Covance

GSS Specialist II

CH
Job Number
2017-15584
Job Category
Other
Position Type
Full-Time

Job Overview

We are recruiting for a GSS Specialist II to be office based in Lucerne, Switzerland.  This is a fantastic role to join a growing, dynamic team. 

 

Role and responsibilities:-

 

Country submissions & local language materials:

  • 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.
  • Works in partnership with IRB/IEC and Regulatory Authority in submission and approval-related interactions for assigned protocols and to establish reasonable approval timelines

Financial:

  • Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).
  • Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.
  • Oversight and tracking of clinical research-related payments and payment reconciliation at study close-out.
  • Oversight, Denied Parties Screening and maintenance of financial systems.
  • Financial forecasting and tracking of operational budget in conjunction with Clinical Research Director.

Management & quality oversight:

  • Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments and to maintain quality and compliance in assigned protocols in the country.

Collaboration:

  • Works in close collaboration internally with GCTO country operations (CRM, CTC,CRA), CQM, Finance, Medical Affairs, Regulatory Affairs, PV, Business Compliance, Legal and regional operations, HQ and Regional functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.
  • Provides support and oversight to local vendors as applicable.

Local process oversight:

  • Responsible for clinical and ancillary supplies management, importing 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, regulatory, safety and finance systems.

Education / Qualifications

Bachelor's Degree (or comparable) in Business Finance/ Administration/ Life Science or Master Degree in Medical Science

Experience

  • 3-5 years clinical research experience
  • Expertise of core clinical, regulatory and financial systems, tools and metrics.
  • Extensive knowledge of local regulatory environment and submission and approval processes.
  • Skilled knowledge of budget and contract negotiations
  • Knowledge of the local ethics, legislation and regulatory environment,
  • Insight into submission and approval processes
  • Development of local Informed Consent as well as other site ready and ongoing study deliverables.
  • Ability to proactively develop risk management and mitigation plans in the
  • country and resolve issues locally
  • Team player who is able to collaborate within a team of 4 COMs since we are working in the cluster Mid Europe 1 (Austria & Switzerland ) where a harmonized process is required
  • The ability to focus on multiple deliverables and protocols simultaneously is essential and strong coordination and organizational skills a must
  • Strong communication and leadership and negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal
  • Fluency in both German and English plus any other country language (preferred)
  • Office based in Lucerne

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