Sr. Clinical Trial Associate
Waltham, MA - USA
Job Summary
We are seeking a detail-oriented and proactive Sr. Clinical Trial Associate (Sr. CTA) to support the successful execution of clinical studies within Clinical 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
Qualifications :
Required Qualifications
- Bachelors or Masters 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
Additional Information :
Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $115000 - $159000. 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 Decipheras 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.
Remote Work :
No
Employment Type :
Full-time