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Clinical Study Manager

New Jersey All, NJ

Posted: 09/21/2018 Job Type: Clinical Job Number: JN -092018-22616
  • Accountable for the day to day planning, executing and reporting, (from site feasibility up to and including study site close-out), of assigned Phase I-IV Global Drug Development (GDD) studies
  • Single point of contact and local study team lead, within the Country, for the assigned studies
  • Responsible for assuring aligned communication with Country Research Associates (CRAs), CRA Managers and other key Country associates on the execution and progress of their studies
  • Accountable to communicate with and support relationships with clinical investigators
  • Collaborates with Country medical/clinical trial colleagues on the execution and delivery of their assigned studies
  • Work with the CSM Team supporting allocation, initiation and conduct of trials
  • Support study feasibility and country patient commitments in collaboration with Country Trial Monitoring and Medical
  • Collects and manages input to the study protocol, and operational aspects of the study
  • Ensures that study start-up activities are conducted and completed on time, including preparation of IRB/EC submission packages, review of Informed Consent Forms, engaging Regulatory Affairs/CTA Hub for Health Authorities submissions, as required, in collaboration with Country/Cluster Trial Monitoring stakeholders
  • Supports in local Drug Supply Management, to forecast local IMP and comparator needs as appropriate
  • Ensures IMP is available to commence and complete assigned trial/assigned trial sites
  • Oversees local vendor performance as needed
  • Serves as main contact for quality/compliance issues, escalating as necessary
  • Ensures sites are prepared for Ready to Initiate Site (checkpoint), inclusive of written confirmation, and ensures all documentation is in place for initial and subsequent drug release in collaboration with the local Qualified Person(s)
  • Maintains a strong knowledge of the study protocol to answer standard operational questions from CRAs, sites, and internal Country/Cluster personnel
  • Supports the conduct of the study, (tracks status, maintains study level reporting systems, oversees forecasts, progress, and mitigation plans), to ensure all study operational aspects are on track
  • Ensures recruitment targets are met and reviews enrollment at the site level including responsibility for approval of enrolling above site targets
  • Responsible to set up contingency plan to ensure recruitment targets are achieved in accordance with trial execution plan
  • Works with CSM team to oversee local clinical team activities to achieve study timelines and quality execution, (proposing and implementing corrective actions where appropriate)
  • Supports Leads/chairs at local study team meetings or supports Sr. CSM in the conduct of local study team meetings, participates in global clinical trial team meetings, as required and is the single point of contact for the conduct of assigned studies or study sites
  • Maintains oversight of country level or assigned site level data management activities, including timely understanding of screen failure reasons and discontinuation rates, review of patient profiles, and proactively identifies data entry issues (on quality and timing) to mitigate queries, proactively identifies query resolution issues
  • Coordinates the study handover process with the CRAs and their managers to ensure proper documentation and communication, when necessary
  • Tracks that all study close out activities are performed in a timely manner, in collaboration with CRAs and key study stakeholders
  • Delivery of quality data and compliance to quality standards
  • Supports coordination of training, as needed, for CRAs to support site readiness to recruit and study execution ensuring adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements
  • Supports local investigator meetings as needed
  • Ensures documentation of training (global/regional/local investigator meeting minutes, participants lists, certificates, etc.) is archived in the Trial Master File
  • Identifies and escalates potential challenges/risks within the protocol and operational aspects of the study; assessing impacts, developing risk management plans and communicating/ escalating to regions and/or global teams, as appropriate
  • Provides feedback about the quality of monitoring activities to CSM Group Head or Sr. CSM as appropriate
  • Supports inspection readiness and submission preparation for monitoring related activities and assists and coordinates with Sr. CSM or CSM Group Head for internal audits organization and HA inspections, as required, and ensures implementation of corrective actions within specified timelines
  • Supports as needed, taskforces to support continuous improvement initiatives
Requirements:
  • A degree in scientific or health discipline required and advanced degree with clinical trial experience and/or project management, is preferable
  • Minimum 3 years experience in clinical trial management in a role that oversees (project management)
  • Capable of working within in a matrix environment, without direct reports
  • Understanding of all aspects of clinical drug development with particular emphasis on monitoring and study execution
  • Strong project management capabilities with demonstrated ability to problem solve and mediate complex issues
  • Thorough understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMEA), local/National Health Authorities regulations
  • Experience with site intercommunications
  • Strong communication skills, written and verbal

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