[Hiring] Senior Trial Manager @Johnson & Johnson Innovative Medicine

Role Description

The Sr Trial Manager Early Development is responsible for the local management of a trial in one or more countries acting as the primary point of contact at a country level for assigned studies and for delivering quality data and trial documents/records that are compliant with assigned clinical protocol, codes of Good Clinical Practice (GCP), Healthcare Compliance Requirements (HCC), Standard Operating Procedures (SOPs) and local regulatory requirements.

• Performs Local Trial Manager (LTM) tasks including operational oversight of assigned protocol(s) from start-up to database lock and closeout activities.
• May perform Trial Delivery Leader (TDL) tasks for Early Development and Clinical Pharmacology (ED&CP) studies.
• May perform Site Manager (SM) tasks for ED&CP studies.
• Actively contributes to process improvement initiatives, and training and mentoring of SMs and Clinical Trial Assistants (CTA).

Qualifications

• A minimum of a BA or BS degree in Life Sciences (or equivalent experience) is required.
• Minimum of 2 years of clinical trial management experience preferred; other relevant experiences may be considered.
• Demonstrated AI literacy and an AI enabled mindset.
• Specific therapeutic area experience/knowledge may be required depending on the position.
• Good leadership skills and solid communication abilities.
• Proficient in speaking and writing the country language and English.
• Strong IT skills in appropriate software and company systems.
• Willingness to travel with occasional/regular overnight stays.
• Flexible mindset and ability to work at a fast pace within small exploratory international study teams.
• Ability to work on multiple trials in parallel in different disease areas.

Requirements

• Collaborates with the Functional Manager (FM) for study feasibility and site assessments.
• Ensures appropriate follow-up of pre-trial visit activities.
• Leads and coordinates local trial team activities in compliance with GCO SOPs.
• Ensures that all Serious Adverse Events (SAE)/Product Quality Complaints (PQC)/Suspected Unexpected Serious Adverse Reactions (SUSAR) are reported within timelines.
• Maintains and updates trial management systems.
• Monitors country and overall study progress and initiates corrective actions when necessary.
• May submit requests for vendor services and support vendor selection.
• Responsible for set-up and conduct of Investigator Meetings.
• Conducts trial team meetings and provides or facilitates SM training when needed.
• Ensures coordination of study supplies at country level.
• Prepares master informed consent and country specific informed consent(s).
• Works with SMs to ensure CAPAs are developed and implemented for audits.
• Acts as expert for assigned protocols and develops therapeutic area knowledge.
• May assume additional responsibilities or special initiatives.

Benefits

• Vacation – 120 hours per calendar year.
• Sick time - 40 hours per calendar year; varies by state.
• 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.
• Bereavement Leave – 240 hours for an immediate family member.
• Caregiver Leave – 80 hours in a 52-week rolling period.
• Volunteer Leave – 32 hours per calendar year.
• Military Spouse Time-Off – 80 hours per calendar year.