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Senior Clinical Project Manager

2 months ago
Argentina, Brazil, United States
Full-time
Senior
Project Manager
Project and Program Management
Apply Now
EDETEK

EDETEK

EDETEK Inc. is a premier provider of digital clinical trial systems, offering innovative solutions to streamline data collection and analysis for pharmaceutical and biotech companies.

Internet Software & Services
51-250
Founded 2009
View All Jobs 7

Description

  • Lead clinical study activities from startup through closeout in line with protocol, sponsor requirements, scope, budget, SOPs, GCP, and regulations.
  • Serve as the primary operational point of contact for assigned sponsors and maintain strong sponsor relationships.
  • Develop and manage study timelines, project plans, status reports, action logs, and risk registers.
  • Coordinate cross-functional teams across clinical operations, data management, biostatistics, statistical programming, medical writing, safety, regulatory, and technology functions.
  • Facilitate internal project meetings, sponsor meetings, and governance discussions, and ensure timely follow-up on action items.
  • Monitor study progress, identify operational risks and quality issues, and escalate or mitigate timeline concerns as needed.
  • Oversee vendors and external partners to ensure deliverables meet quality standards and project timelines.
  • Support budget tracking, change order review, scope management, and resource planning.
  • Ensure inspection readiness and support sponsor audits, internal audits, and regulatory inspections.
  • Lead or support Data Monitoring Committee activities, including planning, logistics, documentation, and follow-up tracking.

Requirements

  • Bachelor’s degree in life sciences, nursing, pharmacy, public health, or a related field is required; an advanced degree is preferred.
  • Minimum of 7 years of clinical project management experience in the pharmaceutical, biotechnology, medical device, or CRO industry.
  • Strong experience working in a CRO environment with sponsor-facing project responsibilities.
  • Demonstrated experience coordinating or supporting DMC or IDMC activities in clinical trials.
  • Strong understanding of ICH-GCP, clinical trial operations, and applicable regulatory requirements.
  • Proven ability to manage multiple projects, priorities, and stakeholders in a fast-paced environment.
  • Experience with study risk management, vendor oversight, and issue escalation.
  • Proficiency in Microsoft Office and familiarity with clinical systems such as CTMS, EDC, eTMF, and related project tracking tools.
  • Ability to work effectively with global teams across multiple time zones.
  • Occasional travel may be required based on project or client needs.
  • Experience in oncology, rare disease, CNS, immunology, or other complex therapeutic areas is preferred.
  • Experience managing global or multi-regional clinical trials is preferred.
  • Familiarity with biometrics-related deliverables, including interim analysis support and reporting packages for DMC meetings, is preferred.
  • Experience with decentralized trial tools, eClinical platforms, or integrated technology-enabled clinical solutions is preferred.

Benefits

  • Remote position open to candidates in the United States, Argentina, and Brazil.
  • Comprehensive medical, vision, and dental insurance plans for U.S. employees.
  • Paid vacation time and sick days.
  • Corporate holidays annually.
  • Participation in a 401(k) plan.
  • Discount and perks programs covering AAA, wholesale, insurance, prescriptions, fitness, pets, and entertainment.
  • Health Advocate and Employee Assistance Program.
  • Competitive benefits that vary by country.

Interested in this position?

Apply directly on the company website

Apply Now

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