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Alcedis - a HUMA company
Alcedis - a HUMA company
51 – 200 Angajați
Asistență medicalăConsultanțăLogistică
Alcedis - a HUMA company este o organizație de cercetare contractuală specializată în cercetare clinică susținută de tehnologie pentru dezvoltarea produselor biotehnologice și farmaceutice. Echipa sa combină operațiunile clinice cu managementul proiectelor, managementul datelor, monitorizarea, afacerile de reglementare, bio-statistica, redactarea medicală și farmacovigilența. Alcedis dezvoltă, de asemenea, instrumente digitale pentru cercetare, inclusiv formulare electronice adaptive de raportare a cazurilor, aplicații mobile, integrări și capabilități de știința datelor și inteligență artificială, sprijinind studiile de la etapele timpurii de dezvoltare până la aprobarea de reglementare și generarea de dovezi din lumea reală.
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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.

USStatele Unite ale Americii
80.000 $ – 110.000 $ / an
RemoteNormă întreagăNivel mediuSeniorLimbă Obligatorie: englezăOperațiuni clinice

Descriere

  • 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

Cerințe

  • 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

Beneficii

  • 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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