Senior Trial Manager, Early Development, Oncology

This is a fully remote position, open to applicants in New Jersey.

📋 Description

• Oversee designated clinical trials within one or more countries, serving as the primary point of contact at the country level.

• Ensure the delivery of high-quality data and trial documentation that adheres to protocols, Good Clinical Practice (GCP), healthcare compliance standards, Standard Operating Procedures (SOPs), and local regulations.

• Provide operational oversight from the initiation of the study through to database lock and closure.

• Execute or assist with tasks related to the Trial Delivery Leader and Site Manager for Early Development and Clinical Pharmacology studies.

• Conduct feasibility studies and site evaluations, recommending appropriate sites for trials.

• Organize local trial teams, develop recruitment strategies, manage risks, plan contingencies, and forecast budgets.

• Report and document Serious Adverse Events (SAEs), Protocol Deviations (PQC), and Suspected Unexpected Serious Adverse Reactions (SUSARs) within designated timelines.

• Maintain trial management systems while analyzing trial progress through dashboards and reports.

• Oversee study progression, initiate corrective and preventive measures, and escalate issues as necessary.

• Assist with vendor services, selection processes, invoices, site contracts, and budget management.

• Organize and conduct investigator meetings and collaborate during site initiation visits.

• Train and mentor Site Managers and Clinical Trial Assistants.

• Review visit reports and support risk-based monitoring practices.

• Coordinate study supplies, ensuring proper handling and storage of clinical drug supplies.

• Monitor site recruitment efforts and create action plans for sites with low enrollment.

• Prepare and manage master, country-specific, and site-specific informed consent documents.

• Facilitate the organization of IEC/HA approvals while ensuring regulatory compliance.

• Assist in the development and implementation of Corrective and Preventive Actions (CAPA) for audits, inspections, and quality visits.

• Serve as the protocol expert and the primary local Global Clinical Operations (GCO) contact.

• Foster relationships with investigators, trial coordinators, site personnel, and internal stakeholders.

• Contribute to initiatives aimed at process improvement and conduct accompanied site visits.

• Take on additional responsibilities as a champion or subject matter expert as assigned.

⛳️ Requirements

• A minimum of a BA or BS degree in Life Sciences (or equivalent experience) is required.

• At least 2 years of clinical trial management experience, alongside site monitoring experience, is preferred.

• Prior clinical trial experience in Early Development and Clinical Pharmacology (ED&CP) is preferred.

• Proven proficiency in artificial intelligence (AI) and a mindset geared towards AI utilization.

• Capability to apply AI tools responsibly in daily tasks.

• Strong understanding of the drug development process, including ICH/GCP and local regulatory standards.

• Competency in both the local language and English, with good written and verbal communication skills.

• Robust IT skills with relevant software and company systems.

• Willingness to travel, including potential overnight stays away from home.

• Ability to work efficiently in a fast-paced environment within small exploratory international study teams.

• Capacity to manage multiple trials concurrently across various disease areas.

🏝️ Benefits

• Retirement plan (pension)

• Savings plan (401(k))

• Vacation – 120 hours per calendar year

• Sick time – 40 hours per calendar year; 48 hours for Colorado employees; 56 hours for Washington employees

• 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 birth/adoption/foster care of a child

• Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year

• 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

• Inclusive interview process and disability accommodations