Senior Local Trial Manager (Investigator Initiated Studies) (1 of 3 positions)-4709140917
Description
Janssen Research & Development, LLC., a member of the J&J Family of Companies, is recruiting for a Senior Local Trial Manager (Investigator Initiated Studies) located in Raritan or Titusville, NJ OR regionally based throughout the United States.
Performs the role of a Sr. Local Trial Manager (LTM) including operational oversight of assigned Investigator Initiated Studies (IIS) from start-up through closeout activities as described in GCO procedural documents.
The Sr. LTM is responsible for local management of an IIS supported by Medical Affairs or R&D and is the primary point of contact with Sponsor-Investigator (S-I)/staff, scientific field staff (as applicable) and Janssen Operating Company contacts with respect to assigned IIS studies.
The Sr. LTM is responsible for assuring that study progress, safety reporting, drug and financial management adheres to the contract and Janssen processes and trial documents/records that are compliant with assigned study, codes of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs) and regulatory requirements.
The Sr. LTM actively contributes to process improvement; training and mentoring of Clinical Trial Assistants and other LTMs.
PRINCIPAL RESPONSIBILITIES:
Performs IIS study activities from start-up through close-out in compliance with GCO Standard Operating Procedures (SOP), Work Instructions (WI) and applicable regulations including project management activities to meet study completion dates, financial management including budget forecasting and payments, issue identification and resolution and risk management.
Acts as the central contract for designated project communications, correspondence and associated documentation for assigned IISs. Acts as the central contract for designated project communications, correspondence and associated documentation for assigned IISs.
Contributes input to protocol/ICF and contract/budget review to assure adherence to Janssen requirements for support of IISs.
Collaborates with the CPL, GTM, and Medical Affairs/R&D and other subject matter experts on operational activities for assigned IIS studies.
Ensures that all required safety reporting (SAEs/non-serious AEs, PQCs) are reported within reporting timelines.
Maintains and updates trial management systems (e.g. CTMS, TMF and SharePoints).
Uses study tools and management reports available to analyze trial progress
Monitors study progress and initiates corrective and preventive actions when the trial deviates from plans and communicates study progress and issues to study team members.
Reviews IIS contract/budget for operational issues and adherence to Health Care Compliance requirements for budgets/payment schedules.
Forecasts and manages IIS budget to ensure accurate finance reporting.. Adheres to finance reporting deliverables and timelines.
Attends and participates in Medical Affairs/R&D IIS review meetings.
Reviews and approves site invoices as required
Works with GTM to ensure a CAPA is implemented for audits and inspection or any quality related visits.
Complies with relevant training requirements.
Acts as local expert for assigned protocols. Develops strong therapeutic knowledge to support roles and responsibilities. May represent Global Clinical Operations on cross functional teams.
Acts as primary contact for a trial. Establishes and maintains excellent working relationships with external stakeholders, in particular investigators, study trial coordinators and other site staff; and internal stakeholders, including Medical Affairs and R&D Therapeutic Areas.
Actively contributes to process improvement; training and mentoring of Clinical Trial Administrators, and other LTMs.
Qualifications
A minimum of a BA/BS degree is required. A degree in a health or science related field is preferred.
A minimum of four years of pharmaceutical and/or clinical trial experience is required. Experience in managing Investigator Initiated Studies and study types (e.g. interventional, non-interventional, and/or registries) is required. Specific therapeutic area experience may be required depending on the position. Should have solid understanding of the drug development process including ICH/GCP and local regulatory requirements. Solid communication and computer skills required. Proficient in speaking and writing the country language and English language. Good written and oral communication skills is required.
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Primary Location:North America-United States-New Jersey-Raritan
Other Locations:North America-United States-New Jersey-Titusville, North America-United States
Organization: Janssen Research & Development, LLC. (6084)
Job Function: Clinical Trial Administration
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