Senior, Local Trial Manager

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

R&D Operations

Job Sub Function:

Clinical Trial Project Management

Job Category:

Professional

All Job Posting Locations:

Albany, New York, United States of America, Albany, New York, United States of America, Albuquerque, New Mexico, United States of America, Athens, Georgia, United States of America, Baton Rouge, Louisiana, United States, Bismarck, North Dakota, United States, Boise, Idaho, United States, Boston, Massachusetts, United States of America, Burlington, Vermont, United States, Charleston, South Carolina, United States, Cincinnati, Ohio, United States of America, Colorado Springs, Colorado, United States of America, Columbia, South Carolina, United States, Concord, New Hampshire, United States, Coppell, Texas, United States of America, Des Moines, Iowa, United States, Dover, Delaware, United States, Elk Grove Village, Illinois, United States of America, Greenwich, Connecticut, United States of America, Helena, Montana, United States, Jackson, Mississippi, United States, Jacksonville, Florida, United States of America, Jefferson City, Missouri, United States, Lansing, Michigan, United States, Las Vegas, Nevada, United States {+ 23 more}

Job Description:

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine

We are searching for a Senior, Local Trial Manager to be located remotely within the United States.

This is a remote role available in all states within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.
 

Remote work options may be considered on a case-by-case basis and if approved by the Company.

Purpose:

A Senior, Local Trial Manager is a mid-level trial management role with typically at least 2 years of clinical trial management or 3-5 years fo clinical monitoring experience. This role 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 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 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 actively contributes to process improvement; training and mentoring of Clinical Trial Assistants (CTA), Site Managers (SM) and Associate, Local Trial Managers. The Senior, Local Trial Manager may have some site management responsibilities. The Senior, Local Trial Manager may also perform the role of Trial Delivery Manager (TDM)/Trial Delivery Leader (TDL) for single country as described in GCO procedural documents.

You will be responsible for:

• Collaborate with Functional Manager (FM)/Clinical Research Manager (CRM) for country protocol feasibility (if applicable) and site feasibility assessment in conjunction with CTA (if applicable), SM and TDM/TDL. Implements any local criteria for site selection. Ensure consistent conduct of Site Qualification Visits and instruct teams on appropriate follow-up of Site Qualification Visit report and country feasibility report. Recommends suitable sites for selection to participate in trial.
• Collaborates with the Program Delivery Leader (PDL), TDM/TDL, local management/Country Head and other study team member to select final site list.
• Contributes input to the study management documents at a country level or initiates development of these documents for a single country trial, as per SOPs.
• Leads and coordinates local trial team activities in compliance with SOPs, other procedural documents and applicable regulations. Leads 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.
• Ensures that all Adverse Events (AE)/Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate.
• Maintains and updates trial management systems. Uses study tools and management reports available to analyze trial progress.
• Monitors country progress and initiates corrective and preventive actions (CAPA) when the trial deviates from plans and communicates study progress and issues to study management teams.
• May submit requests for vendor services and required to support vendor selection.
• In certain situations, may assist in negotiation of trial site contracts and budgets. Forecasts and manages country/local trial budget to ensure accurate finance reporting and trial delivered –within budget. Adheres to finance reporting deliverables and timelines.
• Attends/participates in Investigator Meetings as needed. May schedule and conduct a local/country investigator meeting. Will be expected to present and lead specific sessions and to facilitate discussion groups.
• Conducts local trial team meetings and provides or facilitates SM training when needed (i.e. implementation of study amendment-and changes in study related processes).
• Reviews and approves Monitoring Visit Reports submitted by SM; identifies issues and/or trends across a trial project and escalates deviation issues to the TDM/TDL and FM/CRM as needed.
• Reviews and approves site and local vendor invoices as required. Manages local study supply, as required.
• Prepares country specific informed consent in accordance with procedural document/templates. Reviews and manages site specific informed consent forms in accordance with SOPs, other procedural documents and applicable regulations.
• Organizes and ensures IEC/HA approvals, if applicable, and ensure that the trial is in compliance with local regulatory requirements.
• Works with SM to ensure CAPA is implemented for audits and inspection or any quality related visits.
• Complies with relevant training requirements.
• Acts as subject matter expert for assigned protocols. Develops strong therapeutic knowledge to support roles and responsibilities. May represent GCO on cross functional teams.
• Acts as primary local/country 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 Marketing for Medical Affairs trials.
• Actively contributes to process improvement, training and mentoring of CTAs, SMs and other LTMs.
• May be asked to conducts accompanied site visits with SM as delegated by FM/CRM. May be required to provide guidance to Assoc LTMs.
• May assumes additional responsibilities or special initiatives such as “Champion” or “Subject Matter Expert"
• May represents functional area in process initiatives as required.

This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.

Principal Relationships:

• Primary Reporting Structure: Reports to a FM/CRM
• Primary interfaces: FM/CRM, CTA, SM, TDM/TDL, Study Responsible Physicians (SRP)/Study Responsible Scientists (SRS), Compliance Managers/Specialists, Local Safety Officer
• Other Internal Interfaces: R&D Country Head, Strategic Account Lead (SAL), Contracts & Centralized Services (CCS), R&D clinical team (e.g., SRP), data management and Medical Affairs (when applicable)
• External Interfaces: Health Authorities, Ethics Committees, Investigational sites, local vendors and others as required.

Education and Experience Requirements:

• A minimum of a BA or BS degree in Pharmacy, Nursing, Life Sciences or related scientific field (or equivalent experience) is required.
• Minimum of 2 years of clinical trial management experience or a total of at least 5 years of clinical trial monitoring and/or clinical trial management experience. However, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
• Immunology, Neuroscience, Retinal, Pulmonary Hypertension and/or Cardiovascular Metabolism Therapeutic Area experience is preferred.
• Solid understanding of the drug development process including GCP and local regulatory requirements is required.
• Willingness to travel with occasional overnight stay away from home.
• Minimum of 2 years of leadership experience. Computer skills required. Proficient in speaking and writing the country language and English language. Excellent written and oral communication skills. Demonstrated potential to be influential.
• Some experience in mentoring/coaching and providing training to other LTMs, SMs and CTAs preferred. The ability to lead initiative/small teams.
• Flexible mindset and ability to work in a fast-changing environment. Ability to work on multiple trials in parallel. Ability to anticipate obstacles and proactively provide solutions.
• May be assigned to high priority projects.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position in the US is $$89,000-$143,750.
 

The anticipated base pay range for this position in San Francisco Bay Area is $103,000 to $165,600.
 

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-benefits
 

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.  
 

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center  (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
 

#LI-Remote

The anticipated base pay range for this position is :

$89,000-$143,750

Additional Description for Pay Transparency:

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)). This position is eligible to participate in the Company’s long-term incentive program. 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 of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.