Local Trial Manager - Oncology (1 of 2) - 2406173802WDescriptionJanssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Local Trial Manager - Oncology. This position can be located remotely within the United States.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, cardiovascular and metabolism, and pulmonary hypertension. Please visit http://www.janssenrnd.com for more information.The Local Trial Manager - Oncology will be responsible for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. This individual will be 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 Global Clinical Operations (GCO) procedural documents. Coordinate and lead 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. Perform principal responsibilities under the direct supervision of a Senior Local Trial Manager or Specialist Local Trial Manager and/or Functional Manager (FM)/Clinical Research Manager (CRM).Principal responsibilities will include:
Collaborate with FM/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 Clinical Trial Manager (CTM)/Global Trial Leader (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. This will include: 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 actions (CAPA) when the trial deviates from plans and communicate 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; identify issues and/or trends across a trial project and escalate deviation issues to the CTM/GTL and 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 GCO 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 compliant 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.
Qualifications
A minimum of a Bachelor’s degree is required, preferably in a Health, Science or Nursing (RN) discipline.
A minimum of 1 year of pharmaceutical industry and/or clinical trial experience is required.
Clinical operations experience is preferred.
Experience in the Oncology (Solid Tumor, Hematology) Therapeutic Area preferred.
Experience with CAR-T (Cell and Gene Therapy) is preferred.
Experience with Bi-Specific or Tri-Specific therapies preferred.
Experience with complex Oncology Hematology clinical trials (multiple cohorts) is preferred.
Clinical research experience in biomarker trial management is preferred.
Clinical research experience with site management models, such as Just In-Time, Rapid Activation and Satellite site trial start-up, and monitoring management, is preferred.
Knowledge of the drug development process, including Good Clinical Practices (GCPs) and FDA Code of Federal Regulations, is required.
Project management experience is preferred.
Strong computer skills in appropriate software applications and related clinical systems required.
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.
The ability to work on multiple trials in parallel is preferred.
Minimal business travel (meetings, training, etc.) is required.
The anticipated base pay range for this position in the San Francisco Bay Area, CA is $81,000 to $129,605.The anticipated base pay range for this position in all other U.S. locations is $70,000 to $112,700.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
For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefitsThis job posting is anticipated to close on March 25, 2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.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.Primary Location NA-US-New Jersey-RaritanOther Locations NA-United StatesOrganization Janssen Research & Development, LLC (6084)Relocation Eligible: NoJob Function Clinical Trial Project ManagementReq ID: 2406173802W
