[Hiring] Lead Local Trial Manager - Oncology @Johnson & Johnson Innovative Medicine

Role Description

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. 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.

• Primary point of contact at a country level for assigned studies.
• Operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities.
• Coordinate and lead the local trial team to deliver quality data and trial documents/records compliant with:
  • Assigned clinical trial protocol
  • Company Standard Operating Procedures (SOPs)
  • Good Clinical Practice (GCP)
  • Regulatory requirements
• Lead or contribute to process improvement; training and mentoring of other LTMs and Site Managers (SM).
• May perform the role of Trial Delivery Manager (TDM)/Trial Delivery Leader (TDL) for a single country.

Principal Responsibilities

• Lead country protocol feasibility and site feasibility assessment in conjunction with CTA, SM, and TDM/TDL.
• Ensure consistent conduct of Site Qualification Visits and instruct teams on appropriate follow-up.
• Collaborate with the Program Delivery Leader (PDL), TDM/TDL, and local management to select final site list.
• Contribute input to study management documents at a country level.
• Lead and coordinate local trial team activities in compliance with SOPs and applicable regulations.
• Ensure all Adverse Events (AE)/Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within required timelines.
• Maintain and update trial management systems.
• Monitor country progress and initiate Corrective and Preventive Actions (CAPAs) when necessary.
• May submit requests for vendor services and assist in negotiation of trial site contracts and budgets.
• Attend/participate in Investigator Meetings as needed.
• Conduct local trial team meetings and provide or facilitate SM training when needed.
• Review and approve Monitoring Visit Reports submitted by SM.
• Prepare country specific informed consent in accordance with procedural documents.
• Organize and ensure Independent Ethics Committee (IEC)/Health Authority (HA) approvals.
• Work with SM to ensure CAPA is implemented for audits and inspections.
• Acts as subject matter expert for assigned protocols.
• Establish and maintain excellent working relationships with external and internal stakeholders.
• Expected to assume additional responsibilities or special initiatives.

Qualifications

• 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.
• In-depth understanding of the drug development process, including GCP and local regulatory requirements, is preferred.
• Strong experience in mentoring/coaching and providing training to others is preferred.
• Strong computer skills in appropriate software applications and related clinical systems required.
• Excellent written and oral communication skills.
• Ability to be consistently influential.
• Flexible mindset with the ability to work in a fast-changing environment.
• Ability to work on multiple trials in parallel in different disease areas is required.
• Ability to lead initiative/small teams is preferred.
• Ability to anticipate obstacles and proactively provide solutions is required.
• Willingness to travel with occasional overnight stay away from home.

Requirements

• The anticipated base pay range for this position in the San Francisco Bay Area, CA is $125,000 to $201,250.
• The anticipated base pay range for this position in all other U.S. locations is $109,000 to $174,800.
• Eligible for an annual performance bonus based on individual and corporate performance.

Benefits

• Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Participation in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• Eligible for the Company’s long-term incentive program.
• Vacation - 120 hours per calendar year.
• Sick time - 40 hours per calendar year; 56 hours for employees in Washington.
• 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.