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ASSOCIATE LOCAL START UP MANAGER – FSP

Employer
Labcorp
Location
Rome (IT)
Salary
Competitive benefits package
Start date
11 Sep 2019
Closing date
11 Oct 2019

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Job Details

At Covance, you can redefine what is possible and discover your extraordinary potential within our Functional Service Provider team (FSP).

As a Covance employee dedicated to an FSP project you will bring your specialized discipline to a core team working directly with one sponsor.  Currently, we have several job opportunities for Associate Manager, Local Start-up, to work client dedicated with a Top 5 global Pharmaceutical company.

These jobs are office based in Rome.

THE JOB

This position has a significant impact on how Italy can deliver country-specific Start up commitments and objectives. In this job, you will be accountable for the execution and oversight of local operational clinical trial activities in the following areas for your assigned protocols:

FINANCIAL:

  • Ownership of country and site budgets.
  • Development, negotiation and completion of Clinical Trial Research Agreements and clinical and financial contracts within fair market value.
  • Oversight and tracking of clinical research-related payments.
  • Payment reconciliation at study close-out.

 

 

COUNTRY SUBMISSIONS AND LOCAL LANGUAGE MATERIALS:

  • Responsible for execution and oversight of clinical trial country submissions and approvals.
  • Development of local language materials including local language Informed Consents and translations.

MANAGEMENT AND QUALITY OVERSIGHT:

  • Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments.
  • Responsible for quality and compliance in your protocols, contributing to the development of local SOPs.

LOCAL PROCESS OVERSIGHT:

  • Oversight and coordination of local processes.
  • Problem solving and Process Improvement is essential to this position (i.e., issues with budget - CTRA negotiations, Quality and Compliance, Regulatory and legal issues or related to functional area deliverables that could jeopardize protocol milestones.)

WHAT MAKES THIS JOB SPECIAL

  • Career progression will be exceptional because there are lots of studies coming through in 2019
  • As a customer-facing role, this job will build business relationships and represent Client with investigators, functional outsourcing partners and other external partners and therefore have a significant impact on country-level customer relationships.
  • You will find a rich and collaboratively working environment, interacting with country operations (CRM,CTC,CRA), CQM, Finance, Medical Affairs, Regulatory Affairs, but also IRB-IECs and Regulatory Authorities to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones

Our employees make a difference in the lives of millions of people… and you will too.

Join us and see why Covance have been named for the second consecutive year to FORTUNE´s 2019 List of `World´s Most Admired Companies´ and more than 90% of the top 20 global pharmaceutical companies are repeat customers. We can offer you not only a job, but a stable, long-term international career.

OTHER INFORMATION

This role is a full time & permanent position to be employed through Covance.

For more information please contact Carlos Villanueva on (0034) 648 853 615  

EDUCATION

University degree, life science.

Extensive knowledge of:

  • Drug development process and client needs.
  • ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.

EXPERIENCE

This is a high profile job for Covance, this is why we can only consider candidates with:

  • Significant clinical research experience in a sponsor-CRO: 4-6 years of clinical research experience within the Study Start-Up area looking after Submissions to the LA and EC, protocol amendments, contracts and contract negotiation.
  • Budget management.

Company

At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions —because we know that knowledge has the potential to make life better for all. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Here, you can join our more than 70,000 employees, serving clients in more than 100 countries, as we work together to make a real impact on people’s lives. Join us in our pursuit of answers.

 

 

 

 

Company info
Website
Location
Maidenhead Office Park
Westacott Way
Littlewick Green
Maidenhead
SL6 3QH
United Kingdom

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