Manager Medical Study Operations

Responsibilities

• Manage multiple projects/programs, including Investigator-Initiated Studies (IIS), Research Collaborations, and Data Transparency, with moderate direction.
• Achieve alignment with Areas of Interest, completeness, and review by appropriate governing bodies.
• Obtain necessary approvals, including from the Medical Affairs Review Committee (MARC), Collaborator/Partners, and Senior Management, for both original proposals and amendments.
• Facilitate meetings and committees, setting agendas, driving goals, documenting outcomes, and ensuring follow-up on action items.
• Coordinate scientific meetings with external investigators and the Field Medical Team.
• Track and report study progress, data delivery, program impact, and other relevant metrics.
• Ensure collection, tracking, and archiving of all relevant documents, including regulatory submissions, IRB/EC approvals, and Health Authority communications.
• Ensure patent reviews, due diligence (e.g., OIG exclusion list, FDA debarment), and background checks for compliance.
• Collaborate with Site Budget & Contracting, Legal, Procurement, and Sponsor Institution to ensure agreement meets study requirements.
• Oversee study budgets, including Fair Market Value (FMV) analysis, approvals, and purchase orders (POs).
• Manage POs, achievements, invoicing, accruals, projections, and budget planning.
• Handle budget changes, reforecasts, and reconciliations while ensuring effective communication with partners.
• Plan and coordinate drug campaigns with Drug Supply Functions, ensuring compliance with packaging, labeling, and country-specific requirements.
• Manage drug shipments, resupply, expiry, quarantines, and destruction of unusable products.
• Ensure timely receipt and reconciliation of Serious Adverse Events (SAEs) and Investigator Alert Letters (IAL) in compliance with regulatory requirements.
• Coordinate internal review of publications, consolidate feedback, and document actions taken.
• Ensure data capture in study management tools and document repositories for audit readiness.
• Adhere to all relevant processes, training, and SOPs to ensure consistency, efficiency, and compliance.

Requirements

• A minimum of BA/BS degree in a related field with 7+ years of industry or relevant professional experience in clinical research.
• Experience in oncology and/or antibody research is a plus.
• Experience with Investigated Initiated Studies is preferred.

Qualifications

• BA/BS degree in a related field.
• 7+ years of industry or relevant professional experience in clinical research.
• Experience in oncology and/or antibody research.
• Experience with Investigated Initiated Studies.

Skills

• Project management.
• Proposal development and review.
• Regulatory compliance.
• Collaboration and facilitation.
• Scientific meeting coordination.
• Data management and reporting.
• Budget oversight and management.
• Drug supply function coordination.
• Regulatory compliance.
• Publication review and management.
• Data capture and audit readiness.
• Compliance with SOPs and processes.

Benefits

Includes a competitive and comprehensive total rewards package which may include:

• Annual bonuses or other incentive plans.
• Equity awards.
• Pension or retirement benefits.
• 401(k) company match.
• Health and wellness programs.
• Fitness centers.
• Insurance benefits (e.g. medical, dental, vision, life and disability).
• Paid time off.
• Family support benefits.

Pay

$114,800.00 - $187,400.00 annually

Schedule

On-site 4 days/week at Sleepy Hollow, NY offices.