14 days old

Project Coordinator

Kelly Services
Groton, CT 06349
Kelly Services is currently seeking a **Direct hire** **Project Coordinator** who will support Global Clinical Supply as it relates to transactional and project activities, assists to ensure the correct drug is in the right place and on time, for patients enrolled in clinical trials.

Salary BOE: $60k - $70k


+ Monitor the actual number of shipments to clinical sites and depots, comparing them to remaining supplies and announce anomalies to the Supply Chain Lead SCL.

+ Monitor the inventory of all bulk drug and finished kits throughout the course of the trial, ensuring drug is available for patients as and when required.

+ Maintain and reconcile customized supply chain management reports and Excel spreadsheets on a regular basis, monitoring actual to planned quantities.

+ Monitor expiry dates of all bulk drug and finished kits throughout the course of the trial and support the SCL, assisting in the generation of the plan for expiry updating or replacing clinical supplies when necessary.

+ Work with the SCL to determine a supply strategy for research trials. Including timing, quantities and packaging operations.

+ Work with Packaging operations to arrange packaging and labeling jobs.

+ Initiate drug shipments to trial sites globally and managing import/export expectations.

+ Prepare and verify inspection readiness documentation in preparation for regulatory inspections.

**Responsibilities include but are not limited to:**

+ Use tools and systems (e.g. CSDS, Clinicopia, M3, GMDS, PTMF) to provide transactional support. Activities may include, but are not limited to:

+ Creation of GMP documentation, such as Import Strategy Forms (ISF) and Stock Pack Requests (SPR),

+ Approval of High-Risk Data Change Requests (DCRs)

+ Searches for Certificate of Analysis (CoA)

+ Coordination of Label Expiry updates

+ Enter and verify information in CSDS

+ Track and create metrics on Suspected Quality Events (SQEs)

+ Ensure Training Compliance for Global Clinical Supply

+ Provides PTMF services.

+ Partner with Supply Chain Leaders (SCLs) to create and maintain Drug Plans and API trackers

+ Prepare and/or verify inspection readiness documentation in preparation for regulatory audits and inspections

+ Perform annual reviews on ongoing studies by verifying documents against items loaded to the PTMF system

+ Other projects as identified by the Operations Supervisor or GCS Operations Manager


Required Experience / Education:

+ High School Diploma/GED and equivalent work experience required

+ Bachelors with 6+ months customer and/or community service experience or an Associate degree with 2+ years work experience or HS / GED with 4+ years work experience

+ Working in ERP computer systems

+ Excellent customer service and communication skills with strong attention to detail Project management and/or operational/supply chain management experience preferred

+ Proficient use of Microsoft Word, and Outlook; Advanced Excel skills strongly preferred

+ Effective team work.

Preferred Experience / Education:

+ Bachelor's Degree in Science or business-related field preferred

+ Pharmaceutical or clinical supplies industry experience

+ Project management experience within a manufacturing environment preferred

**What our client can offer YOU upon hire!**

+ Full **medical, vision & dental** benefits the 1 st of the month after start date

+ **20 days** **of PTO** to start plus **12 holidays** per year

+ Company paid long and short term disability along with life insurance

+ **401k** company match

+ Professional development programs/ continuous learning opportunities

**What happens next**

Once you apply, you'll proceed to next steps if your skills and experience look like a good fit. But don't worry-even if this position doesn't work out, you're still in our network. Helping you discover what is next in your career is what we are all about.

**Apply to be a Print Screen Operator today!**

**Why Kelly** **** **?**

Youre looking to keep your career moving onward and upward, and were here to help you do just that. Our financial staffing experts will connect you with premier companies for opportunities where you can learn, grow, and thrive. Jobs that fit your skills and experience, and most importantly, fit right on your path of where you want to go in in your career. It all adds up.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2021-10-01 Expires: 2021-11-01

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Project Coordinator

Kelly Services
Groton, CT 06349

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