{"id":811510,"url":"https://alion.io/job/edetek-senior-clinical-project-manager","title":"Senior Clinical Project Manager","company":{"id":674017,"name":"EDETEK","domain":"edetek.com","url":"https://alion.io/company/edetek","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workable","truth_index":null},"role":"Management","role_family":"Management","seniority":"senior","employment_type":"contractor","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"posting_text","remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":[],"countries":[],"hiring_countries":["AR","BR","MX"],"hiring_countries_total":3,"salary":null,"salary_estimate":{"min_usd":42000,"max_usd":94000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":6904},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GCP","optional":false},{"name":"Good Clinical Practice","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-07-10T00:00:00Z","employer_posted_date":"2026-07-10","last_verified_at":"2026-11-12T06:34:50Z","board_verified":true,"closed_at":null,"days_open":125,"trust":{"level":"ok","repost_count":0,"flags":[],"days_open":125},"description":"EDETEK is seeking an experienced and highly motivated Senior Clinical Project Manager to lead the planning, execution, and oversight of clinical trials for pharmaceutical, biotechnology, and medical device clients. This role is responsible for cross-functional project leadership from study startup through closeout, with a strong focus on timeline management, sponsor communication, risk management, vendor oversight, and quality delivery.\nThe ideal candidate will bring solid experience in a CRO environment and hands-on experience coordinating Data Monitoring Committee (DMC) activities, including meeting planning, deliverable readiness, communication management, and follow-up tracking. This individual must be able to manage multiple stakeholders, work effectively in a matrixed environment, and ensure studies are delivered on time, within scope, and in compliance with applicable regulations and company procedures.\nEssential Functions and Responsibilities\nLead and manage clinical study activities from startup through closeout in accordance with protocol, sponsor requirements, project scope, budget, SOPs, GCP, and applicable regulations.\nServe as the primary operational point of contact for assigned sponsors and maintain strong, professional sponsor relationships.\nDevelop, maintain, and manage study timelines, project plans, status reports, action logs, and risk registers.\nCoordinate cross-functional teams, including clinical operations, data management, biostatistics, statistical programming, medical writing, safety, regulatory, and technology teams.\nFacilitate internal project meetings, sponsor meetings, and governance discussions, and ensure timely follow-up on action items.\nMonitor study progress and identify operational risks, quality concerns, and timeline issues, with proactive mitigation and escalation as needed.\nOversee study vendors and external partners to ensure deliverables are completed with high quality and in accordance with project timelines and expectations.\nSupport budget tracking, change order review, scope management, and resource planning in collaboration with leadership and other stakeholders.\nEnsure inspection readiness and support sponsor audits, internal audits, and regulatory inspections, as applicable.\nPromote effective communication and collaboration across global teams and functions.\nDMC Coordination Responsibilities\nLead or support the coordination of Data Monitoring Committee activities for assigned studies.\nDevelop and maintain DMC timelines, meeting schedules, communication plans, and tracking tools.\nCoordinate preparation of DMC deliverables, including data cuts, tables, listings, figures, reports, presentations, and meeting materials, in collaboration with biometrics and other relevant functions.\nMonitor readiness of DMC packages and ensure timely collection, review, quality control, and distribution of meeting materials.\nOrganize DMC meetings, including logistics, document flow, agenda management, attendance coordination, and follow-up activities.\nFacilitate communication among sponsors, DMC members, independent statisticians, and internal study teams while maintaining required confidentiality and blinding controls.\nEnsure DMC activities are conducted in accordance with the DMC charter, study protocol, sponsor requirements, and applicable procedures.\nMaintain complete and accurate documentation of DMC decisions, recommendations, meeting minutes, and action items.\nRequirements\nBachelor’s degree in life sciences, nursing, pharmacy, public health, or a related field required. Advanced degree preferred.\nMinimum of 7 years of clinical project management experience in the pharmaceutical, biotechnology, medical device, or CRO industry.\nStrong experience working in a CRO environment with sponsor-facing project responsibilities.\nDemonstrated experience coordinating or supporting DMC or IDMC activities in clinical trials.\nStrong understanding of ICH-GCP, clinical trial operations, and applicable regulatory requirements.\nProven ability to manage multiple projects, priorities, and stakeholders in a fast-paced environment.\nExperience with study risk management, vendor oversight, and issue escalation.\nStrong organizational, analytical, and problem-solving skills.\nExcellent verbal and written communication skills.\nProficiency in Microsoft Office and familiarity with clinical systems such as CTMS, EDC, eTMF, and related project tracking tools.\nAbility to work effectively with global teams across multiple time zones.\nOccasional travel may be required based on project or client needs.\nPreferred Qualifications\nExperience in oncology, rare disease, CNS, immunology, or other complex therapeutic areas.\nExperience managing global or multi-regional clinical trials.\nFamiliarity with biometrics-related deliverables, including data review, interim analysis support, and reporting packages for DMC meetings.\nExperience working with decentralized trial tools, eClinical platforms, or integrated technology-enabled clinical solutions.\nCore Competencies\nClinical project leadership\nSponsor relationship management\nDMC coordination\nCRO operations\nVendor oversight\nRisk identification and mitigation\nCross-functional collaboration\nTimeline and budget management\nQuality and compliance focus\nDecision-making and accountability\nBenefits\nBenefits vary by country, but remain competitive. Below is a sample of the benefits offered to U.S. employees.\nChoice of comprehensive Medical, Vision and Dental Insurance plans\nPaid vacation time and sick days\nCorporate holidays annually\nParticipation in the 401K Plan\nComprehensive perks and discount programs for AAA, wholesale, insurance, Rx, fitness, pets, entertainment, etc.\nHealth Advocate and Employee Assistance Program\nLocation:\nThis is a remote position, and we are open to candidates based in the United States, Argentina, and Brazil.\nEqual Opportunity Employer Statement\nEDETEK is an equal opportunity employer and does not unlawfully discriminate against employees or applicants for employment on the basis of an individual’s race, color, religion, creed, sex, national origin, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. 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