Senior Site Manager - Cross Therapeutic Area - Florida

Johnson & Johnson Innovative Medicine•Somerville, FL

1d•Remote

About The Position

Johnson & Johnson Innovative Medicine R&D is recruiting for a Senior Site Manager - Cross Therapeutic Area - Florida. This is a remote role available within the state of Florida. The Senior Site Manager (Senior SM) will serve as the primary contact point between the Sponsor and the Investigational Site. The Senior SM 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. This individual may assist with site selection, site qualification assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring and close-out activities. 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, training and the mentoring of other SMs. Operate independently with little or limited supervision.

Requirements

A minimum of a Bachelor’s degree in Pharmacy, Nursing, Life Sciences, or related scientific Discipline is required.
A minimum of 2 years of clinical trial monitoring experience is required.
Knowledge of the drug development process, including Good Clinical Practices (GCPs) and FDA Code of Federal Regulations, is required.
Strong working knowledge of GCPs, company SOPs, local laws and regulations, assigned protocols and associated protocol specific procedures, including monitoring guidelines, is required.
Strong computer skills in appropriate software applications and related clinical systems required.
Must have strong written and oral communication skills.
Willingness to travel up to 75% with overnight stay away from home is required.
A valid Driver's License issued in one of the 50 United States and a good driving record is required.

Nice To Haves

Experience in the Immunology, Neuroscience and Rare Disease therapeutic areas preferred.
Experience with Phase II and Phase III Clinical Trials is preferred.

Responsibilities

Act as primary local company contact for assigned sites for specific trials.
Actively participate in site feasibility and/or Site Qualification Visits (SQVs).
Attend/participate in investigator meetings as needed. May be expected to help prepare meeting materials and may be required to present at the investigator meeting.
Execute 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.
Implementation of analytical risk-based monitoring model at the site level and work with the site to ensure timely resolution of issues found during monitoring visits.
Implement and execute all tasks independently with little or limited supervision.
Ensure site staff are trained, and the corresponding training records are complete and accurate at any point during all trial phases.
Collaborate closely 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.
May be required to help provide solutions to challenges faced in other sites in the country.
Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas.
Ensure site study supplies (such as Non-Investigational Product (IP), lab kits, etc.) are adequate for trial conduct.
Ensure that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented.
Arrange for the appropriate destruction of clinical supplies.
Ensure site staff complete data entry and resolve queries within expected timelines.
Ensure accuracy, validity and completeness of data collected at trial sites.
Proactively ensure 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, 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 relevant systems utilized for trial management.
Fully document trial related activities, in particular monitoring. Write visit reports and follow-up letters in accordance with the SOPs.
Promptly communicate relevant status information and issues to appropriate stakeholders.
Reviews study files for completeness and ensure archiving retention requirements are met, including storage in a secure area at all times.
Collaborate with LTM 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.
Possess proficient therapeutic knowledge sufficient to support role and responsibilities.
Work 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)).
May be required to oversee audit and inspection preparation by Associate SM.
Prepare trial sites for close out and conduct final close out visit.
Track costs at site level and ensure payments are made, if applicable.
Establish and maintain good working relationships with internal and external stakeholders, in particular investigators, trial coordinators and other site staff.
May participate in the Health Authority (HA) and Independent Ethics Committee (IEC)/Institutional Review Board (IRB) submission and notification processes as required/appropriate.
Act as a point of contact in site management practices.
Provide credible and useful insights and input.
May be assigned as a coach and mentor to a less experienced site manager.
May be required to contribute to process improvement and training.
Occasionally lead and/or participate in special initiatives as assigned.
May assume additional responsibilities or special initiatives such as “Champion” or Subject Matter Expert”.

Benefits

Annual performance bonus
Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation - 120 hours per calendar year
Sick time - 40 hours per calendar year
Holiday pay, including Floating Holidays - 13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member
Caregiver Leave - 10 days
Volunteer Leave - 4 days
Military Spouse Time-Off - 80 hours