Covance

Study Start Up Manager (Sr CRA level)

Job Location(s) DE
Job Number
2017-16494
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 sciences OR equivalent experience in similar position

Experience

  • Clinical research experience, preferably in the similar position
  • Good oral and written communication skills (German and English)

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed

Tell Us About Yourself

Not ready to apply? Connect with us to join our talent community.