ERGOMED
ERGOMED
ERGOMED este un grup global de servicii medicale care sprijină companiile de biotehnologie și farmaceutice pe parcursul întregului ciclu de dezvoltare a medicamentelor. Activitățile sale includ Ergomed Clinical Research, PrimeVigilance și ADAMAS Consulting, oferind servicii de organizație de cercetare clinică, asistență în farmacovigilență și informații medicale, precum și audituri GxP. Compania lucrează la studii clinice în oncologie, boli rare și alte domenii complexe, având operațiuni în aproximativ 100 de țări.

ERGOMED Remote Site Manager, Clinical Research (Germany)

ERGOMED is hiring a remote Site Manager in Germany to support rare disease and oncology clinical trials. The role covers site staff training, study procedures, recruitment, supplies, reporting, and GCP compliance.

Descriere

  • Coordinate the delivery of clinical studies
  • Provide patient-focused support to sites in line with study-specific management plans
  • Train and oversee site staff handling logistically or technically complex study procedures
  • Ensure studies are conducted, documented, and reported in accordance with protocols, SOPs, ICH GCP, and regulatory requirements
  • Serve as the main contact for Study Site Coordinators and Research Nurses
  • Complete Site Manager training
  • Deliver ongoing training, guidance, support, and supervision to Study Site Coordinators
  • Support patient recruitment and retention planning while monitoring recruitment activity
  • Manage inventories of investigational medicinal products and clinical trial supplies
  • Coordinate logistics for sample shipments
  • Escalate site issues to the LSM, CRA, CTM, or PM
  • Build effective working relationships with site coordinators, research nurses, investigators, and sub-investigators
  • Join internal team teleconferences and site management meetings
  • Prepare Site Management Visit reports following onsite or remote visits
  • File visit reports, telephone contact reports, and correspondence in the eTMF
  • Support patient travel expense administration, calculation sheets, and site invoicing

Cerințe

  • Degree-level education, preferably in medicine or public health, or equivalent relevant experience
  • Prior experience in site management or site support activities
  • Fluency in English and German
  • Strong communication skills
  • Strong organisational skills
  • Experience working with clinical study protocols, Ergomed SOPs, ICH GCP, and applicable regulations
  • Ability to support Study Site Coordinators, Research Nurses, investigators, and sub-investigators
  • Ability to manage investigational medicinal product and clinical trial supply inventories
  • Ability to prepare site management visit reports and maintain eTMF records
  • Ability to support patient travel expense administration and site invoicing

Beneficii

  • Flexible remote working arrangements
  • Work-life balance
  • Collaborative international team environment
  • Career development opportunities
  • Autonomy and trusted ownership
  • Supportive workplace culture
  • Opportunity to contribute to clinical research that helps bring safe and effective pharmaceutical treatments to patients

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