Associate Local Trial Manager, Immunology

Johnson & Johnson-posted about 1 year ago
$74,000 - $119,600/Yr
Full-time • Entry Level
Raritan, NJ
Chemical Manufacturing
Resume
Match Score
Upload and Match ResumeTrack Jobs with Teal

The Associate Local Trial Manager, Immunology is an entry-level role responsible for the local management of clinical trials within a country. This position serves as the primary contact for assigned studies, overseeing operational aspects from start-up to database lock and closeout. The role involves coordinating local trial teams to ensure compliance with clinical trial protocols, company SOPs, GCP, and regulatory requirements, while also contributing to process improvements and training of junior staff.

  • Collaborate with FM/CRM for country protocol feasibility and site feasibility assessment.
  • Implement local criteria for site selection and ensure consistent conduct of Site Qualification Visits.
  • Recommend suitable sites for trial participation and contribute to the final site list selection.
  • Lead and coordinate local trial team activities in compliance with SOPs and applicable regulations.
  • Manage local project planning activities to meet recruitment targets and deliver high-quality data on time and within budget.
  • Ensure timely reporting of Adverse Events (AE)/Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs).
  • Maintain and update trial management systems and analyze trial progress using available tools.
  • Monitor country progress and initiate corrective actions when necessary.
  • Assist in vendor service requests and support vendor selection.
  • Forecast and manage the local trial budget, ensuring accurate finance reporting.
  • Attend and participate in Investigator Meetings as needed.
  • Conduct local trial team meetings and provide training to Site Managers (SM) when necessary.
  • Review and approve Monitoring Visit Reports and escalate issues as needed.
  • Manage local study supply and review site-specific informed consent forms.
  • Organize and ensure IEC/HA approvals and compliance with local regulatory requirements.
  • Develop strong therapeutic knowledge to support roles and responsibilities.
  • A minimum of a BA or BS degree in Pharmacy, Nursing, Life Sciences or related scientific field is required.
  • Minimum of 2 years of pharmaceutical and/or clinical trial experience is required.
  • Basic understanding of the drug development process including GCP and local regulatory requirements.
  • Willingness to travel with occasional overnight stays away from home.
  • Good written and oral communication skills in the country language and English.
  • Specific therapeutic area experience is an added advantage.
  • Some leadership experience preferred.
  • Computer skills required.
  • Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
  • Consolidated retirement plan (pension) and savings plan (401(k)).
  • Vacation - up to 120 hours per calendar year.
  • Sick time - up to 40 hours per calendar year; up to 56 hours for employees in Washington.
  • Holiday pay, including Floating Holidays - up to 13 days per calendar year.
  • Work, Personal and Family Time - up to 40 hours per calendar year.
Track Jobs with Teal

Job Search Resources

•
Resume Builder
•
Resume Examples
•
Cover Letter Examples

Tools

Career Hubs

Guides

Company

© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service