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SSU Manager (SCRA level)

Covance 4/8/2019 3:21:29 PM
JOB ID: 25661 Category: Clinical Research Associates
Munich, Germany

   

 

Job Overview

Covance is searching for Study start up Lead to be client based in Munich.

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


Position Type: Full-Time

Location: Munich, DEU - Germany



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Covance Recruiting Process

Below is a general Overview of Our Recruiting Process

If you’d like to work for us, please submit your resume/CV online. If your ability to use or access our electronic application is limited due to a disability, please visit www.gettinghired.com or call 1-800-978-4473 for help.

We consider applications from everyone who is interested in a position with us and who meets the required criteria and qualifications.

If your application is selected, someone from our recruiting team will contact you to arrange an initial screen. We may carry this out over the phone or at a face-to-face meeting. You must complete the screen to be considered for the position.

Based on the results of the initial screen, we may invite you to an interview. One of our recruiting team members will contact you to arrange this. The process may involve several interviews, initially over the phone, and then face-to-face with different members of the hiring team.

Our interviews follow a behavioral-based format. This means we’ll ask you to give us information that’s specific to your professional and educational experiences.

Hiring team members will share and discuss their input and then make their decision.

If you’re the person who best meets the requirements of the position, a member of the hiring team will get in touch to make you an offer of employment. Covance is an eVerify employer (United States only).