- Monitor the QE Mailbox for notifications from CROs and ensure timely acknowledgment and processing.
- Assist with forwarding QE notifications to relevant Moderna team members and stakeholders.
- Maintain accurate records of Major/Critical QE notifications and related documentation in the QE Mailbox Archive.
- Support the review and distribution process for QE notifications, ensuring correct team member engagement.
- Aid in communications between Moderna and CRO study team members for QE follow-up.
- Help document Quality Event information accurately in the Quality Documentation system.
- Work with clinical trial teams to process QEs in line with internal policies, global and local regulations, and ICH/GCP.
- Provide support to Clinical Compliance on clinical trial teams.
- Assist with questions or issues related to Quality Event management.
- Help study teams with the documentation of quality events and contribute to the investigation of issues and development of CAPA plans.
- Bachelor's degree required; Advanced degree a plus.
- Minimum of 5 years of experience in clinical research with a focus on clinical compliance.
- Strong written and oral communication skills.
- Working knowledge of GCP/ICH and other applicable regulations/guidelines.
- Good verbal and written communication skills.
- Ability to work on multiple projects in a dynamic environment.
- Effective collaboration skills in a cross-functional matrix environment.
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Sr. manager clinical compliance - Cambridge, United States - Randstad
Description
job summary:
The Role:
The Quality Events Specialist will be responsible for the operational management of Quality Events (QE) reported by CROs, focusing on ensuring these are addressed in accordance with company procedures. The individual will support clinical trial teams by providing expertise on QE management processes. The candidate will work with trial teams across different stages of drug development and multiple therapeutic areas, applying a solid understanding of internal procedures, policies, local and global regulations, and ICH/GCP. This role requires effective collaboration with cross-functional team members.
location: Cambridge, Massachusetts
job type: Contract
salary: $ per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
Here's What You'll Do:
Here's What You'll Bring to the Table:
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
Applications accepted on ongoing basis until filled.
