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Senior Clinical Trial Manager

New Jersey All, NJ

Posted: 01/25/2019 Job Type: Clinical Job Number: JN -012019-23506
Senior Clinical Trial Manager

Position has the potential to WFH 2 days a week after onboarding period of 1 month
  • Provides strategic and operational leadership of clinical research studies to ensure delivery on time, within budget, and of high quality
  • Responsibilities may include operational direction of one or more cross-functional study team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO) team
  • Development/management/reconciliation of overall study budget(s)
  • Development/management of vendor scope of work (SOW) per contract, quality, and budget
  • Review/approval of vendor invoices and management of accruals and SOW changes
  • Oversight of study execution utilizing available performance metrics and quality indicators
  • Oversight of clinical monitoring quality and adherence to established processes and plans
  • Development, management, maintenance of study deliverables [i.e. timelines, study plans, etc.] through collaboration with internal and external stakeholders
  • Proactive identification of potential risks and development/implementation of actions to avoid or mitigate
  • Maintenance/updating of data as appropriate in project management tools including CTMS
  • Informing operational program lead/s and other leadership (as appropriate) on overall clinical trial plans, updated forecasting, and of potential issues/mitigation
  • Facilitation of country and site feasibility/selection processes
  • Operational input into study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plan, Clinical Database edit specifications, Clinical Study Report (CSR) development, etc.
  • Oversight of investigational product [IP]supply forecasting/management and study-level IP reconciliation [in collaboration with IMSC]
  • Development of the subject recruitment/retention strategy and related initiatives
  • Participation in clinical service provider (vendor) selection, specification development, and management/oversight
  • Oversight of TMF set-up, ongoing quality review, and final reconciliation of study documents including review of site regulatory documents/packages and obtaining of appropriate country/site insurance
  • Development/coordination of study training for study team, investigational sites, and vendors
  • Oversight of required country regulatory (e.g. CTA, MoH) and country/site IRB/IEC approvals/notifications
  • Participation in Serious Adverse Event (SAE)reconciliation process
  • Experience with data cleaning and database closure coordination
Essential Experience Required:
  • BA / BS or higher degree in relevant discipline
  • Minimum of 6 years of Clinical Study Management experience
  • At least 2 years of direct global study management experience
  • Minimum of 2 years of CRO oversight experience
  • At least 2 years of recent experience in Hematology/Oncology studies
Skills/Knowledge Required:
  • Clinical Trial Project Management experience
  • Financial budgeting and forecasting skills
  • Leadership/influence management skills including stakeholder management and effective communication
  • In depth knowledge of ICH/GCP, regulatory guidelines/directives, and drug development and clinical research processes
  • Ability to effectively lead and direct a global cross-functional team in a matrix environment
  • Time management skills ability to effectively prioritize
  • Proven problem solving and decision making skills
  • Demonstrated success in using oral and written communication skills to influence, inform, or guide others
  • Solid computer skills requirement of MS applications including (but not limited to) MS Project, Word, Excel & PowerPoint
  • Study Tools including electronic system skills-CTMS / EDC/eTMF, etc.

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