Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Specialist, 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, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
The Specialist, Local Trial Manager (Specialist, LTM) will be responsible for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. The Specialist, LTM will be the primary point of contact at a country level for assigned studies and will have 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. Actively lead or contribute to process improvement; training and mentoring of other LTMs and Site Managers (SMs). This role can be assigned to more complex protocols, working across Phase 1-3 studies in multiple therapeutic areas as needed to drive business needs. May also perform the role of Clinical Trial Manager (CTM)/Global Trial Lead (GTL) for single country as described in GCO procedural documents.
Collaborate with Functional Manager (FM)/Clinical Research Manager (CRM) and Regional Therapeutic Areas Expert (RTAE) for country protocol feasibility (if applicable) and site feasibility assessment in conjunction with the Clinical Trial Assistant (CTA) (if applicable), 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 Product Lead (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 provides or facilitates 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 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 lead or contribute to process improvement, training and mentoring of CTAs, SM and other LTMs.
Conduct accompanied site visits with SM as delegated by FM.
Assume additional responsibilities or special initiatives such as “Champion” or “Subject Matter Expert”.
Represent functional area in process initiatives as required.
A minimum of an Associate’s degree or completion of a Nursing Program (RN) is required. A Bachelor’s degree in a Health or Science discipline is preferred.
A minimum of 4 years of pharmaceutical industry and/or clinical trial experience is required.
Clinical operations experience is preferred.
Experience in the Oncology Therapeutic Area is required.
Experience with CAR-T (Cell and Gene Therapy) 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.
Experience mentoring/coaching and providing training to others 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.
The ability to lead initiative/small teams is preferred.
Minimal business travel (meetings, training, etc.) is required.
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.
United States-New Jersey-Raritan-
North America-United States
Janssen Research & Development, LLC (6084)