Alcedis - a HUMA company
Alcedis - a HUMA company
Alcedis - a HUMA company एक कॉन्ट्रैक्ट रिसर्च ऑर्गनाइज़ेशन है, जो बायोटेक और फार्मास्यूटिकल विकास के लिए प्रौद्योगिकी-सक्षम क्लिनिकल रिसर्च में विशेषज्ञता रखता है। इसकी टीम क्लिनिकल ऑपरेशंस को प्रोजेक्ट मैनेजमेंट, डेटा मैनेजमेंट, मॉनिटरिंग, नियामक मामलों, बायोस्टैटिस्टिक्स, मेडिकल राइटिंग और फार्माकोविजिलेंस के साथ जोड़ती है। Alcedis डिजिटल रिसर्च टूल भी विकसित करता है, जिनमें अनुकूली इलेक्ट्रॉनिक केस रिपोर्ट फ़ॉर्म, मोबाइल एप्लिकेशन, इंटीग्रेशन तथा डेटा साइंस और एआई क्षमताएँ शामिल हैं। ये सेवाएँ प्रारंभिक विकास से लेकर नियामक अनुमोदन और वास्तविक दुनिया के साक्ष्य तक अध्ययनों का समर्थन करती हैं।

Clinical Project Manager – Clinical Research and IT

Manage U.S. clinical research projects and digital trial technologies for Alcedis, a contract research organization. Responsibilities include regulatory submissions, budgets, site coordination, technology oversight, and collaboration with international teams.

विवरण

  • Direct clinical trial planning and delivery from study start-up through ongoing management
  • Maintain essential study records and documentation, including TMF and ISF
  • Track milestones and keep study execution aligned with the approved Project Plan and objectives
  • Manage project budgets, financial controls, and reporting to the functional unit head
  • Prepare and oversee submissions to the FDA, IRBs, and other applicable authorities, including INDs, CTAs, amendments, and safety reports
  • Coordinate cross-functional project teams working across the United States and Germany
  • Oversee the work and deliverables of subcontractors
  • Manage clinical trial technologies and digital platforms such as ePRO, eCOA, and eCRF
  • Help manage supporting IT services and verify that solutions meet the needs of U.S. clients and participants
  • Work with technical teams to troubleshoot issues, deploy updates, and improve workflows
  • Create and implement processes, SOPs, work instructions, and standardized records
  • Coordinate trial sites through communication, training, document shipment and tracking, and payment processing
  • Travel may be required for project-related activities

आवश्यकताएँ

  • Bachelor’s degree in natural sciences, a related discipline, or an equivalent qualification; an advanced degree is preferred
  • 3–5+ years of experience working as a Clinical Project Manager in clinical research
  • Previous experience in a contract research organization is required
  • Demonstrated ability to independently manage and complete IRB or ethics committee submissions
  • Working knowledge of data privacy, data protection, and clinical research standards, including The Belmont Report, HIPAA, and FDA 21 CFR Part 11
  • Knowledge of GDPR is an advantage
  • Comfort working independently with limited structure and without local colleagues or on-site management
  • Experience using electronic data systems and databases
  • Strong working knowledge of Microsoft Office
  • Ability to work confidently with clinical research technology and digital platforms
  • Strong interpersonal, communication, and organizational capabilities
  • Effective collaborator across functions, teams, and international boundaries
  • Fluent written and spoken English
  • Must reside in the Eastern or Central United States

लाभ

  • 15 days of paid vacation annually
  • 6 paid sick days annually
  • Health, dental, and vision coverage for employees and dependents
  • Employer-provided life insurance
  • Health Savings Account (HSA)
  • 401(k) plan without an employer match
  • Growth-focused workplace oriented toward the future
  • Challenging projects designed to have meaningful impact
  • Open, collaborative culture supported by a flat organizational structure
  • Dedicated and supportive team environment
  • Varied responsibilities with autonomy over project ownership
  • Flexible hours that support work-life balance

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