Associate Site Manager

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 Operations Job Sub Function Clinical Trial Support Job Category Professional All Job Posting Locations Mumbai India Position Summary An Associate Site Manager is an entry level site management role with typically 0-2 years of experience or Study coordinators with 3-4 years of experience This role serves as the primary contact point 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 close-out activities The Associate Site Manager will partner with the Local Trial Manager LTM Clinical Trial Assistant CTA and TDL Trial Delivery Leader to ensure overall site management while performing trial related activities for assigned protocols May contribute to process improvement and training Some supervision from a more Senior Site Manager Senior SM or Lead 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 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 Occasionally may require assistance or oversight from Lead Site Manager or LTM 5 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 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 within expected timelines 11 Ensures accuracy validity and completeness of data collected at trial sites 12 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 13 Maintains complete accurate and timely data and essential documents in relevant systems utilized for trial management 14 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 15 Reviews study files for completeness and ensures archiving retention requirements are met including storage in a secure area at all times 16 Collaborates with LTM for documenting and communicating site study progress and issues to trial central team 17 Active participation in regularly scheduled team meetings and trainings Provide feedback as appropriate May be asked to lead 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 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 Compliance Monitoring Visit CMV 20 Prepares trial sites for close out conduct final close 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 point 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 perform other duties as assigned Principal Relationships Primary Reporting Structure Reports to a FM CRM Primary interfaces FM CRM CTA LTM and TDL Other Internal Interfaces R D Country Head Therapeutic Area Manager Physician Compliance Managers Specialists Training Manager Contracts Centralized Services CCS 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 related 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 when 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 This individual will be in-house based with no travel to sites The role would be centralize start up activities and in-house site management and oversight Individual should be well versed with Regulatory eSUGAM completion requirements and importation and exportation requirements for clinical trials Individual should have experience with conducting site qualification visits This individual will be in-house based with no travel to sites The role would be centralize start up activities and in-house site management and oversight Individual should be well versed with Regulatory eSUGAM completion requirements and importation and exportation requirements for clinical trials Individual should have experience with conducting site qualification visits