{"id":2716484,"url":"https://alion.io/job/bayer-clinical-operations-manager-2-com2","title":"Clinical Operations Manager 2 (COM2)","company":{"id":671164,"name":"Bayer","domain":"bayer.com","url":"https://alion.io/company/bayer-7","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SuccessFactors","truth_index":null},"role":"Management","role_family":"Management","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Barcelona, Spain"],"countries":["ES"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":45000,"max_usd":85000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":9},"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GCP","optional":false}],"status":"live","first_seen_at":"2026-10-16T13:56:11Z","employer_posted_date":"2026-10-16","last_verified_at":"2026-10-17T14:05:09Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"Clinical Operations Manager 2 (COM2)\n\nThe COM 2 is a regional role that provides expertise across all aspects of clinical site management and/ or study management for assigned Phase I - IV studies. The COM 2 operates in line with Good Clinical Practices (ICH-GCP), applicable regulatory and legal requirements and Bayer’s standard operating procedures.\nThe COM 2 may be assigned work packages in areas of study start-up, site management and study management on a regional level. Either one or a combination of these work packages may be allocated to the position holder according to expertise, skill set and capacity requirements in a flexible way. The COM 2 must acquire knowledge and adequate training for work packages assigned and become proficient in independently executing assigned responsibilities.\nSTUDY MANAGEMENT\nLead and oversee all operational aspects of site management on a regional or study level from protocol feasibility to study archive.\nServe as the representative for site management on the core study team. \nContribute to the development of the protocol, study overview, monitoring strategy and Risk Based Quality Management with regards to monitoring and operational aspects.\nResponsible and accountable for developing the monitoring plan and the study-specific training plan.\nKey contributor in the development of recruitment and retention strategies and tools. \nAct as key study contact for assigned countries. Responsible for overall deliverables regarding timelines, budget, and quality in assigned countries.\nEnsure participating country commitment aligns with study commitments.\nProvide the information required to effectively monitor and manage study activities, ensuring all relevant IT systems are updated with precise and current data.\nOversee monitoring activities and ensure sponsor oversight through monitoring report review and co-monitoring visits.\nSITE MANAGEMENT\nAct as primary contact for investigational sites.\nVerify site qualification, ensure the Investigator, and site staff meet all aspects of study delivery and commitments from site selection through close out.\nTrain the Investigator and site staff on study protocol, relevant systems and operational aspects of study conduct.\nMonitor trial conduct in compliance with the study protocol, ICH-GCP and applicable regulatory requirements on time and quality. Ensure completeness of the Investigator Site File.\nPrepare and conduct onsite and/or remote monitoring activities according to monitoring plan, including complete reporting and follow up.\nCLINICAL CUSTOMER ENGAGEMENT\nCultivate and sustain customer relations with clinical trial sites, ensure effective communication, drive fit for purpose processes and work towards enhancing overall site satisfaction and engagement.\nEstablish and develop strong professional relationships with clinical investigators to expand/ maintain clinical research partnership opportunities.\nCross functional collaboration to ensure alignment of priorities and deliver the portfolio.\nInfluence and challenge internal and external factors to improve clinical research delivery.\nSTUDY START-UP\nLead study start-up activities in collaboration with local team.\nProvide input on site activation strategy. \nCollect and perform quality review of essential documents on country level such as IRB/IEC approvals, financial disclosure, CVs/medical licenses, etc.\nCompile and submit submission dossier (country dependent).\nObtain any required approvals for relevant site documents (e.g., informed consent, financial disclosures).\nPrepare and distribute site start up documentation including Investigator Site File.\nEnsure timely filing of study documents at country and site level in Trial Master File (TMF).\nEnsure awareness of related local regulations and support maintenance of country intelligence.\nProvide study status monitoring and systems support (e.g. act as technical expert)\nCoordinate site and vendor payments.\nQUALITY\nProactively identify and communicate issues, taking appropriate action to prevent the recurrence of identified deviations. Ensure timely and comprehensive resolution of issues that may affectcompliance or the quality of study related activities or data.\nMaintain corrective action and preventative action plans (CAPAs) at country level.\nContribute to the preparation, conduct, and follow-up of Site Audits and Regulatory Inspections to ensure a successful outcome.\nOversee completeness of country/site level eTMF and conduct QC for accuracy, completeness, and adherence to ICH/GCP and Bayer QSDs.\nSKILLS & QUALIFICATIONS:\nHealthcare related Bachelor’s Degree or equivalent with minimum 4 years of monitoring and site management experience. Or have a combination of education and minimum 8 years of monitoring and site management experience. Experience in Spain. Languages: Effective written and verbal English and Spanish communication skills. Fundamental project management skills, Decision making, Issue resolution\nHome based in Spain\nLocation: Spain\n\nApplication Period:\n15 días\nReference Code:\n891581\n\nDivision:\nPharmaceuticals\nLocation:\nSpain : Cataluña : Barcelona\n\nFunctional Area:\nClinical Development & Operations\nPosition Grade:\nVS 1.2\n\nEmployment Type:\nRegular \nWork Time:\nRegular\n\nContact Us\n\nAddress\nTelephone\nE-Mail\n\nAv. Baix Llobregat, 3, 08970 Sant Joan Despí,\nBarcelona, Espanya\n\n+34 93 495 69 99\n\n ","description_format":"text","description_chars":5393,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":true},"security_clearance":false,"languages":[{"language":"Spanish","level":"Upper-Intermediate (B2)","optional":false},{"language":"English","level":"Upper-Intermediate (B2)","optional":false}]},"benefits":[],"hiring_locations":[{"name":"Spain","iso":"ES","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Crop Protection","OTC & Consumer Health Products"],"lifecycle":[{"event":"open","at":"2026-10-16T13:56:11Z"}],"visa":[],"liveness":{"score":90,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.903,"p_room":1,"age_days":0,"expected_fill_days":11,"reasons":["conf:0","velocity","win:early","comp:brand"],"computed_at":"2026-10-17T05:46:00Z"},"pay":null,"html_url":"https://alion.io/job/bayer-clinical-operations-manager-2-com2","json_url":"https://alion.io/job/bayer-clinical-operations-manager-2-com2.json","meta":{"generated_at":"2026-10-17T22:25:03Z","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":320,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-18T00:00:00Z"}},"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":671164},"rest":"https://alion.io/mcp/rest/get_company?id=671164"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fbayer-clinical-operations-manager-2-com2"},{"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%2Fbayer-clinical-operations-manager-2-com2"},{"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%2Fbayer-clinical-operations-manager-2-com2"},{"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/bayer-clinical-operations-manager-2-com2\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fbayer-clinical-operations-manager-2-com2"}]}