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About the role
- Senior Local Trial Manager at Johnson & Johnson managing clinical trials with oversight on quality and compliance. Lead local trial teams to ensure successful study execution and data integrity.
Responsibilities
- Responsible for local management of a clinical trial in a country or countries.
- Act as the 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 that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements.
- Actively contribute to process improvement; training and mentoring of Clinical Trial Assistants (CTA), Site Managers (SM), and Associate Local Trial Managers.
- May perform the role of Trial Delivery Manager (TDM)/Trial Delivery Leader (TDL) for single country.
Requirements
- A minimum of a BA or BS degree in Pharmacy, Nursing, Life Sciences or related scientific field 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.
- Good understanding of the drug development process including GCP and local regulatory requirements.
- 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.
- Some experience in mentoring/coaching and providing training to other LTMs, SMs, and CTAs preferred.
Benefits
- medical
- dental
- vision
- life insurance
- short- and long-term disability
- business accident insurance
- group legal insurance
- consolidated retirement plan (pension)
- savings plan (401(k))
- up to 120 hours of vacation per calendar year
- up to 40 hours of sick time per calendar year
- up to 13 days of holiday pay including floating holidays
- up to 40 hours of work, personal and family time per calendar year
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