Senior Site Manager

hace 1 semana

Madrid, Madrid, España Johnson & Johnson A tiempo completo

Senior Site Manager, Early Development & Clinical Pharmacology:

We are looking for a Senior Site Manager, Early Development & Clinical Pharmacology (ED&CP) to serve as the primary contact point between the Sponsor and the Investigational Site for the conduct of complex early development and/or clinical pharmacology studies.

In other organisations, the Site Manager may be known as Clinical Research Associate or Monitor. The head office location is in Madrid, Spain, and this position is home-based.


As a Senior Site Manager, you will be responsible for maintaining ongoing inspection readiness and compliance with the clinical trial protocol, Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations from study start-up through to site closure.

You should be flexible and be able to work independently. We are seeking to hire a strong communicator, a quick learner, a problem solver, and a real teammate.

You will be responsible for oversight of clinical trial protocols at a site level and will collaborate closely with he Clinical Trial Assistant (CTA, Trial Manager (TM) and Global Trial leader (GTL).


You will work in a hardworking, enthusiastic, and committed study team eager to deliver and help improve the lives of millions of patients.

You will also be part of a wider local Spanish team that provides mutual support and opportunities to work together to identify new and improved ways of working.


Principal Responsibilities:

  • Participates in site assessments, conducts pretrial visits, and collaborates on investigator selection with the trial team.
  • Acts as the primary contact for assigned sites for Early Development & Clinical Pharmacology (ED&CP) trials, closely working with the Trial Manager (TM) and central team for study progress and issue resolution.
  • Attends investigator meetings as needed.
  • Executes site initiation, monitoring, management, and closeout per internal SOPs. Implements Analytical Risk-Based Monitoring (ARBM) model. Monitors progress using study systems.
  • Ensures site staff have current Good Clinical Practice (GCP), protocol, compound, and systems training. Manages training records.
  • Contributes to sitelevel recruitment strategy and contingency planning.
  • Ensures adequate trial supplies. Handles clinical drug supplies with Pharmacy Investigational Product Specialist (PIPS) and Site Investigational Product Specialist (SIPS).
  • Ensures accurate data entry and timely query resolution.
  • Ensures valid and complete data, maintaining the blind as applicable.
  • Reports Adverse Events (AE)/Serious Adverse Events (SAE)/Product Quality Complaints (PQC) within required timelines. Maintains accurate data and documents.
  • Documents trial activities, deviations, and issues. Takes corrective actions.
  • Reviews site File, ensures archiving compliance.
  • Collaborates with TM to communicate site/study progress and issues.
  • Attends team meetings and trainings.
  • Acts as a local protocol expert, supporting multiple therapeutic areas.
  • Collaborates with TM for Corrective Action Preventive Action (CAPA) and site audits.
  • Prepares sites for closeout, conducts final visits.
  • Manages sitespecific consent forms.
  • Participates in Health Authority (HA) and Independent Ethics Committee/Institutional Review Board (IEC/IRB) processes.
  • Tracks sitelevel costs and ensures payments or collaborates with Contracts & Grants (C&G).
  • Builds relationships with stakeholders and acts as site management expert.
  • Coordinates site lessons learned and contributes to process improvement and training as needed.
  • Coaches and mentors SMs, performs site visits.

Qualifications:

Education & Experience:

  • A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field(or equivalent experience) is required.
  • A minimum of 3 years of clinical trial monitoring experience is preferred; however, other relevant experiences and skills may be considered.
  • Experience in monitoring ED&CP studies is preferred.
  • Specific therapeutic area experience/knowledge may be required.
  • Solid understanding of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
  • Strong IT skills in appropriate software and company systems.
  • Willingness to travel with occasional/regular overnight stay away from home depending on the region.
  • Proficient in speaking and writing the Spanish and English.
  • Flexible mindset and ability to work at a fast pace within small exploratory international study teams in a fastchanging environment.
  • Ability to work on multiple trials in parallel in different disease areas.

Benefits:

We offer a competitive salary and extensive benefits package.

The health and well-being of our employees is a priority, we have a flexible working environment as we value work-life balance.

We offer career development opportunities for those who want

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