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Oncology Clinical Trial Manager

New Jersey All, New Jersey

Post Date: 06/15/2017 Job ID: JN -062017-19289 Industry: Clinical Project Management - Clinical
  • Provide oversight of a study to ensure progress according to study timelines and budget
  • Possibly lead or be a support trial manager for a study team
  • Support the study team including representatives from CSUs/affiliates/CROs, GPE, Medical Operation, Biostatistics, Clinical Supplies Platform, Regulatory, Pharmacokinetics and other relevant departments) for the operational aspects of the study
  • Liaise with clinical purchasing to prepare the RFP (request for proposal), review vendors specifications and oversee vendor activities and deliverables (i.e., Central Lab, IVRS, data management, external reviewer/adjudicator, meeting planners, ePRO, couriers, etc.)
  • Liaise with coding and clinical application representatives when applicable
  • Ensure proper documentation/availability
  • Contribute to the extended synopsis, protocol, amendments, and WSI (operational sections) development and review to ensure operational feasibility; Definition of the Case Report Form content and testing of the end product
  • Develop study-specific procedures and write the Monitoring Plan, contribute to the CRF completion guidelines, the Data Review & Surveillance Plan and/or other operational documents in conjunction with the STM
  • Review other CTT and vendor-developed or co-developed documents (e.g., specifications, scope of work, operational manuals, communication plans, retention and recruitment plans, data transfer plans, etc.) as requested to provide operational input (including on-time and high quality)
  • Ensure that clinical and data management standards are followed for the study
  • Ensure proper collection and validation of data and documentation on a timely manner
  • Assure proper overview and communicate to teams (including on-time and high quality) of monitoring activities, data flow, data validation and when applicable, coordinates the centralized review of procedures
  • Perform patient data validation homogeneously and fulfilling required quality standard
  • Ensure study documentation is properly maintained and archived in the Trial Master File (TMF) and relevant E-rooms and databases as required
  • Organize study specific meetings (STM excluded)
  • Coordinate and support field-monitoring activities through regular meetings: teleconferences and/or visits; training of monitoring teams, investigator meetings
  • Prepare and lead data review meeting, organize and contribute to medical review meetings
  • Collect, synthesize and report study information
  • Maintain and provide information for monthly study highlights (including enrollment curves and timelines) on a timely manner
  • Investigational Product (IP) Management
  • Collaborate with the TSOM to validate study IP needs, specifications, packaging, shipment (including resupply) and reconciliation process
  • Participate in the development/follow-up of the study budget and selection and management of vendors
  • Define needs, tasks and responsibilities of external vendors, review contracts, estimate costs of logistical aspects of the study and ensure tracking payments for operational aspects of the study are done, in collaboration with the Clinical Purchasing department
  • Preparation and oversight of study audits/inspections both internal and external
  • Provide oversight and preparation for FDA pre-approval inspections (PAI)
  • Bachelor's degree (advanced degree preferred)
  • At least 7 years of Clinical Trial management experience
  • At least 5 years experience in Oncology is mandatory
  • Needs to be able to review and validate patients and data
  • Experience in managing and leading international meetings (Clinical Trial Team, expert meeting, etc.)
  • Ability to work in an international environment with internal and/or external partners

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