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Senior Study Manager

New Jersey All, NJ

Posted: 02/23/2018 Job Type: Clinical Job Number: JN -022018-21009
  • Responsible for the planning, implementation and conduct of large, global, complex oncology clinical trials in Phase I-IV
  • Provides leadership within the department and makes recommendations with regards to the operational aspects of executing clinical development deliverables
  • Responsible for oversight and project management of individual studies as well as relevant program related activities with minimal supervision
  • Manage CROs, vendors and consultants that are involved with the clinical trial and program
  • Serve as the clinical operations point person managing protocol execution
  • Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines
  • Participate in program strategy meetings, ad hoc clinical operations initiatives and programs as assigned
  • Assist with training and mentoring of internal clinical operations staff
  • Assist in preparation of clinical documentation for IND submissions/updates as well as NDA submission and other regulatory submissions as appropriate
  • Oversees the review and approval of clinical monitoring visit reports and ensures that all outstanding follow-up items are closed out in a timely manner
  • Review and provide input for reports and clinical documents such as informed consent, clinical protocols, Investigator Brochure, yearly updates to the regulatory authorities and status updates
  • Manage escalation of study related issues and establish appropriate course of action with Senior Management
  • Liaises with the clinical supply chain lead to ensure forecasting of clinical and non-clinical supplies accurately reflects protocol/trial needs
  • Ensure that the Clinical Trial Master File (TMF) is set up and maintained appropriately throughout the trial
  • Conduct periodic reviews of the Trial Master File (TMF) to ensure compliance with ICH/GCP and company SOPs as well as ensuring all appropriate documents are filed
  • Participate and respond to Quality Assurance and/or regulatory authority inspection audits
  • Ensures quality clinical data review and data integrity for assigned clinical trial(s)
  • Leading, overseeing and participation in governance committees
  • In conjunction with legal group and/or CRO facilitate the development of clinical trial agreements and other relevant documents
  • Review and approve site budgets, manage clinical trial budgets, liaise with finance when financial reporting and projections are requested from management
  • Liaise with Strategic Clinical outsourcing and participate in CRO bid defense meetings and vendor selection activities to include: creation of scope of work, budgets, vendor performance and issue resolution
  • Reconcile and report vendor and site payments, and change orders ensuring accuracy and timely delivery to finance
  • Responsible for creating program-level budget(s)
  • Work cross-functionally to ensure clinical program timelines and goals are met
  • Provide study-specific mentoring and line management for junior team members, as appropriate
  • Assume leadership role in operational improvement initiatives (e.g. SOP development, training etc.)
  • Ensures the competencies and skills required for the Clinical team is consistent with the company defined requirements
  • Mentor junior team members to support development by delegating responsibilities, overseeing and supporting development plans
  • Conduct quarterly check-ins and year end performance appraisals for direct reports which includes providing ongoing and constructive feedback
Qualifications
  • Bachelor s degree
  • Minimum of 5-7 years of experience in Clinical Project Management
  • Prior experience managing people is needed
  • Oncology experience is require
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