Assoc Director/ Sr. Manager, eCOA – FSP

Work Schedule

Environmental Conditions

Job Description

eCOA, Associate Director or Senior Project Manager, FSP

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.

Position: eCOA, Associate Director or Senior Project Manager, FSP

Location: Remote, US

Discover Impactful Work

Associate Director/Sr. Project Manager, eCOA, a subject matter expert in electronic Clinical Outcome Assessments (eCOA), drives process optimization, standardization, and operational excellence across clinical programs. Collaborating with our Sponsor and their internal team, while also working cross functionally to enhance & streamline in eCOA implementation.

A day in the Life:

This candidate will be providing strategic oversight, governance, and continuous process improvements, the eCOA Operations Lead ensures seamless delivery across many platforms

• Lead cross-functional teams in the development, optimization, and execution of eCOA frameworks to ensure efficiency, compliance, and seamless trial execution
• Serves as the lead between the sponsor and the organization at the project level.
• Establish and maintain governance and operational models to drive eCOA standardization, ensuring global consistency across the portfolio.
• Develop and implement process documentation and oversight frameworks for eCOA governance, ensuring alignment with regulatory expectations and internal quality standards
• On projects where the scope requires, ensures clear delineation in responsibilities and communication pathways for secondary project leads (such as lead in a specific region, lead for a specific vendor(s) or subset of delivery).
• Provide ongoing internal advisory support to key stakeholders, offering insights on eCOA advancements, challenges, and evolving regulatory landscapes
• Stay ahead of eCOA industry trends, regulatory updates, and technological advancements, proactively adapting strategies to maintain compliance and competitive advantage.
• Drives and leads the overall delivery of the cross-functional project.
• Ensures project team compliance with organization policies, SOPs, ICH- GCP, regulatory and project specific requirements.

Qualifications, Education & Skills Needed for this Role:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Expert knowledge of eCOA methodologies, regulatory guidelines(ICH-GCP, FDA, EMA)
• At least 5-8 Years of Project Management Experience
• Minimum 8 years of eCOA experience in clinical trials within the pharmaceutical or biotechnology industry, with direct eCOA implementation responsibilities.
• Proven expertise in system implementation, vendor management, and process development of eCOA.
• It is imperative to have a deep understanding of eCOA systems, technical implementations and operational workflows
• Strong project management and leadership skills
• In-depth understanding of clinical development processes and regulatory frameworks governing eCOA solutions.
• This candidate must possess excellent communication & leadership skills