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Excellent job opportunity of Project Manager III, Bridgewater, NJ, 7666513
Ref No.: 18-08322
Location: Bridgewater, New Jersey
Start Date / End Date: 03/05/2018 to 12/31/2018
Job Title: Project Manager III (7666513)
Location: Bridgewater, NJ
Duration: 9 months        
Client: A Big Pharmaceutical Client
              
Duties:
  • This position continues to evolve and becomes increasingly more important for the continued support of the Client research and development projects, where parts of the activities are done externally. The management of outsourced activities in the field of preclinical safety area is the main focus in this role.
  • In collaboration with the business management office and the experts in the operational centers, the Outsourcing Coordinator will manage the preclinical safety activities that we outsource to third parties (CROs).
  • This role combines logistics and business aspects of outsourcing (negotiate quote, setup AEDs and POs, validate invoices etc.) with technical/scientific activities which makes this role an increasingly important interface between project teams, DSAR entities and external partners in order to ensure in-time quality support of the Client research and development projects.
  • The role needs strong collaboration with experts in the operational centers (DPEs, PLs, Toxicologists)
  • Act as the contact person with various Contract Research Organizations in order to facilitate any activities that are performed outside the company
 
Skills
  • The candidate must have a very good level of expertise in the processes involved in the management of preclinical safety activities at CROs (outsourcing).
  • The candidate should be an individual that finds interest in a wider scope on the outsourcing process to combine technical/scientific skills with interest in business process and logistics.
  • This includes but is not limited to the general knowledge and understanding in the preclinical safety field in combination with a good understanding of the business acumen and logistic aspects of the outsourcing process.
  • The candidate should have experience in monitoring studies dedicated to their discipline.  They should be aware of GLP concerns and capable of troubleshooting and identifying issues related to overseeing study activities at an external vendor.  They should also have the ability to work in a collaborative environment interacting with a number of clients and support groups in order to assure streamline processes with an emphasis on quality and timeliness.  The candidate should be capable of maintaining a solid vendor relationship and assuring that the needs of the study are satisfied and appropriately managed.  They should have strong verbal and written communication skills and be able to be very well organized.
  • The candidate should have a degree in the appropriate scientific discipline and should also have at least 4 to 6 years of experience in a pharmaceutical environment.
  • A very good understanding of underlying processes in studies, especially with respect to flow of information and the interaction between scientific and business processes.
  • A basic understanding of Development and Discovery research processes.
 Education:
  • All Business Aspects and Logistics Aspects of the Outsourcing Process.
  • Scientific and Study Oversight and Monitoring in collaboration with experts in OCs.
  • Transversal Outsourcing Activities à BMO
  • Interface with Procurement, Relationships with Vendors, Quality Audits and Animal Site Visits, Support to the Global Alliances (Covance, Charles River etc.), Seeking Operational Excellence, DSAR Global External Budget Management
  • Act as the contact person with various Contract Research Organizations in order to facilitate any activities that are performed outside the company
  • Developed and maintain a strong interactive relationship with the CROs in order to act in a partnership aspect
  • Interact closely with the DPE or Project leader responsible for the activities that have been selected to externally contracted
  • Working collaboratively with the CROs, assure that all studies are managed in respect to timelines, budget and quality deliverables
  • Assure all aspects necessary for contracting studies are in place.  This includes developing and maintaining a strong working relationship with Purchasing, Legal and other support functions. Help to develop RFQ (Requests for quotes/information), help to implement Legal Contracts, Develop Master Service Agreements with potential preferred vendors, setup AEDs (Workspaces) and Purchase Orders.
  • Monitor studies for their progress and quality related to the scientific integrity (shared with OC experts).  As much as possible, triage scientific issues before involving internal experts for situations that need to be addressed. Involve experts where needed.
  • Collaborate with Q&C to establish and perform audits and assure that selected CROs respect the quality assumed by Client. Provide key metrics to establish productivity and quality measurements of the outsourcing team
  • Participate in strategic management of outsourced studies and build processes to assist in interactions with universities, external experts, etc.
 
Interested candidates can share their most updated resume at ridhi.thapa@artechinfo.com or reach out to me at 973-295-4583