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ED&CP Site Manager Level 2 Beerse Belgium,
Johnson & Johnson (company)
Posted on : 10 July 2017
A Senior Site Manager is the person in Early Development & Clinical Pharmacology (ED&CP) that serves as a primary contact point between the sponsor and the investigational site (both commercial and hospital) for the conduct of more complex early development and/or clinical pharmacology studies. A Senior Site Manager is assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), applicable regulations and guidelines from start-up through data-base lock.
Responsibilities include site/lab assessments, pre-trial assessments, site selection, site initiation, subject recruitment and retention, monitoring and close-out. Partners with the Clinical Trial Assistant (CTA)/Investigator Document Assistant (IDA), Trial Manager (TM) and Global Trial Manager (GTM) to ensure overall site management while performing trial related activities for assigned protocols. Contribute to process improvement, training and mentoring of other Site Managers.
- 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.
Reports to a functional manager
Primary interfaces: Functional Manager/Supervisor, Clinical Trial Administrator, Trial Manager, Therapeutic Area Manager/Physician and Study Management Team for assigned clinical studies.
Other Internal Interfaces: E.g. Quality & Compliance Manager/Specialist, Training Manager, Local Drug Safety Officer (where required).
External Interfaces: Investigators and their delegates at site (trial site personnel).
EDUCATION AND EXPERIENCE REQUIREMENTS:
- 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
What s in it for you &?
Caring for the world, one person at a time &
As an employee we consider you as our most valuable asset. We take your career seriously.
As part of a global team in an innovative environment your development is key and our day-to-day responsibility.
Through e-university, on the job training, various projects and programs, we ensure your personal growth.
Our benefits make sure we care for you and your family now and in the future.
Janssen Pharmaceutica N.V. (7555)
Clinical Trial Administration
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