Johnson & Johnson Careers
Requisition ID: 1905735404W
At Janssen, were are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases, and vaccines, cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson& Johnson (J&J). Please visit http://www.janssen.co.uk/ for more information.
As the Site Manager you will act as the primary contact point between the Sponsor and the Investigational Site. Poted at trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. Your responsibilities may include assisting with site selection, pre-trial assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring and close-out activities. Partnering with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA) and Clinical Trial Manager (CTM) to ensure overall site management while performing trial related activities for assigned protocols.
This role will be working 60-70% of the time off site and will require a clean driving licence and the ability to travel.
- Acting as primary local company contact for assigned sites for specific trials.
- Participating in site feasibility and/or pre-trial site assessment visits
- Attending /participating in investigator meetings as needed.
- Responsibility for executing activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. You will have responsibility for the implementation of analytical risk based monitoring model at the site level and to work with site to ensure timely resolution of issues found during monitoring visits.
- Ensuring site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with LTM and central study team for the activities during site activation phase in order to speed up the process and activate the site in shortest possible timeframe.
- Contributing to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas.
- Ensuring site study supplies (such as Non-Investigational Product (IP), lab kits, etc.) are adequate for trial conduct.
- Ensuring that clinical drug supplies are used appropriately, handled and stored and returns are accurately inventoried and documented.
- Arranging for the appropriate destruction of clinical supplies.
- Overseeing site staff to ensure complete data entry and resolve queries within expected timelines. As well as ensuring accuracy, validity and completeness of data collected at sites
- Ensuring that all Adverse Events (AE) /Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents.
- Maintaining complete, accurate and timely data and essential documents in relevant systems utilized for trial management.
- Fully documents trial activities. Writing visit reports and follow-up letter in accordance with the SOPs. Promptly communicating relevant status information and issues to appropriate partners.
- Reviewing study files for completeness and ensures archiving retention requirements are met, including storage in a secure area.
- Collaborating with LTM for documenting and communicating site/study progress / issues to trial central team.
- Working closely with LTM to ensure Corrective Action Preventative Action (CAPA) to completion for Quality Assurance (QA) site audits and for quality issues identified on site during routine monitoring and other visit types, e.g. On Site Quality Monitoring Visit (OSQMV).
- Preparing trial sites for close out, conduct final close out visit.
- Establishing and maintaining good working relationships with internal and external partners in particular investigators, trial coordinators and other site staff.
- Participating in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate.
Do you meet the following Education and Experience Requirements?
- A BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience)
- A minimum of 1 year of clinical trial monitoring experience
- Strong working knowledge of GCP, company SOPs, 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 overnight stay away from home.
- Proficient in speaking and writing the country language and English. Good written and oral communication.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United Kingdom-England-High Wycombe-
Janssen Cilag Ltd. (7360)
Clinical Trial Administration