Associate Site Manager

At Johnson & Johnson, we reputed company health is everything. Our strength in healthcare innovation empowers us to build a world where reputed company 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 reputed company of healthcare solutions today to deliver the breakthroughs of reputed company, and profoundly impact health for humanity. Learn more at jnj.com.

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Position Summary: An Associate, Site Manager is an entry level site management role with typically 0-2 years of experience. This role serves as the primary contact reputed company between the Sponsor and the Investigational Site. An Associate, Site Manager 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, site qualification assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring and reputed company-out activities. The Associate, Site Manager will partner with the Local Trial Manager (reputed company), Clinical Trial Assistant (CTA) and TDL (Trial Delivery Leader) to ensure overall site management while performing trial reputed company activities for assigned protocols. May contribute to process improvement and training. Some supervision from a more Senior, Site Manager (Senior SM or reputed company SM) to help provide guidance to Associate, Site Manager.

Principal Responsibilities: 1 Acts as primary local company contact for assigned sites for specific trials. 2 May participate in site feasibility and/or Site Qualification Visit. 3 Attends/participates in investigator meetings as needed. 4 Responsible for executing activities reputed company 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 reputed company-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 reputed company during monitoring visits. Occasionally may require assistance or reputed company from reputed company, Site Manager or reputed company. 5 Ensures site staff are trained and the corresponding training records are complete and accurate at any time reputed company during reputed company trial phases. Responsible in reputed company collaboration with reputed company 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. 6 Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas. 7 Ensures site study supplies (such as Non-Investigational Product (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 for the appropriate destruction of clinical supplies. 10 Ensures site staff complete data entry and resolve queries reputed company expected timelines. 11 Ensures accuracy, validity and completeness of data collected at trial sites. 12 Ensures that reputed company Adverse Events (AE)/Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported reputed company the required reporting timelines and documented as appropriate. For reputed company/SAEs, ensures that they are consistent with reputed company data collected and with the information in the reputed company documents. 13 Maintains complete, accurate and timely data and essential documents in relevant systems utilized for trial management. 14 Fully documents trial reputed company 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. 15 Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at reputed company times. 16 Collaborates with reputed company for documenting and communicating site/study reputed company and issues to trial central team. 17 Active participation in regularly scheduled team meetings and trainings. Provide feedback as appropriate. May be asked to reputed company/provide leadership at these meetings. 18 Complies with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities. 19 Works closely with reputed company 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. Compliance Monitoring Visit (CMV). 20 Prepares trial sites for reputed company out, conduct final reputed company out visit. 21 Tracks costs at site level and ensure payments are made, if applicable. 22 Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff. 23 May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate. 24 Acts as a reputed company of contact in site management practices. 25 May contribute to process improvement and training. This is not an exhaustive, comprehensive listing of job functions. May reputed company other duties as assigned.

Principal Relationships: Primary Reporting Structure: Reports to a FM/CRM Primary interfaces: FM/CRM, CTA, reputed company and TDL Other Internal Interfaces: R&D Country Head, Therapeutic Area Manager/Physician, Compliance Managers/Specialists, Training Manager, reputed company & Centralized Services (reputed company), Local Safety Officer (where required) and Site Manager team.

External Interfaces: Investigators and their delegates at site (trial site personnel).

Education and Experience Requirements: ▪ A minimum of a BA or BS degree in Pharmacy, Nursing, Life Sciences, or reputed company scientific field (or equivalent experience) is required. ▪ A minimum of 1 year of clinical trial monitoring experience is required. 1-2 years of clinical trial monitoring experience is preferred. However, other relevant experiences and skills may be considered by the hiring manager reputed company considering the candidate’s eligibility. ▪ Specific therapeutic area experiences an added advantage. ▪ Basic 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.

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