Senior Clinical Trial Manager - Oncology/Hematology in Summit, NJ at Apex Life Sciences

Date Posted: 10/20/2018

Job Snapshot

Job Description


  • The Sr. Clinical Trial Manager provides strategic and operational leadership of clinical research studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities’ regulations/guidelines, and applicable SOPs/WPs.
  • 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) teams. 


Responsibilities:

Financial Planning and Management: 

  • 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. 

Project Management:

  • 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 

Study Planning and Conduct:

  • 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
  • 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. 

Relationship Management 

  • Development/maintenance of collaborative relationships with: 
    • Internal partners/stakeholders including Clinical Research, Project Management, CR&D Operations, and Affiliates external partners including Contract Research Organizations (CROs), Academic Research Organizations (AROs), and other clinical service providers.

Requirements:

  • BA / BS or higher degree in relevant discipline 
  • Minimum 6 years clinical study management (study manager, study leader, clinical manager) experience at a CRO or Pharma/Biotech
  • At least 2 years direct multinational study management experience; experience leading a cross-functional protocol implementation team through all aspects of study conduct. 
  • Minimum of 2 years’ experience in oversight of CRO for clinical study execution. 
  • At least 2 years recent experience in hematology/oncology studies 

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EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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