Job title: Senior Clinical Trial Associate
Company: Deciphera
Job description: Job DescriptionThe Role:The Senior Clinical Trial Associate (Sr. CTA) supports the management of the clinical trial from initiation to completion while partnering with internal and external cross-functional disciplines. The Sr. CTA assists in supporting the conduct and processes of trials including planning and execution of clinical trials and may be responsible for managing specific study and operational tasks.What You’ll Do:
- Perform quality control review of documents
- Perform sample management
- Maintain study trackers and tools as directed
- Assist study team with preparation for audits/inspections
- Track 1572s and liaise with Regulatory for IND submission as well as other essential documents as appropriate
- Responsible for filing documents in the Trial Master File for the study
- Responsible for agendas and meeting minutes for cross functional team meetings
- Support site start-up activities
- Perform Trial Master File (TMF) QC
- Assist in creating, editing, and distributing informed consent templates, manuals and other study documents
- Participate in review of study core documents (protocol, IB, CSR)
- Manage ancillary vendors
- Develop and maintain study documents
- Provide study-specific training and mentoring to CRAs and site staff
- Reviews clinical trial documentation including monitoring visit reports, monitoring plans, communication plan
- Participate and present at Investigator meetings as applicable
- Additional operations activities may be assigned as appropriate
- Perform administrative task on assigned clinical trials
- Demonstrates excitement around the Vison and Mission of Deciphera and the department
- Other duties as assigned
QualificationsWhat You’ll Bring:
- College degree in health sciences or related field is highly desirable. Relevant Training Certificate and/or other meaningful experience is mandatory
- A minimum of 3 years of relevant clinical operations experience in the pharmaceutical industry and/or CRO
- Demonstrates advanced knowledge of and appropriate experience of relevant software packages and Deciphera/vendor systems and programs
- Demonstrates thorough knowledge and understanding of key regulatory authorities, ICH Guidelines and GCPs
- Learns, interprets, and explains protocol requirements to others
- Manages components of clinical trials independently with limited general guidance from senior staff
- Demonstrates deep understanding of interdependencies of data, technology, vendor systems and metrics and differences across vendor abilities and responsibilities
- Strong verbal, written and presentation skills
Additional InformationDeciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $113,000.00 – $155,000. 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.
Apply Now: Join us in our mission to improve the lives of people with cancer. Apply today to become a part of our dynamic team!EQUAL EMPLOYMENT OPPORTUNITY INFORMATIONDeciphera 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.
Expected salary: $113000 – 155000 per year
Location: Waltham, MA
Job date: Sun, 18 May 2025 05:14:28 GMT
Apply for the job now!