Associate Clinical Trial Manager

$67,000 - $109,000/Yr

Exact Sciences - Madison, WI

Full-time - Mid Level

Madison, WI

Ambulatory Health Care Services

About the position

The Associate Clinical Trial Manager at Exact Sciences Corporation plays a crucial role in the Clinical Affairs Team, responsible for planning, executing, managing, and closing clinical study projects. This position involves managing clinical study operations, supporting multidisciplinary project teams, and ensuring compliance with clinical research regulations. The role requires strong organizational and communication skills to advocate for customers throughout the project lifecycle and to coordinate with various teams to achieve project goals.

Responsibilities

• Act as a customer advocate throughout the project lifecycle.
• Understand and support global project goals including site recruitment and patient recruitment.
• Implement approved clinical study protocols.
• Develop study-specific consent forms and other trial-related materials.
• Coordinate with cross-functional teams to identify goals and scope of clinical study projects.
• Manage and execute the overall project scope and timelines.
• Initiate and train sites to the study protocol; ensure proper site adherence to regulations.
• Manage resources and timelines associated with study start-up and implementation activities.
• Support the management and oversight of CROs and other clinical study-related vendors.
• Plan and manage all materials to support the execution of clinical projects.
• Ensure maintenance of document standardization through model documents and templates.
• Ensure appropriate development of all documents by CROs for assigned studies.
• Assume primary accountability for assigned clinical research projects and ensure compliance with regulations and guidelines.
• Develop and maintain project-specific tracking systems for study management and monitoring activities.
• Ensure operational and regulatory integrity of assigned studies and participate in inspections as needed.
• Prepare and distribute appropriate communications required to manage and document study activities.
• Facilitate the completion of database development, statistical analysis, and clinical study report writing.
• Manage relationships with consultants for data collection and analysis.
• Serve as a liaison between clients and internal teams to ensure proactive communication of project-specific information.
• Attend off-site meetings and conferences as needed.

Requirements

• Bachelor's degree in the life sciences or other applicable area.
• Minimum three years' experience in clinical research with at least one year of clinical research experience with sponsor/CRO.
• Clinical monitoring experience including data review and query resolution.
• Experience writing, reviewing, and editing protocols.
• Demonstrates knowledge of Good Clinical Practices and applicable US regulations governing clinical research.
• Excellent organization and communication skills.

Nice-to-haves

• Experience participating in the qualification and management of external vendors.
• Experience contributing to project operational teams through the start-up, study conduct, and data management.
• International study experience and GDPR implementation.

Benefits

• Paid parental leave
• Health insurance
• Dental insurance
• Paid time off
• Vision insurance
• Retirement plan