{"id":3331513,"url":"https://alion.io/job/cyclepharma-senior-clinical-study-manager","title":"Senior Clinical Study Manager","company":{"id":720016,"name":"Cyclepharma","domain":"cyclepharma.com","url":"https://alion.io/company/cyclepharma","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"senior","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Cambridge, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":124000,"max_usd":217000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":356},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GCP","optional":false},{"name":"Good Clinical Practice","optional":true}],"status":"live","first_seen_at":"2026-10-27T08:29:03Z","employer_posted_date":"2026-10-27","last_verified_at":"2026-11-02T18:22:02Z","board_verified":true,"closed_at":null,"days_open":6,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":6},"description":"Senior Clinical Study Manager\nCycle Company: Cycle Pharmaceuticals Ltd\nPosition Summary: This full-time position is within the Research and Development department in our Cambridge office on a hybrid basis (minimum 3 days in the office).\nDo you want to make a meaningful difference in rare disease research?\nAt Cycle Pharmaceuticals, we’re expanding our Research and Development team and now recruiting for a hands-on Senior Clinical Study Manager to manage the operational delivery of Phase 3 clinical trials and Phase 4 post-approval studies across rare diseases, including studies undertaken to meet FDA post-marketing requirements and commitments.\nReporting to the Associate Director of Clinical Operations, you’ll take ownership of assigned studies from feasibility through to final clinical study report, ensuring delivery to agreed timelines, budgets and the highest standards of quality and regulatory compliance.\nThis is an opportunity to take on broad responsibility in a growing organisation, combining independent ownership, cross-functional collaboration and the opportunity to help advance research in rare diseases.\n\nOur Company\nAt Cycle, we believe that Every Single Patient Matters. This is at the heart of why we work and were looking for people to join our team who share our vision. We know that life-changing treatments need life-improving product support to match, because when you put the two together, great things can happen.\nOur growing portfolio now covers oncology, haematology, neurology and rare metabolic genetic conditions where we improve existing drugs, repurpose them for new uses and bring generics back to market. Using cutting-edge drug delivery technologies, we enhance the efficiency of treatments, offering patients greater freedom and choice.\nHeadquartered in Cambridge, UK, with a significant US presence, Cycle has scaled rapidly and was named one of the UK’s fastest-growing private companies by The Sunday Times (Sunday Times 100 2024 & Sunday Times 100 Tech 2025). If you want to know more about what we do then, why not check out our website and take a look at some of our patient stories: Patient Stories - Cycle Pharma\nWhat you’ll be doing in this role:\nDelivery of assigned Phase 3 clinical studies from feasibility through to database lock and final clinical study report, managing timelines, budgets, risks and quality.\nLead feasibility, country and site selection and develop recruitment and retention strategies tailored to small and pediatric populations, including patient-centric and decentralised approaches where appropriate.\nCoordinate clinical supply planning, randomisation, interim analyses, data monitoring committee activities and adaptive design decision points in collaboration with relevant teams.\nSupport with operational delivery of post-approval studies, including FDA post-marketing requirements and commitments, registries, observational studies, real-world evidence and open-label extensions, ensuring key regulatory milestones are met.\nSupport partner selection and contracting and vendor performance, monitor KPIs and study expenditure.\nEnsure studies comply with applicable GCP and regulatory requirements, oversee regulatory and ethics submissions, maintain the electronic Trial Master File (eTMF), and support audits, inspections and CAPA follow-up.\nBuild effective relationships with investigators, specialist centres and patient advocacy groups.\nProactively identify and mitigate operational risks and issues, escalating significant concerns and implementing appropriate corrective actions.\nContribute to departmental budget planning, resource forecasting and prioritisation to support clinical operations strategy and efficient study delivery.\nImprove clinical operations processes and procedures, share best practice, and mentor and support clinical operations colleagues, with potential for future line management responsibilities.\n\n The following skills and experience will be important in helping to set you up to succeed in this role:\nDegree in life sciences, pharmacy or a related discipline required; an advanced degree is preferred.\nSignificant clinical operations experience within the pharmaceutical, biotechnology or CRO industry, including operational leadership of Phase 3 clinical studies.\nExperience delivering studies in rare diseases, metabolic conditions or paediatric populations is strongly preferred.\nExperience managing post-approval studies, including FDA post-marketing requirement and commitment studies, open-label extensions, registries or observational studies, is strongly preferred.\nStrong experience working with US clinical sites and FDA requirements and familiarity with FDA Bioresearch Monitoring inspections is an advantage.\nProven ability to oversee CROs and vendors, manage study budgets and maintain high-quality electronic Trial Master Files (eTMFs).\nExperience with hybrid or decentralised trial approaches, including home nursing and direct-to-patient supply, is desirable.\nStrong working knowledge of ICH-GCP, including E6(R3), and applicable FDA, MHRA and EMA requirements.\nExcellent organisational, analytical and project management skills, with the ability to manage competing priorities, solve problems independently and drive delivery.\nStrong communication and stakeholder management skills, with the confidence to work effectively across cross-functional teams and external partners.\nProactive, hands-on and decisive, with a practical, solutions-focused mindset and a willingness to travel, including internationally to the US.\nWhat can we offer to you:\nIn addition to being part of a great team and doing things that will make a real difference to patients’ lives, you will enjoy all the benefits that brings:\nCompetitive salary based on experience\nA collaborative high performing work environment\nPerformance based bonus\nOpportunity to join a fast growing and ambitious business\nCompany pension scheme\n100% employer paid membership for Private Health Insurance\nLife and Critical Illness Insurance\nCorporate Gym membership\nRegular team building events and an agile working environment\nDiversity and Inclusion statement:\nAt Cycle Pharmaceuticals, we are committed to creating an inclusive, respectful, positive and diverse workplace. We do not discriminate on the basis of race, colour, religion, gender, age, disability, or any other protected characteristic. We actively support and embrace diversity, and we are working to build a team that reflects a wide range of backgrounds and perspectives.\nWe value your unique contributions and encourage you to join us in shaping a more inclusive future. If you require any reasonable adjustments - whether during the application process or in the workplace - we will be happy to support your needs. At Cycle, equality, inclusion, and respect are at the core of everything we do. We fully comply with all applicable employment laws, including those related to non-discrimination, work authorization, and employment eligibility verification.","description_format":"text","description_chars":7014,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":["Gym membership","Health insurance","Performance based bonus"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Rare Disease Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-27T12:15:23Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":5,"expected_fill_days":35,"reasons":["conf:0","win:early"],"computed_at":"2026-11-02T06:13:15Z"},"pay":null,"html_url":"https://alion.io/job/cyclepharma-senior-clinical-study-manager","json_url":"https://alion.io/job/cyclepharma-senior-clinical-study-manager.json","meta":{"generated_at":"2026-11-02T21:55:15Z","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":30714,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-03T00:00:00Z"}},"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":720016},"rest":"https://alion.io/mcp/rest/get_company?id=720016"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fcyclepharma-senior-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%2Fcyclepharma-senior-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%2Fcyclepharma-senior-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/cyclepharma-senior-clinical-study-manager\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fcyclepharma-senior-clinical-study-manager"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3331513}},{"tool":"search_jobs","arguments":{"company":"cyclepharma.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3331513},"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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