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 plays a crucial role in the Clinical Affairs Team, focusing on the planning, execution, management, and closure of clinical study projects. This position is responsible for ensuring compliance with clinical research regulations, managing resources and timelines, and supporting multidisciplinary project teams to achieve global project goals related to cancer prevention and treatment.

Responsibilities

• Act as a customer advocate throughout the project lifecycle.
• Understand and support global project goals including site recruitment, patient recruitment, marketing, and PR.
• 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 clinical research regulations.
• Manage resources and timelines associated with all study start-up and implementation activities.
• Support the management and oversight of CROs and other clinical study-related vendors.
• Plan for and manage all materials to support the execution of clinical projects.
• Ensure maintenance of document standardization through model documents and templates.
• Ensure the appropriate development of all documents by CROs.
• Assume primary accountability for assigned clinical research projects and ensure compliance with regulations and guidelines.
• Ensure the development and maintenance of project-specific tracking systems.
• Ensure operational and regulatory integrity of assigned studies and participate in inspections as needed.
• Develop and maintain detailed timelines and resource projections for all programs.
• Prepare and distribute appropriate communications required to manage and document activities on the studies.
• 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/query resolution and protocol deviation tracking.
• 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 time off including vacation, holidays, volunteering, and personal time.
• Paid leave for parents and caregivers.
• Retirement savings plan.
• Wellness support.
• Health benefits including medical, prescription drug, dental, and vision coverage.