Study Implementation Lead

Takeda•Cambridge, MA

2d•$154,400 - $242,550

About The Position

This Associate Director-level role leads the planning, implementation, execution, and delivery of clinical studies and evidence-generation activities across a diverse portfolio of research programs. The position ensures studies are operationally feasible, compliant, and delivered in line with agreed quality, timeline, budget, and performance expectations. Working in a matrixed environment, the Study Implementation Lead collaborates with cross-functional teams and external partners to support study execution and continuous improvement. The role also advances operational excellence through the appropriate use of digital and artificial intelligence-enabled capabilities that strengthen planning, oversight, analytics, efficiency, and evidence-based decision-making while maintaining compliance, data privacy, and quality standards.

Requirements

Advanced degree in a scientific, clinical, epidemiologic, quantitative, public health, or related discipline.
At least 8 years of experience in clinical development, evidence generation, clinical operations, clinical research, or related environments involving interventional and non-interventional studies.
Strong experience in clinical operations, real-world evidence generation, or related clinical research environments.
Demonstrated experience managing clinical study implementation, including start-up, execution, close-out, and reporting activities.
Working knowledge of good clinical practice, applicable regulatory requirements, quality standards, and standard operating procedure-driven clinical research practices.
Experience developing and managing study plans, timelines, budgets, forecasts, resources, and operational risk mitigation strategies.
Experience overseeing vendors, contracts, and external provider performance.
Strong project management, stakeholder management, negotiation, communication, problem-solving, organizational, and team leadership skills.
Experience using clinical study systems, digital tools, analytics platforms, and artificial intelligence-enabled capabilities in a regulated environment.

Responsibilities

Lead implementation activities for assigned studies and programs across the evidence-generation portfolio.
Develop and manage study plans, including timelines, budgets, resource forecasts, enrollment strategies, and operational risk mitigation plans.
Oversee study execution and reporting through start-up, activation, conduct, close-out, and reporting in alignment with approved plans.
Monitor study quality, timelines, budgets, milestones, resources, and operational indicators, and address identified risks.
Manage vendors and external partners to ensure delivery against study objectives, contractual commitments, quality expectations, and timelines.
Maintain compliance with study protocols, regulations, quality standards, and standard operating procedures.
Lead cross-functional teams and partnerships to enable effective study delivery, issue resolution, and operational decision-making.
Drive process improvement and innovation through implementation excellence, standardization, coaching, and responsible adoption of digital and artificial intelligence-enabled solutions.