{"id":3001973,"url":"https://alion.io/job/liquidia-clinical-study-manager","title":"Clinical Study Manager","company":{"id":3094098,"name":"Liquidia","domain":"liquidia.com","url":"https://alion.io/company/liquidia","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"HiBob","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":["United States"],"countries":["US"],"hiring_countries":["US"],"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":"2026-09-30T17:46:17Z","employer_posted_date":"2026-10-21","last_verified_at":"2026-10-24T22:47:51Z","board_verified":true,"closed_at":null,"days_open":24,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":24},"description":"Liquidia is deeply passionate and committed to the discovery, engineering, and development required to bring novel therapies to patients who need them most, and to the healthcare providers who care for them. Our current drive is toward improving the treatment of pulmonary hypertension (PH). We will continue to combine our proprietary, innovative PRINT® Technology with new and established medications, offering the potential for both better precision and improved clinical outcomes. Our team members include some of the industry’s top scientists, clinicians, business strategists, engineers, and pharmaceutical executives. We work together to help people lead longer, healthier, and happier lives.Job Summary\nThe Clinical Study Manager (CSM) will be part of the Clinical Operations Department, which is responsible for planning, executing, managing and closing studies associated with the company clinical development plans. The CSM is a proven leader in clinical development with study management experience in the pharmaceutical or device industry. The CSM provides leadership and support to members of the multidisciplinary program teams, internally and externally, and can successfully thrive in a virtual clinical model. The CSM reports to the Senior Director of Clinical Operations and may be based at Liquidia’s headquarters in Research Triangle Park, North Carolina, or remote.\nResponsibilities\nAct as a customer advocate throughout the clinical development project lifecycle.\nUnderstand and support global program goals including site identification and assessment, patient/subject recruitment, Key Opinion Leader (KOL) and Steering Committee development, and medical affairs support as required.\nIn collaboration with Program Leaders, lead the development of study specific protocols, consent forms, and other trial related materials (e.g., Study Monitoring Plan, Data Management Plans, Advertising Materials, etc.) as required.\nDevelop Requests for Proposals for vendors (CRO, Bioanalytical Labs, Central Safety Labs, Data Management groups, etc.) required to support clinical studies.\nAssist or lead the vetting of vendors and sites for study participation.\nManage the work of CROs and other vendors (Central Labs, Clinical Supply Distributors, etc.) as assigned to clinical studies.\nDevelop, manage, and track clinical trial budgets to include review and approval of all vendor and site payments. The CSM is also responsible for notifying management of anticipated change orders and/or budget adjustments proactively.\nFollow approved clinical study protocols and help the project leader maintain operational plans, which are consistent with strategic corporate and R&D objectives and support the project lead in primary accountability for the ongoing progress of those plans on assigned studies.\nCoordinate with Medical, CMC, PRINT Teams, and Quality Assurance management to identify goals and scope of clinical study projects.\nInitiate and train sites to the study protocol. Ensure proper site adherence to clinical research regulations.\nCollaboratively work with the project team and other CRO/vendor resources and timelines associated with all study start-up activities, including CRO/investigator agreements, central IRBs, database readiness, monitoring strategy, QA audit plan, and coordination of Clinical Safety Review Teams when applicable\nPlans for and manages all materials to support the appropriate execution of the clinical projects, including but not limited to distribution of documents, forms, supplies, equipment, and investigational product.\nReviews reports from study data systems which show progress of data collection, source document verification and query resolution. Reports untimely data entry to project lead.\nAssists with review of study data reports during the cleaning phase of a study (i.e. prior to interim analysis or database lock) and aligns with team on any issues needing escalation.\nEnsure maintenance of program files according to applicable regulations, guidelines, and corporate policy (e.g. GCPs and company SOPs)\nEnsure Trial Master File (TMF) is updated on an ongoing basis, and all documents are accounted for by completion of clinical study report.\nPerform, on a regular basis (e.g. quarterly), quality checks of the TMF.\nEnsure the development and maintenance of program-specific tracking systems to enable proper study management and monitoring activities, as required.\nEnsure operational and regulatory integrity of assigned studies and participate in FDA or other regulatory authority inspections, as needed.\nWork with the Director of Clinical Operations to ensure that internal program team members are trained appropriately on study conduct.\nServe as a liaison between vendors and internal team to ensure program specific information and ongoing updates are proactively communicated.\nDraft and send periodic study Newsletters.\nAttend off-site meetings and conferences, as needed.\nRequirements\nEducation and ExperienceBachelor’s with a minimum of five years of experience in clinical research, with at least two years of clinical project/study management. \nExperience qualifying & managing external vendors (e.g. CRO, Call Center, Central labs, etc.)\nExperience managing clinical project team personnel.\nExperience leading program operational teams through the start-up, study conduct, data management, and report writing of clinical studies.\nExperience reviewing and editing protocols and clinical study reports.\nDemonstrates knowledge of Good Clinical Practices and all applicable US regulations governing clinical research, as well as working knowledge of the FDA submission process.\nStrong understanding of clinical trial budget/resource forecasting and management.\nExcellent organization and communication skills, including experience dealing with decision makers, such as physicians, IRB members, and FDA staff.\nDemonstrates problem-solving and interpersonal skills. Must have a ‘can-do’ attitude and a strong desire to take ownership of many different projects.\nAbility to work independently and manage multiple timelines, while maintaining team focus\nDemonstrated ability to exercise judgment and determine appropriate action to a variety of problems of varying complexity.\nDemonstrated ability to manage multiple deadlines.\nKnowledge, Skills, and AbilitiesStrong desire to join a small company and work in a fast-paced environment.\nAbility to work with remote teams and to negotiate with external providers.\nMust be detail oriented, highly organized, reliable, and accurate.\nMust be a motivated self-starter, adaptable, and capable of working within a matrix environment.\nMust display sound judgment and discretion as well as problem solving abilities, especially within a team environment.\nStrong computer skills, including Microsoft programs and project management software.\nCompelling interpersonal verbal, written and presentation skills in communication with the internal and external customers.\nMust have the ability to accommodate international and domestic travel up to 30% at the request of the business.\nJob Benefits\nLiquidia offers a competitive compensation package as well as a comprehensive benefits package that includes Medical, Dental, Vision, STD, LTD, 401(k) Savings Retirement Plan, ESPP, and more!Liquidia is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions of this position.\nRecruiting Agencies, Please Note:\nLiquidia will not accept unsolicited assistance from recruiting/search agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by recruiting or search agencies to any employee at Liquidia via email, the Internet or in any form and/or method without a valid written search/recruitment agreement in place for this position will be deemed the sole property of Liquidia. No fee will be paid in the event the candidate is hired by Liquidia as a result of the referral or through other means.","description_format":"text","description_chars":8240,"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":["Retirement plans"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":[],"lifecycle":[{"event":"open","at":"2026-10-21T12:29:20Z"}],"visa":[],"liveness":{"score":74,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.817,"p_room":0.9,"age_days":23,"expected_fill_days":35,"reasons":["conf:3","win:mid"],"computed_at":"2026-10-24T06:02:35Z"},"pay":null,"html_url":"https://alion.io/job/liquidia-clinical-study-manager","json_url":"https://alion.io/job/liquidia-clinical-study-manager.json","meta":{"generated_at":"2026-10-25T02:11:18Z","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":3288,"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":3094098},"rest":"https://alion.io/mcp/rest/get_company?id=3094098"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fliquidia-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%2Fliquidia-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%2Fliquidia-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/liquidia-clinical-study-manager\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fliquidia-clinical-study-manager"}]}