Senior Trial Manager, Early Development, Oncology

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

📋 Description

• Oversee assigned clinical trials locally from initiation through database lock and closeout.

• Act as the primary local contact for the designated trials.

• Execute Local Trial Manager responsibilities and potentially Trial Delivery Leader and Site Manager duties.

• Perform feasibility studies and site assessments, recommending appropriate sites.

• Organize pre-trial activities and collaborate on final site selection.

• Create country-level study management documents, procedures, tools, recruitment strategies, risk management plans, and budget forecasts.

• Lead local trial teams and coordinate activities in accordance with GCO SOPs, GCP, HCC, regulations, and protocols.

• Ensure timely reporting and documentation of SAEs, PQCs, and SUSARs.

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

• Monitor study progress, initiate corrective and preventive measures, and escalate issues as necessary.

• Provide support for vendor services, vendor selection, invoices, site contracts, and budgets.

• Manage forecasts, finance reporting, and ensure delivery within budget constraints.

• Organize and conduct Investigator Meetings, collaborating on site initiation visits.

• Lead trial team meetings and facilitate training for Site Managers.

• Review Visit Reports and assist with analytical risk-based monitoring.

• Support data-entry action plans and oversee site recruitment activities.

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

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

• Organize IEC/HA approvals to ensure compliance with local regulations.

• Ensure that CAPAs are developed and implemented for audits, inspections, and quality visits.

• Serve as a protocol expert and develop knowledge in therapeutic areas and early development.

• Foster relationships with investigators, site staff, and internal stakeholders.

• Contribute to process improvements, training, and mentoring of Site Managers and Clinical Trial Assistants.

• Conduct accompanied site visits and assume champion or subject-matter-expert responsibilities as assigned.

⛳️ Requirements

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

• At least 2 years of experience in clinical trial management, alongside site monitoring experience, is preferred; other relevant experiences and skills may be considered.

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

• Proven AI literacy and an AI-enabled mindset, including the responsible use of AI tools.

• Specific therapeutic area experience or knowledge may be necessary.

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

• Proficient in both the local language and English, with strong speaking and writing skills.

• Strong IT skills in relevant software and company systems.

• Willingness to travel, including occasional or regular overnight stays.

• Capability to work at a fast pace within small exploratory international study teams.

• Ability to manage multiple trials concurrently across different 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 employees in Colorado; 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.

• 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.