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Sr. Clinical Trial Associate
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Deciphera Pharmaceuticals
Waltham, MA (In Person)
$137,000 Salary, Full-Time
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Job Description
Job DescriptionWe 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 ManagementCoordinate cross-functional study team meetings, including agenda development and meeting minutesSupport clinical site start-up activities and ongoing site management effortsAssist in managing external vendors and ensure alignment with study expectationsParticipate in, and occasionally present at, Investigator MeetingsStudy Documentation, Tracking & ExecutionMaintain and track study documentation to ensure compliance with internal standards and regulatory requirementsSupport Trial Master File (TMF) management, including document filing and quality controlAssist with development, editing, and distribution of key study documents (e.g., informed consent forms, manuals)Maintain study trackers, tools, and systems to support study executionStudy Planning & Quality OversightAnalyze clinical systems and processes to identify risks to data quality and integrityProvide input into protocol feasibility and identify opportunities to optimize study deliveryDevelop and manage study timelines, proactively identifying risks and escalating issues as neededSupport clinical trial budgeting activities and cost trackingTrack regulatory documents (e.g., 1572s) and collaborate with Regulatory on submissions such as INDsSupport sample management and contribute to review of core study documents as applicableQualificationsRequired QualificationsBachelor's or Master's degree with at least 3 years of clinical operations experience in a pharmaceutical company and/or CROSolid understanding of ICH guidelines, GCP, and key regulatory requirementsAbility to independently manage assigned components of clinical trials with minimal oversightStrong attention to detail and organizational skillsPreferred Experience & SkillsExperience working with clinical trial systems and vendor platformsUnderstanding of data, technology, and vendor interdependencies across clinical studiesStrong verbal, written, and presentation skillsAbility to problem-solve, prioritize, and manage multiple activities simultaneouslyAdditional InformationDeciphera 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)
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.
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 ManagementCoordinate cross-functional study team meetings, including agenda development and meeting minutesSupport clinical site start-up activities and ongoing site management effortsAssist in managing external vendors and ensure alignment with study expectationsParticipate in, and occasionally present at, Investigator MeetingsStudy Documentation, Tracking & ExecutionMaintain and track study documentation to ensure compliance with internal standards and regulatory requirementsSupport Trial Master File (TMF) management, including document filing and quality controlAssist with development, editing, and distribution of key study documents (e.g., informed consent forms, manuals)Maintain study trackers, tools, and systems to support study executionStudy Planning & Quality OversightAnalyze clinical systems and processes to identify risks to data quality and integrityProvide input into protocol feasibility and identify opportunities to optimize study deliveryDevelop and manage study timelines, proactively identifying risks and escalating issues as neededSupport clinical trial budgeting activities and cost trackingTrack regulatory documents (e.g., 1572s) and collaborate with Regulatory on submissions such as INDsSupport sample management and contribute to review of core study documents as applicableQualificationsRequired QualificationsBachelor's or Master's degree with at least 3 years of clinical operations experience in a pharmaceutical company and/or CROSolid understanding of ICH guidelines, GCP, and key regulatory requirementsAbility to independently manage assigned components of clinical trials with minimal oversightStrong attention to detail and organizational skillsPreferred Experience & SkillsExperience working with clinical trial systems and vendor platformsUnderstanding of data, technology, and vendor interdependencies across clinical studiesStrong verbal, written, and presentation skillsAbility to problem-solve, prioritize, and manage multiple activities simultaneouslyAdditional InformationDeciphera 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.