Covance

  • Study Start up Manager (SCRA level)

    Job Location(s) DE-Munich
    Job Number
    2018-25661
    Job Category
    Clinical Research Associate
    Position Type
    Full-Time
  • Job Overview

    At Covance, you’ll redefine what’s possible and discover your extraordinary potential. You’ll have the opportunity to personally advance scientific research and make a difference in peoples’ lives with your bold ideas and unique point of view. We are looking for a Clinical Operations Manager (Study Start Up) to be office based in Munich and working for one of our clients.

    Responsibilities:

    • Accountable for execution and oversight of local operational clinical trial activities for assigned protocols in compliance with ICH/GCP and country regulations, client policies and procedures, quality standards and adverse event reporting requirements internally and externally
    • Ownership of country and site budgets; development, negotiation and completion of Clinical Trial Research Agreements; oversight and tracking of clinical research-related payments; payment reconciliation at study close-out; oversight and maintenance of financial systems
    • Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols; development of local language materials including local language Informed Consents and translations; interactions with IRB/IEC and Regulatory Authority for assigned protocols
    • Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments; responsible for quality and compliance in assigned protocols in country; contribution to the development of local SOPs; overseeing Clinical Trial Coordinators as applicable
    • Coordinates and liaises with Country Research Manager, Clinical Trial Coordinator, Clinical Research Associate, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, Clinical Trial Research Agreements and local milestones; collaborates closely with Regional Operations to align country timelines for assigned protocols
    • Oversight and coordination of local processes; clinical and ancillary supplies management, im- and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management; enters and updates country information in clinical systems

    Requirements:

    • Degree in Sciences or equivalent experience in a similar role
    • Proven experience in a similar role within a CRO or Pharmaceutical company
    • English fluent written and oral
    • Ability to instruct and lead teams

     

    Education / Qualifications

    degree in life sciences OR equivalent experience in similar position

    Experience

    • Accountable for execution and oversight of local operational clinical trial activities for assigned protocols in compliance with ICH/GCP and country regulations, client policies and procedures, quality standards and adverse event reporting requirements internally and externally
    • Ownership of country and site budgets; development, negotiation and completion of Clinical Trial Research Agreements; oversight and tracking of clinical research-related payments; payment reconciliation at study close-out; oversight and maintenance of financial systems
    • Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols; development of local language materials including local language Informed Consents and translations; interactions with IRB/IEC and Regulatory Authority for assigned protocols
    • Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments; responsible for quality and compliance in assigned protocols in country; contribution to the development of local SOPs; overseeing Clinical Trial Coordinators as applicable
    • Coordinates and liaises with Country Research Manager, Clinical Trial Coordinator, Clinical Research Associate, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, Clinical Trial Research Agreements and local milestones; collaborates closely with Regional Operations to align country timelines for assigned protocols
    • Oversight and coordination of local processes; clinical and ancillary supplies management, im- and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management; enters and updates country information in clinical systems

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