{"id":771014,"url":"https://alion.io/job/catalystcr-project-manager","title":"Project Manager","company":{"id":670214,"name":"Worldwide Clinical Trials","domain":"catalystcr.com","url":"https://alion.io/company/catalystcr","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Rippling","truth_index":{"grade":"B","score":75,"open_postings":3,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-10-29T05:49:05Z"}},"role":"Management","role_family":"Management","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["United Kingdom"],"countries":["GB"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":73000,"max_usd":124000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":111},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GCP","optional":false},{"name":"Mandiant capa","optional":false},{"name":"Microsoft Office","optional":true}],"status":"live","first_seen_at":"2026-03-26T21:27:27Z","employer_posted_date":"2026-03-26","last_verified_at":"2026-10-30T01:01:19Z","board_verified":true,"closed_at":null,"days_open":217,"trust":{"level":"stale","repost_count":0,"flags":["stale"],"days_open":216},"description":"Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology,a full-service oncology CRO, and multi-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com.\n As a Project Manager you are a key member of the Development Operations, Project Management Team. You are accountable for achieving successful delivery of clinical trial team activities at the trial/program level by meeting contractually agreed sponsor and regulatory requirements according to Scope of Work (SOW) and agreed upon timelines. You will lead and direct cross functional teams and understand/manage sponsor expectations. You will proactively identify, resolve/mitigate, and escalate risks and/or issues.\nPosition Responsibilities/Accountabilities:\nResponsible for planning, tracking and delivery of efficient and high-quality trial execution of all operational aspects of assigned clinical trials/programs (can be more than one) from protocol inception through Clinical Study Report and trial close out.\nResponsible to manage and drive the SOW consistent with the targeted timelines and budget for the assigned clinical trials/programs.\nResponsible for communication to the sponsor with strict attention to budget and timeline estimates for deliverables and timely notification of changes to SOW and timelines.\nResponsible for timely communications to the sponsor on all aspects of the study with a priority on communicating any patient safety issues.\nIn collaboration with the trial/program team and all stakeholders ensures the completion of all project deliverables from contract signature to delivery of final clinical study report and project close out complying with ICH GCP requirements.\nResponsible to manage study vendors, patient enrollment and liaise with investigators and study sites.\nLead cross-functional teams while understanding and managing client expectations. \nResponsible for working with the sponsor, subcontractors and Catalyst assigned project team members to manage resources (internal and external) to meet contracted project timeline and sponsor expectations.\nResponsible to proactively identify, resolve/mitigate, and escalate risks or issues when necessary and proactively communicate to the project team any issue that may negatively impact the overall project, seeking a collaborative resolution.\nContinually look for methods to improve the overall collaboration, efficiency, and excellence with which the deliverables are achieved.\nPerform project status tracking and reporting including participation in the monthly project review with the ELT.\nAccountable for the overall integration and communication of the study parameters to all stakeholders/partners (sub-contractors, strategic partners, internal partners, and Sponsor representatives) to ensure the execution of the work product.\nEnsure effective project plans (i.e., Clinical Monitoring Plan, Communication Plan, Project Management Plan, Vendor Oversight Plan, Recruitment Plan) are developed and in place and optimal for the trial as per SOW and company Standard Operating Procedures (SOPs). \nWork proactively with the clinical trial team to set priorities in accordance with applicable project plan, company SOP and procedures, International Conference on Harmonization-Good Clinical Practice (ICH/GCP) guidelines and regulatory requirements.\nResponsible for oversight of the Clinical Monitoring Plan to ensure a consistent approach to monitoring is maintained throughout the study.\nPer SOW collaborate with internal safety team member or Safety Vendor to develop Safety Management Plan and ensure the internal and extended team members are trained on the plan. \nProactively report project resource needs to management (overage as well as shortage).\nContribute to the development of site initiation presentations and in collaboration with the Clinical Research Associate (CRA) and sponsor deliver to sites for initiation purposes.\nProvide project/trial level input and coordination of tasks supporting the following deliverables: feasibility analysis, recruitment projections, data collection status, data cleaning progress and strategy, data lock tracking and overall reporting of deliverable timelines.\nDevelops and revises trial and site recruitment strategies/plan to support achieving the recruitment goal as driven by project milestones.\nCollaborate with Central Site Services in the development of the templates for the investigator contract and budget, and investigator Grant payments process.