Bridgewater Township, New Jersey

Clinical Supply Manager

 Kelly Services has provided outstanding employment opportunities to the most talented professionals in the marketplace. Today, we are proud to offer an excellent contract opportunity for a Clinical Supply Manager  with our client, a leader in the medical device industry, located in Bridgewater, NJ.

Can work remotely; but on site required on occasion- regional area candidates  

One year contract possible temp to hire

Supports the planning and organization of the working team and independently plans and organizes tasks to meet specified objectives and timelines. Manage the supply planning and delivery of development products by supporting clinical supply management, clinical supply packaging and labelling, IWRS, distribution, logistics planning and clinical supply budget development and tracking. Manage and execute the clinical supply chain for current and new clinical studies and programs.

This is a non-supervisory position

This role includes oversight of Clinical Development Manufacturing Organization(CDMO) vendors

Responsibilities 

  • Experience with any or all of the following functions or processes are highly preferred: clinical supply pack/label/distribution, clinical trial operations, project management, pharma/bio research and development, and inventory management.
  • Own the coordination and execution of all clinical supply related activities including supply planning, cGMP secondary packaging/labelling, distribution, and logistics for R&D clinical programs
  • Knowledge of clinical production processes and design strategy for patient kits to support the clinical study design.
  • Support the IWRS User specifications and UATs.
  • Execute clinical supply chain sourcing strategy utilizing 3rd party providers in coordination with clinical operations current and future programs
  • Coordinate supplier relationships with clinical supply vendors to which includes maintaining key performance metrics and budget/invoice tracking, reviews initial supply needs for start-up, ongoing resupply strategy, contract negotiation and amendments and closeout requirements
  • Evaluates vendor selection to support clinical studies according to capability and fit with outsourcing strategy and selection of contractors is made in agreement with line management. Generates RFPs for Vendor Proposals - Breakdown Protocols into component parts to support the supply strategy and communicate the study needs to obtain vendor based budgeting or internal support.
  • Addresses budgets and invoicing considerations with vendors along with study management details and capture any impacts.
  • Support business unit global supply chain in current and future clinical studies for clinical supply strategy and execution
  • Assist in the management of the governance committee for global clinical operations and global clinical supply chain
  • Work closely with supply chain colleagues to ensure consistency across processes and tools and implementation improvements to show sustainable results
  • Assist in the execution of clinical supply strategy for specific clinical programs
  • Understanding of the roles and responsibility of all functions represented on cross functional drug development teams.
  • Support of regulatory filings including IND submission information, regulatory audits and information to support regulatory audits. Provide regular updates to the TMF as per departmental and Corporate requirements that comply with all regulatory requirements.
  • Participate in clinical study team meetings, align with study details, and collaborate in meeting study objective, and provide supporting information to the teams (includes RA, RACMC, Clinical Operations, Manufacturing and Development)

Qualifications

  • Bachelor's Degree in science or business related field; Masters/MBA in Operations preferred
  • Minimum 7 years of experience handling / leading clinical supply chain and  logistics; some development experience preferred
  • Ability to rapidly navigate the organization and identify, align, and integrate cross-functional resources into cohesive teams
  • Demonstrated ability to work in a highly matrixed environment is essential; ability to develop and lead a high performing team across all levels
  • Experience in multi-functional areas (Clinical, Regulatory, Quality, Product/ProcessDevelopment) demonstrating a broad understanding of pharmaceutical development, both in GCP and GMP.
  • Expert knowledge of all phases of drug development, of the functions and processes relevant to drug development, and project management principles applicable to the biopharmaceutical environment
  •  Extensive in planning and execution of investigational materials supply strategies
  • General knowledge of GxP principles is required
  • Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch.  Applicants must be legally permitted to work in the United States


You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

Why Kelly®?

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re 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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

]]

Bridgewater Township, New Jersey

Why Kelly - Since 2011 we have placed over 16,000 Veterans

Need More?

Kelly applies targeted recruiting initiatives to the Veterans population (in all stages of transition) by aligning customer defined requirements with military skills and experience.  The transition from military to civilian life can be stressful and complex for veterans, and our staff is trained to assist in this transition.  Unlike our competition, Kelly places these resources without geographic or industry constraints, offering our customers and our employees greater flexibility.  Kelly has a wide variety of local opportunities, for Veterans and their spouses, within our workforce solutions as well as national recruiting programs on behalf of our customers.  Kelly’s leading placement opportunities for Veterans are within Information Technology, Engineering, Science, Light Industrial and Call Center.

Our specially trained Veteran recruiters are armed with a number of tools to help Veterans obtain roles that match their potential including skill translation tools, leading Veteran- centric job boards and Veteran/spouse social media networks, among others.

Through Kelly’s vast branch network, we are closely located to the majority of major military installations across the United States.  Kelly recruiters participate in onsite and virtual military career fairs as well as advertise through local and national Veteran job boards.  In recent years, over 150 Kelly branches have worked directly with their local military installations to recruit spouses and transitioning personnel.  These teams not only engages with transitioning talent from local bases, but also have a strong focus on Veterans in areas where the military has identified high Veteran unemployment. This approach ensures that military talent is engaged and shared across the centralized military recruiting team and documented in a centralized database, so that other Kelly locations can benefit from hiring or relocating this valuable pool of talent.

Our focus on military recruiting is a win on multiple levels. Kelly gains top talent with the skills needed to excel; our clients receive the benefit of that talent to help them compete in an ever challenging business landscape; and Veterans receive gainful employment in line with their skills and abilities to ease the transition to the next phase of their lives.

A People Company, Staffing the World

Kelly founded the temporary staffing industry in 1946, and has maintained a leadership position through the years based on a valuable premise: we invest in people. Today that focus benefits our customers wherever they operate around the globe - in a growing number of specialized fields. And we’ll continue to meet the evolving challenges of workforce flexibility with staffing solutions tailored to your precise business needs, both locally and worldwide.

Similar jobs