Senior Manager, Clinical Study Lead – Hematology

Role Overview

• The Senior Clinical Study Lead (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned large and/or complex clinical trials
• Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study
• Provides operational input into protocol development
• Oversees and provides input to the development of study specific documentation
• Oversees set-up and maintenance of study systems
• Ensures compliance with the clinical trial registry requirements
• Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors
• Provides input into baseline budget development and management
• Provides input into baseline timeline development and management
• Leads risk assessment and identifies risk mitigation strategies at the study level
• Leads the feasibility assessment to select relevant regions and countries for the study
• Oversees/conducts site evaluation and selection
• Leads investigator meeting preparation and execution
• Monitors progress for site activation and monitoring visits
• Leads the development of and oversees implementation of patient recruitment and retention strategies
• Monitors data entry and query resolution
• Ensures accurate budget management and scope changes for internal and external studies
• Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation
• Escalates issues related to study conduct, quality, timelines or budget to Program Operations Leader (POL)
• Contributes to clinical study report writing and review
• Facilitates and contributes to study level lessons learned
• Assigns tasks to Clinical Study Management staff and supports their deliverables
• Responsible for identification of innovative approaches to clinical study execution
• May require 25% travel

Requirements

• minimum of a Bachelor's degree
• minimum of 8 years relevant clinical trial experience
• Exceptional interpersonal & leadership skills
• Applies advanced expertise and implements the operational strategic direction and guidance for respective clinical studies
• Demonstrates expert knowledge and a data-driven approach to planning, executing, and problem solving
• Advanced communication skills via verbal, written and presentation abilities
• Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
• Ability to influence and negotiate across a wide range of stakeholders
• Strong budget management experience
• An awareness of relevant industry trends
• Ability to build, lead and develop productive study teams and collaborations
• Applies advanced negotiation and interpersonal skills to vendor management
• Advanced technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC
• Extensive experience in global clinical trial operations with unique knowledge and skills to contribute to the development of protocols and key study documents
• Knowledge of ICH/GCP and regulatory guidelines/directives
• Advanced project management skills, cross-functional team leadership and organizational skills
• Line management experience

Tech Stack

• Google Cloud Platform

Benefits

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave)