Local Trial Manager, Cross Therapeutic Area

at J&J Family of Companies in Springfield, Illinois, United States

Job Description

Local Trial Manager, Cross Therapeutic Area – 2406202060W

Description

Johnson and Johnson Innovative Medicine is recruiting for a Local Trial Manager, Cross Therapeutic Area. The position can be located anywhere within the United States.

The Local Trial Manager (LTM) is responsible for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. The Local Trial Manager (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 Local Trial Manager (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 Local Trial Manager (LTM) actively contributes to process improvement; training and mentoring of Clinical Trial Assistants (CTA) and Site Managers (SM). The Local Trial Manager (LTM) may have some site management responsibilities. The Local Trial Manager (LTM) may also perform the role of Clinical Trial Manager (CTM)/Global Trial Lead (GTL) for single country as described in GCO procedural documents.

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/ (https://www.jnj.com/).

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

Key Responsibilities:

+ 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 CTM/GTL. Implements 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. Recommends suitable sites for selection to participate in trial.

+ Collaborates with the Global Product Lead (GPL), CTM/GTL, 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 may 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

+ 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 CTM/GTL and FM 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, SM and other LTMs.

+ Conducts accompanied site visits with SM as delegated by FM.

+ May represents functional area in process initiatives as required.

Qualifications

Qualifications

Education:

+ A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.

Experience and Skills:

Required:

+ Minimum 1 to 2 years of pharmaceutical and/or clinical trial experience is required, however other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.

+ 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.

+ Some leadership, communication, and computer skills required.

+ Proficient in speaking and writing the country language of English.

+ Good written and oral communication skills

Preferred:

+ Retinal and/or Neuroscience experience.

+ Site monitoring experience.

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 eligi