Trial Master File Associate Jobs in Cambridge, MA

We are seeking a detail-oriented and proactive Sr. Clinical Trial Associate (Sr. CTA) to support the successful execution of clinical studies within Clinical Operations. In this role, you will partner closely with study leads and cross-functional teams to manage key components of clinical trials, ensuring delivery against timelines, budgets, and quality standards.

This is an excellent opportunity for a clinical operations professional who thrives in a fast-paced environment and is eager to contribute to high-impact clinical programs.

Study Team & Meeting Management

• Coordinate cross-functional study team meetings, including agenda development and meeting minutes
• Support clinical site start-up activities and ongoing site management efforts
• Assist in managing external vendors and ensure alignment with study expectations
• Participate in, and occasionally present at, Investigator Meetings

Study Documentation, Tracking & Execution

• Maintain and track study documentation to ensure compliance with internal standards and regulatory requirements
• Support Trial Master File (TMF) management, including document filing and quality control
• Assist with development, editing, and distribution of key study documents (e.g., informed consent forms, manuals)
• Maintain study trackers, tools, and systems to support study execution

Study Planning & Quality Oversight

• Analyze clinical systems and processes to identify risks to data quality and integrity
• Provide input into protocol feasibility and identify opportunities to optimize study delivery
• Develop and manage study timelines, proactively identifying risks and escalating issues as needed
• Support clinical trial budgeting activities and cost tracking
• Track regulatory documents (e.g., 1572s) and collaborate with Regulatory on submissions such as INDs
• Support sample management and contribute to review of core study documents as applicable

Required Qualifications

• Bachelor's or Master's degree with at least 3 years of clinical operations experience in a pharmaceutical company and/or CRO
• Solid understanding of ICH guidelines, GCP, and key regulatory requirements
• Ability to independently manage assigned components of clinical trials with minimal oversight
• Strong attention to detail and organizational skills

Preferred Experience & Skills

• Experience working with clinical trial systems and vendor platforms
• Understanding of data, technology, and vendor interdependencies across clinical studies
• Strong verbal, written, and presentation skills
• Ability to problem-solve, prioritize, and manage multiple activities simultaneously

Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $115,000 - $159,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.

Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera's competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable)

Benefits:

• Competitive salary and annual bonus.
• Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.
• Generous parental leave and family planning benefits.
• Outstanding culture and opportunities for personal and professional growth.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION

Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially.  We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.