Quality Control and Administration Manager, Clinical Supplies Systems at Randstad USA

job summary:

As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!

 
location: Princeton, New Jersey
job type: Contract
salary: $75.00 - 83.87 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:

The company is seeking a Quality Control and Administration Manager, Clinical Supplies Systems to perform quality control on documentation and financial-related administration. This person will be required to work with external IRT vendors (day-to-day operations and leadership capacity) to ensure the company's IRT systems align with internal stakeholders and timelines from business. This position will work collaboratively and cross-functionally to review documentation prior to upload to eTMF and work with external vendors on processing SOWs, COs, and Invoicing. The successful candidate is a subject matter expert at IRT-related finance, ability to review documentation with a keen eye, imaginative, skilled at understanding the needs of a clinical development operations organization with high attention to detail, a collaborative outlook, a positive leader, above no task, and the ability to pursue multiple options in parallel to meet project timelines 100% of the time.

• Ensure all operational documents are complete, accurate, and compliant with internal standards.
• Verify proper signatures and oversight are obtained at each step of the process.
• Process Statements of Work (SOWs), Change Orders (COs), and invoices with precision
• Maintain a state of 100% financial reconciliation and ensure on-time processing of invoices
• Collaborate with contracts and procurement teams to ensure timely processing of COs and SOWs
• Address and resolve any discrepancies or delays in contract processing
• Responsible for administration and uploading documentation to appropriate eTMF
• Perform routine budget reconciliations to ensure financial accuracy
• Prepare and present detailed financial reports to the Director of IRT
• Task assignments may expand in scope based on the individual's level of experience
• May be asked to participate in internal audits or external inspections

 
qualifications:

• At least five to eight years of financial reporting experience
• Bachelor's degree in a science-based or financial-based subject
• IRT Subject Matter Expertise
• Creative, capable problem-solver
• Experience in establishing and maintaining relationships with vendors
• Working knowledge of ICH, GAMP, FDA, IRB/IEC and other applicable regulations/guidelines and demonstrated understanding of clinical research protocol requirements
• Demonstrated proficiency with word processing, spreadsheet, database, presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint
• Successful candidate will be curious in exploring new path for clinical research, bold in proposing creative solutions and ideas.
• Will work collaboratively with multifunctional teams and partners and will be relentless in pursuing successful outcomes

 
skills: Quality control, MS-WORD, MS-EXCEL, MS-Powerpoint, Vendor Management, TMF, GMP (Good Manufacturing Practice)

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 HRsupport@randstadusa.com.

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).

This posting is open for thirty (30) days.