Summary
Established and productive individual contributor, who works under moderate supervision. Manages components of clinical trial processes from strategy to approvals. Examines processes for regulatory strategies throughout clinical trials and identifies opportunities to minimize timelines and improve success rates for product registration. Provides representation, strategy, and support for phases of clinical trials under limited supervision.
Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
Job Function:
R&D OperationsJob Sub Function:
Clinical Trial SupportJob Category:
ProfessionalAll Job Posting Locations:
Kibbutz Shefayim, Center District, IsraelJob Description:
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
We are searching for the best talent for Senior Site Manager to be in Shefayim.
A Site Manager II (SM II) serves as the primary contact point between the Sponsor and the Investigational
Site. A Site Manager II is 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. Site Manager will partner 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. A Site Manager II may
contribute to process improvement, training and mentoring of other Site Managers.
You will be responsible for:
Acts as primary local company contact for assigned sites for specific trials.
May participate in site feasibility and/or pre-trial site assessment visits
Attends/participates in investigator meetings as needed.
Responsible for executing activities within site initiation and start-up, preparation and conduct of sitemonitoring (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.
Ensures 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 teamfor the activities during site activation phase in order to speed up the process and activate the site inshortest possible timeframe.
Contributes to site level recruitment strategy and contingency planning and implementation inpartnership with other functional areas.
Ensures site study supplies (such as Non-Investigational Product (IP), lab kits, etc.) are adequate for trialconduct.
Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented.
Arranges for the appropriate destruction of clinical supplies. LD Version 1.0 dated 18 October 2017 (FINAL) For Internal Use Only 10001467: Specialist 3, Clinical Trial Admin/Oper (PG 25)Page 2 of 3
Ensures site staff complete data entry and resolve queries within expected timelines.
Ensures accuracy, validity and completeness of data collected at trial sites
Ensures 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.
Maintains complete, accurate and timely data and essential documents in relevant systems utilized for trial management.
Fully documents trial related 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 stakeholders.
Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times.
A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience)
is required.
A minimum of 2 years of 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.
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.
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.
