Senior Local Trial Manager - Neuroscience/Immunology
Location:
Spring House , Pennsylvania
Posted:
January 12, 2017
Reference:
5732170109/2-en-us

Janssen Research & Development, LLC, a member of Johnson & Johnson’s Family of Companies, is recruiting for a Senior Local Trial Manager - Neuroscience/Immunology located in Spring House, PA.  Other possible locations: Titusville, NJ or Raritan, NJ.  Remote locations within the United States will be considered.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. 
 
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com for more information.
 
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.

The Senior Local Trial Manager (Senior LTM) will have responsibilities that include trial operations/oversight at the country level by ensuring study related activities are in compliance with all Global Clinical Operations (GCO) Standard Operating Procedures (SOPs), policies and regulatory requirements from start-up through data-base lock.
 
Additional responsibilities will include:
  • Supervise site/investigator selection process and monitor site performance for assigned country.
  • Partner with the Clinical Trial Assistant (CTA)/Investigator Document Assistants (IDA), Site Manager (SM), Contracts and Grants group and Global Trial Manager (GTM) to ensure overall site management while performing trial related activities for assigned protocols.
  • Represent functional area in divisional/company-wide process initiatives.
  • Support country/site feasibility assessment in conjunction with Lead LTM, CTA/IDA and GTM.
  • Collaborate with the Regional Therapeutic Area Expert (RTAE)/Clinical Program Leader (CPL), GTM and Protocol Owner to select final site list and hold weekly RSM meetings and provides SM training when needed (i.e. for implementation of study amendments/changes in study processes).
  • Contribute to the Trial Plan, Safety Monitoring Plan, Filing and Archiving Plan and Investigational Product documents at a country level or initiates for a single country trial.
  • Create various trial related documents including Country Feasibility Report, Trial Master Spreadsheet and country specific ICF template.
  • Submit requests for vendor services and support vendor selection.
  • Collaborate and review study budget with Global Operations Services and updates budget forecast in CTMS.
  • Review eCRFs/Completion guidelines and participate in EDC User Acceptance Testing (UAT) in conjunction with Lead SM/SM EDC Specialist.  Collaborate with Clinical Data Manager (CDM) during analyses to ensure report accuracy and to resolve site specific data issues.
  • Partner with vendors to ensure study supplies are provided to sites and participate in Interactive Voice Response System (IVRS) UAT.
  • Contribute to recruitment strategy and contingency plan in partnership with other functional areas to achieve clinical research targets.
  • Coordinate/present at Investigator Meetings as needed and attend regularly scheduled team meetings and trainings.
  • Track, review and sign-off on SM Trip Reports.  Identify trends across the project and escalate to the GTM as needed.
  • Process, review and approve site and local vendor invoices as well as support regulatory requests and ensure appendix 1.4.1 is accurate and complete.
  • Work with SM to ensure Corrective Action Plan is completed for Quality Assurance (QA) site audits and ensure, in collaboration with SM, the timely and accurate data collection, documentation and communication of study progress and issues.
  • Maintain/update the electronic Trial Master File (eTMF), LAF, Trial Master Source and SharePoint and ensure all activities are executed according to internal SOPs/WIs/IFUs and policies.
  • Function as Trial Manager for single country trials as needed and mentor new hires with supervision.  Participate in special initiatives as needed.

Qualifications
  • A minimum of a Bachelor's degree or equivalent experience is required.  A degree in a Health or Science discipline is preferred.
  • A minimum of 4 years of pharmaceutical experience is required.
  • Prior experience with Neuroscience and/or Immunology Therapeutic Areas preferred.
  • Previous clinical operations experience is preferred.
  • Knowledge of the drug development process, including Good Clinical Practices (GCP) and FDA Code of Federal Regulations, required.
  • Strong computer skills required.
  • Must have strong written and oral communication skills.
  • Minimal travel may be required.

Primary Location
United States-New Jersey-Raritan
Other Locations
North America-United States-Pennsylvania-Spring House, 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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