At Janssen, we 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.
A Senior Site Manager (Site Manager II) serves as the primary contact point between Janssen (The pharmaceutical division of Johnson & Johnson) and the Investigator Site. In other organisations, the Site Manager may be known as Clinical Research Associate or Monitor. The head office location is in High Wycombe, Buckinghamshire, and this position is home-based.
You will be assigned to 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. 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. We may require your contribution to process improvement, training and mentoring of other Site Managers.
- Acting as primary local company contact for assigned sites for specific trials and participating in site feasibility and/or pre-trial site assessment visits as well as investigator meetings.
- 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. Responsible 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.
- 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 accuracy, validity and completeness of data collected at trial 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, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates 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 at all times.
- Collaborating with LTM for documenting and communicating site/study progress and issues to trial central team.
- Following training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities.
- Working closely with LTM to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the 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.
- Tracking costs at site level and ensure payments are made, if applicable.
- Establishing and maintaining good working relationships with internal and external partners in particular investigators, trial coordinators and other site staff.
Do you have the Education and experience we are looking for?
- BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.
- A proven background in clinical trial monitoring experience is preferred, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
- Experience monitoring Oncology clinical trials.
- Specific therapeutic area experience may be required depending on the position.
- Strong working knowledge of GCP, company SOPs, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
- Willingness to travel with occasional overnight stay away from home.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United Kingdom-England-High Wycombe-
Janssen Cilag Ltd. (7360)
Clinical Trial Administration