Associate Director, Clinical Operations in Basking Ridge, NJ at DSI

Date Posted: 7/20/2020

Job Snapshot

Job Description

Job Summary:

The incumbent will be responsible for ensuring execution of clinical studies across geographic regions, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.

The Associate Director is accountable for operational planning and execution at the study level with responsibility for clinical study plan and execution (from planning start-up, conduct, reporting and close out) including timeline, quality and budget. A key focus will be the oversight of and interactions with CROs and other 3rd party vendors to ensure study milestones and deliverables are achieved according to agreed quality standards and timelines and that quality of data is suitable for regulatory submission.

The AD will have interaction with key internal and external stakeholders communicating project status, escalating issues, and troubleshooting routine inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are required and are equally important. Outside interfaces may include other Daiichi-Sankyo business groups and subsidiaries in the US and abroad, governmental, academic, community and industry organizations.
The role is primarily responsible for Operational Study Strategy and Study Execution and in addition may have the responsibility of managing 3 or more direct reports.

Study Management and Leadership
  • Primary accountability for operational study-level timeline, cost, and quality deliverables.
  • Lead the development of the clinical study plan including critical path activities and interdependencies for assigned clinical stud(ies) utilizing Microsoft Project or equivalent.
  • Lead the creation of the cross functional Clinical Study Oversight Plan (CSOP) under the guidance of the study team leader and take a leadership role in ensuring study team adherence to the CSOP and manage the overall implementation and documentation of the CSOP including activities conducted by CROs and vendors.
  • Provide operational input into study protocol profiles, final protocols and amendments
  • Lead document review and coordination for the protocol and amendments.
  • Lead the CRO/vendor selection process in collaboration with the study team and outsourcing procurement management. Lead the creation of the CRO scope of work in collaboration with Outsourcing Procurement Management.
  • Ensure adherence to internal procedures for study planning, study conduct, close out and reporting.
  • Proactively assess potential risks to the study and propose mitigation plans.
  • Monitor study budget against trial progress and bring deviations to the Operational program Lead and study team leader. Review and approve Vendor invoices, including investigator grants and pass through costs.
  • Ensure study budget is reconciled with Finance on an ongoing basis.

CRO, 3rd Party Vendor Management and Oversight
  • Responsible for the oversight, performance and management of CROs and 3rd party vendors to ensure compliance with Daiichi Sankyo’s quality measures and adherence to scope of work within timelines and budget at a task level. Specifically track operational study timelines and monitor operational performance metrics through the life of the study; Identify issues and propose solutions.
  • Responsible for overseeing CRO study start-up activities and coordinating with functional groups to ensure that essential site documents are collected, and sites are initiated per study plan.

Knowledge Management/People Management
  • This position may require the supervision of direct reports. In addition to providing instruction, direction of daily activities in support of goals, the supervisor will:
  • Manage all employee-related activities throughout the year, including performance management and development.
  • Identify and communicate the skills, behaviors and experiences required to develop employees.
  • Set goals, reviews performance and provides feedback on a regular basis.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:
  • 7+ years’ relevant experience with a BS degree is required. Experience in clinical operations methods and processes in industry setting required.
  • Experience considered relevant includes clinical research in a Pharmaceutical company, ARO or CRO. Clinical Project Management experience required. Familiarity with a Japan-based organization is desirable.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.