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Clinical Trial Manager (Early Development)

New Jersey All, New Jersey

Post Date: 01/25/2017 Job ID: JN -012017-18192 Industry: Clinical Project Management - Clinical
  • Provide management and oversight of clinical trials (which may include complex, multiple center and multinational proof-of-concept studies) to ensure progress according to study timelines
  • Lead the Clinical Trial Team including representatives of all operational disciplines involved in the conduct of trial (i.e., CRAs/CROs, Data Management, Pharmacovigilance, Clinical & Exploratory Pharmacology Sciences, Biostatistics, Pharmacokinetics, Clinical Supplies, and other relevant departments, platforms or units)
  • Manage the study according to GCPs and local and/or national regulations, with responsibilities on product and project level
  • Collaborate with team members on a day-to-day basis; in particular, build a strong collaboration with the study Data Manager and the Clinical Study Director
  • Anticipate bottlenecks in all steps of the study and development/implementation of counteractive measures
  • Solve or coordinate the resolution of issues during conduct of the trial
  • Develop and review specific study-related documents
  • Develop and coordinate the study budget, including invoice validation
  • Contribute to contract process
  • Manage investigational product supplies (ordering, packaging, and shipment)
  • Participate in and contribute to internal audits, if applicable
  • Serve as main contact for clinical sites and other outsourced activities
  • Manage outsourced centralized activities when applicable (Central Lab)
  • May perform studies following some Phase II-III processes when applicable (multicenter-multi country Phase IIa trials)
  • Collect, synthesize, report, file and prepare archiving for clinical trial activities
  • Manage CRO/study sites
  • Escalate quality issues and delays in deliverables, propose solutions, request and ensure follow-up actions
  • Assess CRO performance by completing CRO post services assessments
  • Conduct yearly CRO assessment, if applicable
  • Manage outsourced/sub-contracted monitoring activities, when applicable
  • Lead study-specific training
  • Manage performance of monitors
  • Review and approve all visit reports
  • Conduct field monitoring activities, if required
    • Set-up and manage site visits (Site Initiation Visit, Interim Monitoring Visits, Closure Visit) including in-house preparation such as data listings review
    • Attend site visits as primary or co-monitor (e.g. when mentoring Associate CTMs)
    • Conduct source data validation and other monitoring activities (according to the study-specific Monitoring Plan, if applicable)
    • Use eCRF tool for ongoing data review and query generation
    • Regularly review and reconcile the Investigator Study File, Investigational Product accountability and biological sample management
    • Report visit progress/findings
    • If applicable, review visit reports
  • Participate to the mentoring and training/coaching of Associate CTMs, apprentices or trainees
  • Utilize department mentoring program
  • Track mentoring/training progress by meeting with mentee on regular basis
  • Participate in intra or inter-department Working Groups, if applicable
  • Propose and implement process improvements
  • Participate in development/improvement of guidance documents
Requirements:
  • Bachelor s Degree is required
  • 3 to 5+ years of Clinical Trial Management or Clinical Project Management is required
  • Field monitoring experience or related experience is required (approximately 3-5 years)



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