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Senior Associate Clinical Bioanalysis in Basking Ridge, New Jersey at DSI

Date Posted: 6/8/2019

Job Snapshot

Job Description

About Daiichi Sankyo Cancer Enterprise

The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA.

Job Summary:

This senior scientist/manager position is expected to interact and work with different functions and departments within DSPD, as well as liaison with laboratory vendor partners, for supporting and/or managing technically-associated logistical and administrative assignments. This position is expected to support all members within QCP for work flows such as contract execution, invoice resolution & financial forecasting, document management (eTMF, inspection readiness), project management, etc.

  • Work with OPM and external lab partners for contract execution on behalf of QCP. Assist the establishment of master service agreements and bundle contracts.
  • Responsible for invoice reconciliation on an on-going base on behalf of QCP. Support financial forecasting for partial or whole projects managed by QCP function representative
  • Provide project management support to various QCP work flows. Assignments can include, but not limited to, timeline management, laboratory sample management (tracking and reconciliation), data quality oversight.
  • Responsible for QCP document archiving in regulatory documentation repository (e.g. TMF, Submission Vault), perform periodic functional QC check, and support work streams related to NDA submission preparation, inspection readiness, etc.
  • Support non-project goals including process improvement work streams in QCP

  • Bachelor’s degree or Master’s degree in healthcare administration or related area
  • 3+ years industry experience. Direct work experience in clinical development is strongly preferred. The candidate should have experience in project management, contracting and document management.
  • The Project Coordinator is expected to work across different functions and departments internally, as well as liaison with vendor partners to support and ensure timely completion of project timelines and SOW. The position is expected to work closely with team members within QCP to minimize delays and maximize efficient project completion. Take ownership of multiple tasks pertaining to different investigational products simultaneously. Accountable to manage and be able to prioritize various tasks simultaneously.
  • Oversee contract execution for the group and ensure timely resolution of invoices and purchase orders. Assist with the establishment of master service agreements and bundle contracts. Financial forecasting for parts or whole of technical projects and reconcile vendor invoicing on an ongoing basis.
  • Responsible to provide project management support to achieve the scope of work and budget boundaries. Stay on top of sample analysis and report timeline status. Support sample tracking and reconciliation and work closely with the vendors for timeline management.
  • Responsible for supporting regulatory submission activities (NDA/BLA/MAA). Experience with regulatory documentation and trial master file management desired Periodically perform quality checks. Maintain team share sites and support data transfer activities.
  • Create and maintain sample collection procedures. Assist sample management activities.
  • Skills desired: multi-tasking and open to learning new skills. Excellence in communications. Fluent in using Microsoft office. Experience of laboratory work in pharmaceutical or contract research organizations. Analytical thinking and detail oriented. Intercultural understanding