Lead Local Trial Manager - Oncology

Johnson & Johnson Innovative Medicine•Raritan, NJ

1d•$109,000 - $201,250•Remote

About The Position

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 jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. About Innovative Medicine 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 Johnson & Johnson Innovative Medicine R&D is recruiting for a Lead Local Trial Manager - Oncology. 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. The Lead 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. The Lead 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 Delivery Unit (DU) procedural documents. This individual will be 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. Actively lead or contribute to process improvement; training and mentoring of other LTMs and Site Managers (SM). Compared to Associate, Local Trial Manager and Senior, Local Trial Manager roles, a Lead Local Trial Manager is often assigned to more complex protocols and can work across Phase 1 - 3 studies in multiple therapeutic areas as needed to drive business needs. May also perform the role of Trial Delivery Manager (TDM)/Trial Delivery Leader (TDL) for single country as described in DU procedural documents.

Requirements

A minimum of a Bachelor’s degree in Pharmacy, Nursing, Life Sciences, or related scientific Discipline is required.
A minimum of 6 years of clinical trial management and/or clinical trial monitoring experience is required.
A minimum of 4 years of leadership experience is preferred.
Experience in the Oncology Therapeutic Area is required.
Must have excellent written and oral communication skills
Must have the ability to be consistently influential.
Must have a flexible mindset with the ability to work in a fast-changing environment.
The ability to work on multiple trials in parallel in different disease areas is required.
The ability to anticipate obstacles and proactively provide solutions is required.
Willingness to travel with occasional overnight stay away from home.

Nice To Haves

In-depth understanding of the drug development process, including Good Clinical Practice (GCP) and local regulatory requirements, is preferred.
Strong experience in mentoring/coaching and providing training to others (i.e. LTMs, SM, CTAs) is preferred.
Strong computer skills in appropriate software applications and related clinical systems required.
The ability to lead initiative/small teams is preferred.

Responsibilities

May be delegated by Functional Manager (FM)/Clinical Research Manager (CRM) to lead country protocol feasibility (if applicable) and site feasibility assessment in conjunction with CTA (if applicable), SM and TDM/TDL. Implement 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. Recommend suitable sites for selection to participate in trial. Collaborate with the Program Delivery Leader (PDL), TDM/TDL, local management/Country Head and other study team members 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. May be delegated by study team to initiate document development for global/regional studies.
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. Expected to guide Associate LTMs.
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. May be required to support Country Heads in generating country performance reports. Monitor country progress and initiate Corrective and Preventive Actions (CAPAs) when the trial deviates from plans and communicate study progress and issues to study management teams. May submit requests for vendor services and required to support vendor selection. May assist in negotiation of trial site contracts and budgets.
Forecast and manage country/local trial budget to ensure accurate finance reporting and trial is delivered within budget. Adhere to finance reporting deliverables and timelines. Expected to guide Associate LTMs. Attend/participate 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. May be required to be the organizer for Investigator Meetings.
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). May be required to provide guidance to Associate LTMs. Review and approve Monitoring Visit Reports submitted by SM, identify issues and/or trends across a trial project and escalate deviation issues to the TDM/TDL and FM/CRM as needed. Expected to mentor and guide Associate LTMs. Review and approve site and local vendor invoices as required. Manage local study supply, as required. Expected to guide Associate LTMs.
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. Expected to guide Associate LTMs. 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. Expected to guide Associate LTMs.
Work with SM to ensure CAPA is implemented for audits and inspection or any quality related visits. Comply with relevant training requirements. Acts as subject matter expert for assigned protocols. Develop strong therapeutic knowledge to support roles and responsibilities. May represent DU 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, SMs and other LTMs. May be asked to conduct accompanied site visits with SM as delegated by FM/CRM. May be required to provide guidance to Associate LTMs. Expected to assume additional responsibilities or special initiatives such as “Champion” or “Subject Matter Expert”. Expected to represent functional area or lead country, regional, and global process initiatives as required. Expected to be assigned to high priority and high complexity projects.

Benefits

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.
Subject to the terms of their respective plans, employees and/or eligible dependents are 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.
Subject to the terms of their respective plans, employees are 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.
Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation - 120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington - 56 hours per calendar year Holiday pay, including Floating Holidays - 13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

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