Senior Site Manager
Johnson & Johnson Innovative Medicine · Madrid
Descripcion del puesto
About the role
The Senior Site Manager is a mid‑level position responsible for acting as the primary liaison between the sponsor and investigational sites. The role ensures trial sites are inspection‑ready and compliant with the protocol, company SOPs, Good Clinical Practice (GCP) and applicable regulations from start‑up through site closure.
Key responsibilities
- Serve as the main local contact for assigned trial sites.
- Participate in site feasibility and qualification visits.
- Attend and support investigator meetings, preparing materials and presenting when required.
- Execute site initiation, monitoring (including remote), risk‑based monitoring, and close‑out activities in line with SOPs and work instructions.
- Collaborate with Local Trial Manager, Clinical Trial Assistant and Trial Delivery Leader to manage site activities.
- Identify and resolve monitoring issues promptly, contributing to continuous process improvement.
- Assist with site selection, subject recruitment planning, and mentor junior Site Managers.
Required profile
- 3‑5 years of experience in clinical site management.
- Ability to work independently with minimal supervision.
- Strong knowledge of GCP, SOPs and regulatory requirements.
- Excellent communication and stakeholder management skills.
- Willingness to travel to sites as needed.
Required skills
- Good Clinical Practice (GCP) compliance.
- Standard Operating Procedures (SOP) implementation.
- Risk‑based monitoring methodology.
- Site initiation and close‑out processes.
- Clinical trial protocol adherence.
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Johnson & Johnson Innovative Medicine
Madrid