Senior Site Manager

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Position Summary:
A Senior Site Manager is a mid-level site management role with typically 3-5 years ofexperience. This role serves as the primary contact point between the Sponsor and theInvestigational Site. A Senior Site Manager is assigned to trial sites to ensure inspectionreadiness through compliance with the clinical trial protocol company Standard OperatingProcedures (SOP) Good Clinical Practice (GCP) and applicable regulations and guidelinesfrom study start-up through to site closure. Responsibilities may include assisting with siteselection site qualification assessment subject recruitment and retention planning siteinitiation on-site and remote monitoring and close-out activities. The Senior Site Manager willpartner with the Local Trial Manager (LTM) Clinical Trial Assistant (CTA) and TDL (TrialDelivery Leader) to ensure overall site management while performing trial related activities forassigned protocols. A Senior Site Manager may contribute to process improvement trainingand mentoring of other Site Managers. A Senior Site Manager is generally expected to be ableto operate independently with little or limited supervision.

Principal Responsibilities:
1. Acts as primary local company contact for assigned sites for specific trials.
2. Actively May participate in site feasibility and/or Site Qualification Visit.
3. Attends/participates in investigator meetings as needed may be expected to help preparemeeting materials and may be required to present at the IM.
4. Responsible for executing activities within site initiation and start-up preparation and conductof site monitoring (including remote monitoring) site management (by study specific systemsand other reports/dashboards) and site/study close-out according to SOPs Work Instructions(WIs) and policies. Responsible for the implementation of analytical risk-based monitoringmodel at the site level and to work with site to ensure timely resolution of issues found duringmonitoring visits. Able to implement and execute all tasks independently with little or limitedsupervision.
5. Ensures site staff are trained and the corresponding training records are complete andaccurate at any time point during all trial phases. Responsible in close collaboration withLTM and central study team for the activities during site activation phase in order to speed upthe process and activate the site in shortest possible timeframe. May be required to helpprovide solutions to challenges faced in other sites in the country.
6. Contributes to site level recruitment strategy and contingency planning and implementation inpartnership with other functional areas.
7. Ensures site study supplies (such as Non-Investigational Product (IP) lab kits etc.) areadequate for trial conduct.
8. Ensures that clinical drug supplies are appropriately used handled and stored and returnsare 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. Proactively ensures that all Adverse Events (AE)/Serious Adverse Events (SAEs)/ProductQuality Complaints (PQCs) are reported within the required reporting timelines anddocumented as appropriate. For AEs/SAEs ensures that they are consistent with all datacollected and with the information in the source documents.
13. Maintains complete accurate and timely data and essential documents in relevant systemsutilized for trial management.
14. Fully documents trial related activities in particular monitoring. Writes visit reports andfollow-up letter in accordance with the SOPs. Promptly communicates relevant statusinformation and issues to appropriate stakeholders.
15. Reviews study files for completeness and ensures archiving retention requirements are metincluding storage in a secure area at all times.
16. Collaborates with LTM for documenting and communicating site/study progress and issues totrial central team.
17. Attends regularly scheduled team meetings and trainings.
18. Complies with relevant training requirements. Act as local expert in assigned proficient therapeutic knowledge sufficient to support role and responsibilities.
19. Works closely with LTM to ensure Corrective Action Preventative Action (CAPA) iscompleted for Quality Assurance (QA) site audits and for quality issues identified at the siteduring routine monitoring and other visit types e.g. Compliance Monitoring Visit (CMV). Maybe required to oversee audit and inspection preparation by Associate SM.
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 stakeholdersin particular investigators trial coordinators and other site staff.
23. May participate in the Health Authority (HA) and IEC/IRB submission and notificationprocesses as required/appropriate.
24. Acts as a point of contact in site management practices. Able to provide credible and usefulinsights and input.
25. On need basis may be assigned as a coach and mentor to a less experienced site manager.
26. May be required to contribute to process improvement and training.
27. Occasionally leads and/or participates in special initiatives as assigned.
28. May be required to assume additional responsibilities or special initiatives such asChampion or Subject Matter Expert.

This is not an exhaustive comprehensive listing of job functions. May perform other duties asassigned.

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/PhysicianCompliance 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 scientificfield (or equivalent experience) is required.
A minimum of 2 years of clinical trial monitoring experience is required. 3-5 years of clinicaltrial monitoring experience is preferred however other relevant experiences and skills maybe considered by the hiring manager when considering the candidates eligibility.
Specific therapeutic area experience may be required depending on the position and is anadded advantage.
Strong working knowledge of GCP company SOPs local laws and regulations assignedprotocols 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 oralcommunication.
Ability to work on multiple trials in parallel.
Demonstrated capability to consistently deliver clinical trials.
Demonstrated capability to effectively communicate and engage with sites and sitespersonnel.
Demonstrated problem solving capability

Required Skills:

Preferred Skills: