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Site Manager - GCO
Requisition ID: 1805620944W
Johnson & Johnson Services, Inc. is recruiting for a SENIOR SITE MANAGER to be located in ISTANBUL.
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
With $70.1 billion in 2015 sales, Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. There are more than 265 Johnson & Johnson operating companies employing approximately 126,500 people and with products touching the lives of over a billion people every day, throughout the world.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. And our culture is interconnected by the shared values of Our Credo. It’s a culture that celebrates diversity and diverse perspectives. It helps employees achieve an effective mix between work and home life and supports their efforts to have a positive impact on their communities.
Summary of the job:
· A Site Manager is the person in Trial Co-ordination and Site Management that serves as a primary contact point between the sponsor and the investigational site. A 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 selection, pretrial assessment, subject recruitment and retention planning, site initiation, monitoring and close-out. Partner with the CTA/IDA, LTM and GTM to ensure overall site management while performing trial related activities for assigned protocols. May contribute to process improvement and training
Duties & Responsibilities
1. Participates in site feasibility and/or pre-trial site assessment visits, providing recommendation from local area about site/investigator selection in collaboration with the trial team
2. Acts as primary local company contact for assigned sites for specific trials.
3. Attends/participates in investigator meetings as needed.
4. 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.
5. Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases
6. Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
7. Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.
8. Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented.
9. Arranges the appropriate destruction of clinical supplies
10.Ensures site staff complete the data entry and resolve queries within expected timelines.
11.Ensures accuracy, validity and completeness of data collected at trial sites
12.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.
13.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.
14.Fully documents trial related activities in particular monitoring. Writes visit reports and uploads into eTMF within 5 working days for review and approval. Complete follow-up letter to communicate relevant information and required corrective action to the investigator and his/her team with 15 working days. Promptly communicates relevant status information and issues to appropriate stakeholders.
15.Follows the corresponding Monitoring Guidelines for each assigned trial.
16.Reviews TCF for completeness and ensures archiving retention requirements, including storage in a secure area at all times.
17.Collaborates with LTM for documenting and communicating site/study progress and issues to trial central team.
18.Attends regularly scheduled team meetings and trainings.
19.Complies with relevant training requirements. Act as local expert in assigned protocols. Develop therapeutic knowledge sufficient to support roles and responsibilities.
20.Works closely with LTM 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.
21.May participate in the HA and IEC/IRB submission and notification processes as required/appropriate.
22.Prepares trial sites for close out, conduct final close out visit.
23.Negotiates investigator budgets at site level, if applicable.
24.Tracks costs at site level and ensure payments are made, if applicable.
25.Establishes and maintains good working relationships with internal and external stakeholders, in particular investigators, trial coordinators and other site staff.
26.May contribute to process improvement and training
A minimum of a BA/BS degree is required. A degree in a health or science related field is preferred, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
A minimum of 1 year 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.
Good working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
Good IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home.
Johnson & Johnson Sihhi Malzeme Ltd. (7347)
Klinik Arastirma Yönetimi