Israel - Haifa and K. Ono, Miami and Dallas, Shanghai, Tokyo and Europe, we offer in each region competitive perks and benefits.\nDo the most meaningful work of your career by joining us on our mission to transform tomorrows, today.\nResponsibilities:\nResponsible for independently leading the clinical trial study team and managing global clinical trial activities on a pivotal trial or multiple feasibility trials from start-up through study closeout in a manner that manages risk and ensures compliance with the protocol, GCP, and the local governing regulations.\nEffectively communicates and guides / directs the activities of the clinical team members through all the details of large and complex trials, to include regulatory compliance, high quality data collection, and audit readiness that will lend itself to regulatory process approvals.\nPartners effectively with R&D, Regulatory, Quality, Marketing/Product stake-holders, supports the regulatory processes with regulatory writing, strategy development, and corrective actions as needed.\nResponsible for management of all clinical studies including activities such as but not limited to:\nDeveloping project management plans, strategy, cost and timelines\nIdentification, qualification, and training of investigators and their teams\nContribute to protocol writing/amendments, regulatory deficiencies, annual progress reports, final study reports\nResponsible for the activities related to IRBs/ECs, and clinical study vendors (e.g.. core lab, statistical consultants, etc.)\nDevelops SAE narratives for DSMB review and manages oversight of the safety profile as per the protocol/stopping rules, local regulations, and IRB.\nProactively manage the data management and data lock processes of the clinical trial and takes an active role in the final clinical study reporting process\nResponsible for great site relationships with the PI and coordinator to establish trust and collaboration between both parties.\nEnsure annual regulatory reporting is crafted, updated and submitted in a timely fashion.\nAssist/support preparation of registration packages, and activities requiring regulatory agency approvals\nImplement solid strategy, scope, process, and programs related to clinical trials including leading SOP creation, guidelines, and work instructions.\nEffectively communicate scientific information to key stakeholders and support publication activities\nProvide training on disease, indication, protocol, etc to cross-functional teams as well as external collaborators.\nProvide leadership in the development of other clinical project managers within the Global Clinical Affairs team as a mentor\nProvide significant and positive impact to short-term, mid-range, and long-term organizational goals\nDemonstrate process improvement in product/system development related matters such as electronic data capture, image management and clinical trial management systems\nCreate a work environment that supports cross-functional team effectiveness and promotes efficiencies\nContribute to conference abstracts and peer reviewed publications with opportunity to present as applicable.\nRequirements\nQualifications:\nBachelor’s degree in a Life Sciences discipline required; Master’s degree or other advanced scientific/clinical qualification preferred.\nExceptional proficiency in professional English, with advanced medical and scientific writing skills, including development of clinical protocols, clinical study reports (CSRs), safety reports, annual regulatory reports, informed consent forms (ICFs), case report forms (CRFs), and other regulatory-compliant clinical trial documentation.\nDemonstrated experience authoring clinical study protocols and contributing to clinical sections of regulatory submissions, including PMA and/or 510(k) applications\nStrong presentation and communication skills, with experience delivering scientific and clinical information to investigators, key opinion leaders, clinical study teams, senior management, and at Clinical User Meetings.\nComprehensive knowledge of the medical device clinical trial lifecycle, from study concept and design through study execution, data analysis, CSR preparation, and regulatory submission support.\nIn-depth understanding of medical device clinical research, including operational, regulatory, and quality requirements, with thorough knowledge of Good Clinical Practice (GCP), FDA regulations, ISO 14155, and applicable global medical device regulations.\nSolid understanding of biostatistics and clinical data interpretation, with the ability to critically evaluate scientific literature and effectively communicate statistical outcomes in clinical and regulatory documents.\nStrong business acumen including presentation, verbal and written communication skills as well as negotiation, partnering, and collaboration without direct line management and including regular communications with senior clinical research physicians and scientists.\nMinimum of 5-6 years of progressive experience in clinical project management, including oversight of IDE, IND, Class III medical device, and/or drug-device combination product studies.\nExperience working directly with regulatory authorities, including FDA, notified bodies, and international regulatory bodies, supporting study submissions, approvals, and ongoing regulatory interactions\nProven ability to manage and oversee external clinical vendors, including contract research organizations (CROs), biostatistical consultants, core laboratories, data management providers, Clinical Events Committees and Data Safety Monitoring Boards (DSMBs).\nStrong knowledge of U.S., EU, Japan clinical trial regulations and processes; experience with international clinical research regulations and global study execution is highly desirable.\nRecognized subject matter expertise in regional clinical research regulations and compliance requirements.\nExcellent organizational, leadership, and stakeholder-management skills, with the ability to manage multiple complex projects in a fast-paced environment.\nWillingness and ability to travel as required, up to 35% of the time. Expected to travel to support investigator meetings and site initiation visits and support monitoring where needed.\nRecruiting Agencies: We do not accept unsolicited resumes from third parties for any of our open positions. To submit resumes for our jobs, a fully executed contract must be in place. We are not working with additional third party agencies at this time.","description_format":"text","description_chars":7618,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":true},"security_clearance":false,"languages":[{"language":"English","level":"Advanced (C1)","optional":false}]},"benefits":["Flexible schedule"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Surgical Instruments & Devices","Neurotech & Neuromodulation"],"lifecycle":[{"event":"open","at":"2026-10-26T12:04:42Z"}],"visa":[],"liveness":{"score":15,"band":"cold","label":"Long shot","p_open":1,"p_active":0.548,"p_room":0.28,"age_days":87,"expected_fill_days":22,"reasons":["conf:3","win:tail","crowd:"],"computed_at":"2026-11-01T06:10:25Z"},"pay":null,"html_url":"https://alion.io/job/insightec-sr-clinical-project-manager","json_url":"https://alion.io/job/insightec-sr-clinical-project-manager.json","meta":{"generated_at":"2026-11-01T20:10:29Z","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":31013,"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":49191},"rest":"https://alion.io/mcp/rest/get_company?id=49191"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Finsightec-sr-clinical-project-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%2Finsightec-sr-clinical-project-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%2Finsightec-sr-clinical-project-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/insightec-sr-clinical-project-manager\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Finsightec-sr-clinical-project-manager"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3271748}},{"tool":"search_jobs","arguments":{"company":"insightec.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3271748},"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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