\nTeam with cross functional team members (i.e., Data Management (DM), Clinical Science (CS) and Biostats) in protocol deconstructioneCRF (Electronic Case Report Form) development, the development and review of the data management plan, edit specifications, eCRF completion guidelines, diaries, questionnaires, and data screens.\nThroughout the course of the project, monitor and QC the electronic Trial Master File (eTMF) to ensure that the required trial documentation is filed per the TMF reference model.\nAt study close out responsible for oversight and transfer of a quality eTMF to the sponsor.\nCollaborate with internal team, sponsor, medical monitor, and partners to develop agenda and content of the project team meetings.\nLead the project, site, internal and vendor meetings and ensure meeting minutes and action items are captured, distributed to all team members, sponsor, and management. \nIn collaboration with CS and DM review and identify study data for trends (per company process) and in collaboration with the internal team develop a plan (retraining of sites etc.) to address any issues or concerns with the data collection/data entry.\nParticipate as needed in data review meetings in collaboration with DM, CS and Biostats, internally and with the sponsor to review data for trends or issues and develop an action plan to address any questions or concerns. \nMonitor the quality of vendor deliverables, address any issues with the appropriate team members and identify opportunities to improve training, execution, and quality across the team. Responsible for oversight of any changes to the study because of a protocol amendment as per the SOW. This includes ensuring study related documents (i.e., Amendment, ICFs, manuals, plans, eCRF, eCRF completion guidelines and contracts) are updated and distributed/communicated to the internal and external team and vendors in a timely manner. \nResponsible for oversight of Corrective and Preventative Action Plan (CAPA) process implementation as needed for assigned trials. Collaborates with cross functional teams, Clinical Operations Management and Quality Management on CAPA plan, process, and implementation. \nResponsible to review and provide input to corrective and preventative actions for Internal Quality Review (IQR) findings for assigned studies and works with Clinical Operations Management to address findings.\nFacilitate and assist Medical Writing in the development of the Clinical Study Reports (CSRs).\nMaintain proficiency to current ICH and GCP regulations, guidelines, and white papers as they apply to areas of study.\nPosition Qualification Requirements:\nEducation: Minimum of a BS/BA in a biomedical discipline or equivalent education/training is required.\nExperience: Minimum of 5 years’ experience with clinical research methodology and product development activities (IND filing, study design, monitoring, study coordination, data management, data analysis, NDA submissions) and prior project management or project lead coordination experience.\n\nRequired Certifications: N/A\nRequired Skills:\nDemonstrated proficiency in communicating with and motivating multiple partners/vendors/outsource partners.\nExceptional attention to detail and timelines.\nDemonstrated track record in leading successful teams to achieve aggressive timelines using creative problem-solving techniques.\nCollaborative leadership style.\nPreferred experience in bid defense process\nAbility and willingness to travel as needed.\nProficient with Microsoft Office Suite.\nExcellent written and oral communication skills.\nStrong organizational, problem-solving, and analytical skills.\nVersatility, flexibility, and a willingness to work within constantly changing priorities.\nProven ability to handle multiple projects and meet deadlines.\nAbility to deal effectively with a diversity of individuals at all organizational levels.\nCommitment to excellence and high standards.\nAbility to work independently and as a member of various teams and committees.\nGood judgement with the ability to make timely and sound decisions.","description_format":"text","description_chars":8792,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Clinical Trial Services (CRO)"],"lifecycle":[{"event":"open","at":"2026-09-11T21:36:38Z"}],"visa":[],"liveness":{"score":7,"band":"cold","label":"Long shot","p_open":1,"p_active":0.232,"p_room":0.28,"age_days":216,"expected_fill_days":29,"reasons":["conf:3","win:tail","crowd:"],"computed_at":"2026-10-29T05:49:05Z"},"pay":null,"html_url":"https://alion.io/job/catalystcr-project-manager","json_url":"https://alion.io/job/catalystcr-project-manager.json","meta":{"generated_at":"2026-10-30T02:10:37Z","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":2878,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-31T00:00:00Z"}},"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":670214},"rest":"https://alion.io/mcp/rest/get_company?id=670214"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fcatalystcr-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%2Fcatalystcr-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%2Fcatalystcr-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/catalystcr-project-manager\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fcatalystcr-project-manager"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":771014}},{"tool":"search_jobs","arguments":{"company":"catalystcr.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":771014},"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. Docs: https://alion.io/developers"}}