Site Manager (0,5fte)
Adaugat: Ieri
Billennium
Site Manager (0,5fte)
Adaugat: Ieri
Billennium
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We are seeking a proactive and detail-oriented Site Manager to support clinical trial activities remotely. This role combines responsibilities in site management, remote monitoring, and study start-up activities, including contract negotiation support. The successful candidate will ensure that investigative sites conduct clinical studies in compliance with protocols, applicable regulations, and sponsor requirements.
Your skills & experience
- Bachelor’s degree in Life Sciences, Healthcare, or related field (Law degree is a strong advantage)
- Minimum of 2 years of experience in clinical research (e.g., CRA, Site Coordinator, Start-up Specialist)
- Experience in study start-up activities and/or contract negotiations is highly preferred
- Strong understanding of ICH-GCP guidelines and clinical research regulations
- Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS)
- Fluency in English (written and spoken)
Nice to have:
- Legal background or experience in contract negotiation within clinical trials
- Previous experience supporting clinical trial start-up in Poland
- Familiarity with risk-based monitoring and KPI tracking
Your role
- Act as the primary point of contact between the sponsor and investigative sites
- Perform remote site management and monitoring activities across assigned studies
- Support study start-up activities, including feasibility, site activation, and contract negotiation processes
- Collaborate with field CRAs and cross-functional teams to ensure efficient site performance
- Review and ensure the quality and integrity of clinical data (eCRF review, query management)
- Ensure timely data entry and resolve data discrepancies with sites
- Provide training and ongoing support to site staff
- Support patient recruitment and retention strategies
- Track and manage site performance metrics (KPIs) and study risks
- Assist with audit readiness and regulatory compliance
- Maintain accurate documentation of all site communications and activities
- Support study close-out and database lock activities
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