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Description:
Assist in the management of Good Clinical Practice (GCP) activities in the support of studies and projects across one or more clinical programs.
Assist and coordinate review and tracking of clinical investigator site or internal system/process audit responses and associated tasks across therapeutic areas.
Interact with Clinical Audit, Quality Assurance, and Operations teams and supporting functions to ensure quality compliance.
Escalate potential quality issues to management.
Support review of clinical audit responses for adequacy, consistency and compliance.
Support the clinical business partners in understanding audit response processes and use of technology.
Track the timelines of multiple audit responses to satisfactory completion.
Support the Clinical Quality Audit team with administrative and operational tasks, including managing communications and filing systems.
Maintain and update audit records and documentation to ensure accuracy and timely filing, and act as audit management system designee for data entry if needed.
Act as a super user for Audit Management System and provide technical support for audit-related applications.
Qualifications:
Bachelor's Degree in a physical science, life science, nursing, pharmacy, or equivalent experience desired.
Minimum of 4+ years of experience in Pharma industry; prefer Quality Assurance, R&D, Project
Management, Clinical Operations, or related field.
Root cause analysis and CAPA management
Demonstrate proven track record utilizing core and technical competencies in managing multiple projects; preferably in a clinical research or QA function.
Strong communication skills and work independently as well as part of a team.
Excellent skills in use of Microsoft applications (Excel, PowerPoint, Word, Visio) and database applications, such as TrackWise
Support businesses in understanding of audit response processes and use of technology such as navigating and entry into the audit management system.
Work independently as well as part of a team, and utilize strong communication skills
Benefits:
Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.
Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first of the month following at least 1 calendar year after employment begins.
Synectics is an equal opportunity employer.
Synectics is a leading staffing and workforce solutions company dedicated to connecting exceptional talent with top organizations. We specialize in IT, engineering, finance, healthcare, and professional services recruitment, offering both contract and permanent staffing solutions. With a people-first approach, we focus on understanding the unique needs of our clients and candidates to create long-term, successful matches. Our mission is to empower businesses with the right talent while helping professionals achieve rewarding career opportunities