- Participates in site/lab assessments, pre-trial site assessment visits and/or 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 TA staff regarding study progress and issue resolution.
- Attends/participates in investigator meetings as needed.
- Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies.
- Ensures site staff have current GCP and necessary protocol and compound training to conduct the clinical trial. Complete retraining when needed. Ensure training records are filed internally.
- 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.
- Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented.
- Arranges the appropriate destruction of clinical supplies
- Ensures site staff complete the data entry and resolve queries within expected timelines.
- Ensures accuracy, validity and completeness of data collected at trial sites
- Ensures that all AEs/SAEs/PQCs 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 (e.g. CTMS, eTMF/IF, Trial Master Source and Sharepoints).
- Fully documents trial related activities with respect to study monitoring, e.g writing of visit reports and completion of follow-up letters to investigators. Responsible for documentation and escalation of major deviations and issues to appropriate stakeholders. Ensures timely corrective actions are completed and documented.
- Follows the corresponding Monitoring Guidelines for each assigned trial.
- Reviews TCF 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. Act as local expert in assigned protocols. Develop therapeutic knowledge sufficient to support roles and responsibilities.
- Works closely with TM to ensure CAPA is completed for QA site audits and for quality issues identified at the site during routine monitoring and other visit types, e.g…,OSQMV.
- May participate in the HA and IEC/IRB submission and notification processes as required/appropriate.
- Prepares trial sites for close out, conduct final close out visit.
- Negotiates investigator budgets at site level, if applicable.
- Tracks costs at site level and ensure payments are made, if applicable.
- Establishes and maintains good working relationships with internal and external stakeholders, in particular investigators, trial coordinators, other site staff and key contacts in Early Development and/or Clinical Pharmacology.
- Coordinates site level lessons learned activities.
- Acts as a subject matter expert in site management practices
- Assigned as a coach and mentor to less experienced site managers, as needed
- Contributes to process improvement and training, as needed
- Leads and/or participates in special initiatives as assigned.
- 4-year University degree in Life Sciences, Nursing, or related scientific field is required.
- A minimum of 2 years of clinical trial monitoring experience is preferred, particular in monitoring ED&CP studies is preferred; however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
- Specific therapeutic area experience may be required.
- Strong knowledge 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 country language and English. Good written and oral communication skills.
- Flexible mindset and ability to work at a fast pace within small exploratory study teams with accelerated cycle times
- Ability to work on multiple trials in parallel in different disease areas
Janssen Pharmaceutica N.V. (7555)
Clinical Trial Administration