Senior Local Trial Manager - Oncology (1 of 2) - 2406173469WDescriptionJanssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Local Trial Manager - Oncology. This position can be located remotely within the United States.At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.The Senior Local Trial Manager (Sr. LTM) is responsible for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. The Senior Local Trial Manager (Sr. LTM) is the primary point of contact at a country level for assigned studies and has operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities as described in GCO procedural documents. The Senior Local Trial Manager (Sr. LTM) is responsible for coordinating and leading the local trial team to deliver quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements.The Senior Local Trial Manager (Sr. LTM) actively contributes to process improvement; training and mentoring of Clinical Trial Assistants (CTA), Site Managers (SM) and LTM I roles. The Senior Local Trial Manager (Sr. LTM) may have some site management responsibilities. The Senior Local Trial Manager (Sr. LTM) may also perform the role of Clinical Trial Manager (CTM)/Global Trial Lead (GTL) for single country as described in GCO procedural documents.Principal Responsibilities:
Collaborate with Functional Manager (FM)/Clinical Research Manager (CRM) and Feasibility Process Leader or Global Feasibility Leader (GFL) for country protocol feasibility (if applicable) and site feasibility assessment in conjunction with the Clinical Trial Assistant (CTA) (if applicable), Site Manager (SM) and CTM/GTL. Implement any local criteria for site selection. Ensure consistent conduct of pre-trial assessment visits and instruct teams on appropriate follow-up of pre-trial visit report and country feasibility report. Recommend suitable sites for selection to participate in trial.
Collaborate with the Global Program Leader (GPL), CTM/GTL, local management/Country Head and other study team member to select final site list.
Contribute input to the study management documents at a country level or initiates development of these documents for a single country trial, as per SOPs.
Lead and coordinate local trial team activities in compliance with SOPs, other procedural documents and applicable regulations.
Lead local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget. Including, but not limited to: development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
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.
Maintain and update trial management systems. Use study tools and management reports available to analyze trial progress.
Monitor country progress and initiate Corrective and Preventive Action (CAPA) when the trial deviates from plans and communicates study progress and issues to study management teams.
May submit requests for vendor services and may support vendor selection.
In certain situations, may assist in negotiation of trial site contracts and budgets. Forecast and manage country/local trial budget to ensure accurate finance reporting and trial delivered within budget. Adhere to finance reporting deliverables and timelines.
Attend/participate in Investigator Meetings as needed. May schedule and conduct a local/country investigator meeting.
Conduct local trial team meetings and provide or facilitate SM training when needed (i.e. implementation of study amendment-and changes in study related processes).
Review and approve Monitoring Visit Reports submitted by SM and identify issues and/or trends across a trial project and escalates deviation issues to the CTM/GTL and Functional Manager (FM), as needed.
Review and approve site and local vendor invoices as required. Manage local study supply, as required.
Prepare country specific informed consent in accordance with procedural document/templates. Review and manage site specific informed consent forms in accordance with SOPs, other procedural documents and applicable regulations.
Organize and ensure Independent Ethics Committee (IEC)/Health Authority (HA) approvals, if applicable, and ensure that the trial is in compliance with local regulatory requirements.
Work with SM to ensure CAPA is implemented for audits and inspection or any quality related visits.
Comply with relevant training requirements.
Act as subject matter expert for assigned protocols. Develop strong therapeutic knowledge to support roles and responsibilities. May represent GCO on cross functional teams.
Act as primary local/country contact for a trial. Establish and maintain excellent working relationships with external stakeholders, in particular investigators, study trial coordinators and other site staff; and internal stakeholders, including Medical Affairs and Marketing for Medical Affairs trials.
Actively contribute to process improvement, training and mentoring of CTAs, SMs and other LTMs.
Conduct accompanied site visits with SM as delegated by FM.
May assume additional responsibilities or special initiatives such as “Champion” or “Subject Matter Expert”.
May represent functional area in process initiatives as required.
Qualifications
A minimum of a Bachelor’s degree is required, preferably in a Health, Science or Nursing discipline.
Required:
A minimum of 2 years of pharmaceutical industry and/or clinical trial experience.
Experience with Oncology clinical trials.
Knowledge of the drug development process, including Good Clinical Practices (GCPs) and FDA Code of Federal Regulations.
Project management experience.
Strong computer skills in appropriate software applications and related clinical systems.
Must have strong written and oral communication skills.
Must have solid leadership skills.
Must have a flexible mindset with the ability to work in a fast-changing environment.
Minimal business travel (meetings, training, etc.) is required.
Preferred:
Experience with CAR-T (Cell and Gene Therapy).
Experience with Hematology
Experience mentoring/coaching and providing training to others.
The ability to work on multiple trials in parallel.
The ability to lead initiative/small teams.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.The anticipated base pay range for this position in the San Francisco Bay Area, CA is $101,000 to $162,725. The anticipated base pay range for this position in all other US locations is $88,000 - $141,450.The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).Employees are eligible for the following time off benefits:
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
Additional information can be found through the link below. For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefitsPrimary Location NA-US-New Jersey-RaritanOther Locations NA-United StatesOrganization Janssen Research & Development, LLC (6084)Relocation Eligible: NoJob Function Clinical Trial Project ManagementReq ID: 2406173469W
