Ed&cp Site Manager I - Madrid, España - Johnson & Johnson

Johnson & Johnson

Empresa verificada

Madrid, España

hace 1 semana

Publicado por:

Isabel García

beBee Recruiter

Descripción

For More Than 130 Years, Diversity, Equity & Inclusion (DEI) Have Been Part Of Our Cultural Fabric At Johnson & Johnson And Woven Into How We Do Business Every Day.

Our Commitment To Respect The Dignity And Diversity Of All Is Embedded In Our Credo.

We Know That The Success Of Our Business Depends On Having The Best Talent In A Workforce That Reflects The Diverse Markets We Serve Around The World And An Inclusive Culture That Values Different Perspectives And Life Experiences

That Is Why We In Spain Are Working To Create An Inclusive Environment Where Diverse Backgrounds, Perspectives And Experiences Are Valued And Each And Every One Of Our People Feels That They Belong And Can Reach Their Potential.

No Matter Who They Are.

Diversity, Equity & Inclusion At Johnson & Johnson Means "You Belong"

A Site Manager I may contribute to process improvement and training.

Principal Responsibilities:

- (List Major Responsibilities and duties of the position. Describe scope of responsibilities.) _

Participates in site assessments, conducts pretrial site assessment visits and/or participates to study feasibility assessments, providing recommendation from local area about site/investigator selection in collaboration with the trial team
Acts as primary contact for assigned sites for specific ED&CP trials and works closely with TM and trial central team regarding study progress and issue resolution.
Attends/participates in investigator meetings as needed.
Responsible for executing activities within site initiation and startup, site monitoring, site management and site/study closeout per internal SOPs, other procedural documents and policies.
Ensures site staff have current GCP and necessary protocol, compound and systems training to conduct the clinical trial. Complete retraining when needed. Ensure training records are filed at sites and sponsor level.
Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.
In collaboration with Site Investigational Product Specialist (SIPS) and Pharmacy Investigational Product Specialist (PIPS), ensures that clinical drug supplies are appropriately handled, administered and stored. Ensure strict adherence to investigational product preparation and administration guidelines. Ensures clinical drug supplies are appropriately inventoried, accounted and returned as applicable including maintenance of accurate and complete documentation.
Ensures site staff complete the data entry and resolve queries within expected timelines. Set up plan to improve data entry in collaboration with TM when needed.
Ensures accuracy, validity and completeness of data collected at trial sites. Ensure appropriate measures are in place for maintenance of the blind when applicable
Ensures that all Adverse Events (AEs)/Serious Adverse events (SAEs)/Product Quality Complaints (PQC) are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensure that they are consistent with all data collected and with the information in the source documents.
Maintains complete, accurate and timely data and essential documents in systems utilized for trial management.
Fully documents trial related activities with respect to study monitoring. Writes visit reports and address followup letters to investigators within procedural timelines. Responsible for documentation and escalation of major deviations and issues to appropriate stakeholders. Ensures timely corrective actions are completed and documented.
Reviews investigator site file for completeness and ensures archiving retention requirements, including storage in a secure area at all times.
Collaborates with TM for documenting and communicating site/study progress and issues to trial central team.
Attends regularly scheduled team meetings and trainings.
Complies with relevant training requirements. Acts as local expert in assigned protocols. Develops sufficient therapeutic area and early development knowledge to support roles and responsibilities. Works across therapeutic areas dependent upon ED&CP business needs.
Works closely with TM to ensure Corrective Action Preventive Action (CAPA) is completed for QA site audits or Inspection and for quality issues identified at the site during routine monitoring and other visit types, e.g., On Site Quality Monitoring visit (OSQMV).
Prepares trial sites for close out, conduct final close out visit.
May review and manage site specific informed consent forms in accordance with GCO SOPs, procedural documents and applicable regulations.
May participate in the HA and IEC/IRB submission and notification processes as required/appropriate.
Tracks costs at site level and ensure payments are made, if applicable or collaborates with C&G in charge of si