Lead Site Manager - Early Development

Johnson & Johnson Innovative Medicine R&D is recruiting for a Lead Site Manager - Early Development. This position can be located remotely within the United States, preferably in the Southeast region.

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/

• Participate in site assessments, conduct pre-trial site assessment visits and/or participate to study feasibility assessments, providing recommendations from local area about site/investigator selection in collaboration with the trial team.
• Act as primary contact for assigned sites for specific ED&CP trials and work closely with TM and trial central team regarding study progress and issue resolution.
• Attend/participate in investigator meetings as needed.
• Execute activities within site initiation and start-up, site monitoring, site management and site/study close-out per internal SOPs, other procedural documents and policies. Implementation of Analytical Risk Based Monitoring (ABRM) model at the site level when applicable. Monitor study progress at site using study specific systems and available reports/dashboards.
• Ensure site staff have current GCP and necessary protocol, compound and systems training to conduct the clinical trial. Complete retraining when needed. Ensure training records are filed at site and sponsor level.
• Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
• Ensure site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.
• In collaboration with Pharmacy Investigational Product Specialist (PIPS) and Site Investigational Product Specialist (SIPS), ensure that clinical drug supplies are appropriately handled, administered, and stored. Ensure strict adherence to investigational product preparation and administration guidelines. Ensure clinical drug supplies are appropriately inventoried, accounted and returned as applicable, including maintenance of accurate and complete documentation.
• Ensure site staff complete the data entry and resolve queries within expected timelines. Set up plan to improve data entry in collaboration with TM when needed.
• Ensure accuracy, validity and completeness of data collected at trial sites. Ensure appropriate measures are in place for maintenance of the blind when applicable.
• Ensure that all Adverse Events (AE)/Serious Adverse Events (SAE)/Product Quality Complaints (PQC) 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.
• Maintain complete, accurate and timely data and essential documents in systems utilized for trial management.
• Fully document trial related activities with respect to study monitoring. Write visit reports and address follow-up letters to investigators within procedural timelines. Document and escalate major deviations and issues to appropriate stakeholders. Ensure timely corrective actions are completed and documented.
• Review investigator site file for completeness and ensure archiving retention requirements, including storage in a secure area at all times.
• Collaborate with TM for documenting and communicating site/study progress and issues to trial central team.
• Attend regularly scheduled team meetings and trainings.
• Comply with relevant training requirements. Act as local expert in assigned protocols. Develop sufficient therapeutic area and early development knowledge to support roles and responsibilities. Work across therapeutic areas dependent upon ED&CP business needs.
• Work closely with TM to ensure Corrective Action Preventive Action (CAPA) is completed for quality assurance site audits or inspection and for quality issues identified at the site during routine monitoring and other visit types (e.g., On Site Quality Monitoring Visit (OSQMV)).
• Prepare trial sites for close out, conduct final close out visit.
• May review and manage site specific informed consent forms in accordance with Global Clinical Operations (GCO) SOPs, procedural documents and applicable regulations.
• May participate in the Health Authority (HA) and Independent Ethics Committee (IEC)/Institutional Review Board (IRB) submission and notification processes as required/appropriate.
• Track costs at site level and ensure payments are made, if applicable or collaborate with Contracts and Grants (C&G) in charge of site payments.
• Establish and maintain good working relationships with internal and external stakeholders, in particular investigators, trial coordinators, other site staff and key contacts in ED&CP.
• Coordinate site level lessons learned activities.
• Act as a subject matter expert in site management practices.

• A minimum of a Bachelor's degree is required, preferably in a Health, Science or Nursing (RN) discipline.
• A minimum of 6 years of clinical trial monitoring experience is required.
• Experience monitoring early development and clinical pharmacology studies (Phase 0, Phase I or Phase Ib) is preferred.
• Experience in the Oncology Therapeutic Areas is required.
• Experience with CAR-T (Cell and Gene Therapy) is preferred.
• Strong knowledge of the drug development process, including International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP), company SOPs, local laws and regulations, assigned protocols and associated protocol specific procedures and monitoring guidelines, is required.
• Experience mentoring/coaching and providing training to others is preferred.
• Strong computer skills in appropriate software applications and related clinical systems required.
• Must have strong written and oral communication skills.
• Must have strong leadership skills with the ability to lead initiatives.
• Must have a flexible mindset with the ability to work at a fast pace within small exploratory international study teams in a fast-changing environment.
• The ability to work on multiple trials in parallel in different disease areas required.
• Willingness to travel up to 50%, approximately 2-3 days per week, with overnight stays (1-2 nights on average), is required.
• A valid Driver's License issued in one of the 50 United States and a good driving record is required.

• Vacation - up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
• Holiday pay, including Floating Holidays - up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year