Lead Clinical Data Manager (20-00066) – NJ – Berkeley heights

Responsibilities :

  • Oversees DM activities across multiple trials across multiple sponsors/clients
  • Builds and maintains strong client/sponsor knowledge to ensure data management documentation consistency across client/sponsor trials (DMPs, CCGs, trial designs)
  • Oversees DM activities across trials for study start-up, conduct and finalization
  • Oversees DM activities for start-up including preparing the eCRF requirements/design/edit checks, CCGs, DMP
  • Oversees conduct activities related to ongoing review of clinical data listings (CRF, laboratory, SAE reconciliation, third party vendor and coding data) for quality, content and format
  • Oversees database finalization activities ensuring submission-ready quality data
  • Responsible for overseeing ongoing review of data, database maintenance and creation/ maintenance of study documentation to ensure it meets client/sponsor requirements and are consistent (if applicable)
  • Reviews status and progress reports with junior team members and mitigates as needed to ensure quality deliverables are on time
  • Responsible for coordinating/performing training and mentoring of new DM team members
  • Oversees DM initiatives, process improvements and innovation efforts in the spirit of continuous improvement in operational excellence
  • Cultivates effective working relationships with clients/sponsor and vendors
  • Reviews bids, contracts, change orders as needed
  • Authorizes database finalization (lock) for non-pivotal trials based on a review of the completion of all activities (under guidance of Group Head or above for pivotal trials)
  • Communicates effectively and persuasively negotiates with other team members, clients/sponsors
  • Consistently and efficiently monitors for data trends for previously unrecognized quality concerns, signals of potential fraud/misconduct, or any issues that arise regarding study management
  • Ensures DM team working on the client/sponsor trials are aware of the risks, priorities, goals, and impact of their work contribution
  • Performs reviews to ensure appropriate tracking systems are kept up to date and reviews outputs to ensure DM activities are progressing per plan and agreed upon timelines
  • Primary escalation point of contact for DM at the client/sponsor level
  • Plans appropriately to ensure adherence to timelines, identifies and proposes solutions to address resource and timeline issues and sets priorities for client/sponsor trials

Source: Job Diva – Job Listing

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