Senior Clinical Trial Operations Lead

Deciphera Pharmaceuticals, Inc.; Waltham (MA); On-site; USD 115,000 - 159,000; Full time

Benefits offered by this job

Annual bonus

Medical, dental, vision insurance

401(k) retirement plan with company

Job summary

Deciphera Pharmaceuticals, Inc. seeks a detail-oriented Sr. Clinical Trial Associate (Sr.

CTA) to support the successful execution of clinical studies within Clinical Operations. You will partner with study leads and cross-functional teams to manage key components of trials, ensuring timelines, budgets, and quality standards are met. This fast-paced role offers opportunities to contribute to high-impact clinical programs, with responsibilities spanning study team management, documentation,

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.

Responsibilities

• 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.
• 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.
• 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.

Education

Bachelor’s or Master’s degree with at least 3 years of clinical operations experience in a pharmaceutical company and/or CRO

Job description

Deciphera Pharmaceuticals, Inc. seeks a detail-oriented Sr. Clinical Trial Associate (Sr.

CTA) to support the successful execution of clinical studies within Clinical Operations. You will partner with study leads and cross-functional teams to manage key components of trials, ensuring timelines, budgets, and quality standards are met. This fast-paced role offers opportunities to contribute to high-impact clinical programs, with responsibilities spanning study team management, documentation,