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Job Details

Site Contract & Activation Specialist

Company: Docs Global (Continental Europe)
Location: Warsaw, Poland
Reference: SCAS1-WAW
Closing Date: 16 Dec 16
Type: Full Time
Salary (£): Competitive
Benefits: Competitive salary, medical insurance, annual holiday and other benefits.

Job Summary:

DOCS has partnered with a highly prestigious organisation with one of the most robust pipeline within the industry. We have a great job opportunity for a Start-up/Regulatory Specialists with experience in site contract negotiations who are ready to further develop their career and enjoy working for a global organisation in their offices in Warsaw, Poland.

Requirements:

As a Site Contracts & Activation Specialist you will be responsible for obtaining clinical trial authorisations, ethical approvals, execution of contracts (including budgets), and ensure that the sites are ready for enrolment.

Responsibilities include:

Contracts and budget management

  • Develop/Maintain country and site-specific clinical research templates between the sponsor  and external parties in cooperation with legal and compliance functions
  • Partner with regional and global functions on development of country budgets
  • Negotiate contracts with Institutions and investigators partnering with regional and global functions
  • Facilitate contract amendments as and when required.
  • Develop and maintain country legal guidance documents / library and budget negotiation history
  • Serve as a primary contact for sites and investigators in matters relating to contracts
  • Keep internal functions informed about status and progress in contract negotiations
  • Ensure that essential clinical study documentation related to contracts/budgets/ within country of responsibility is managed in compliance with Good Clinical Practices (GCP) and appropriate Quality Standards

Regulatory responsibilities

  • Prepare and manage regulatory submissions in countries of responsibilities via European regulatory processes, where applicable, to support clinical research
  • Drive collection of required regulatory documents for investigative sites and network with external parties as needed.
  • Provide historical site activation data to Clinical Operations teams to enhance site selection discussions ensuring the appropriate sites are participating in the study
  • Coordinate translation process for all required trial documents and oversee the quality of final documents.
  • Prepare the initial country/site study-level ICFs, as well as revisions as a result of protocol amendments, risk profile updates, etc.
  • Contribute to the country specific ICF template review.
  • Drive timelines for both ERB/CA submissions and approvals, of country-level regulatory package
  • Develop and maintain relationships with ERB/CA, where applicable.
  • Identify potential issues and anticipate current trends related to regulatory/ethical issues and create plan to mitigate them.

Clinical Operations responsibilities

  • Maintain the relevant sections of study Trial Master Files (TMF), any internal reporting systems, and ensure they are inspection ready at all times
  • Prepare submission files
  • Support review and approve Regulatory Template and Multi-phrase translation packets for label creation, where applicable
  • Prepare documentation for site close out and ensure the files are complete and ready for archiving.
  • Ensure access to study systems is provided during site activation.
  • Update and track country study-level tasks for site activation
  • Ensure compliance to the country regulatory requirements within internal systems and maintain it up to date
  • Provide support before, during and after audits/inspections

 

What is required

  • Bachelor’s degree or equivalent, in a science or health related field
  • At least 2 years Clinical Research experience
  • Strong knowledge of regulations, legislation and guidelines applicable for the conduct of clinical studies
  • Previous experience  in contracts and budget negotiations
  • Strong interpersonal skills, including capability to engage in professional relationship building an networking
  • ·Be able to verify translations (make good sense in local languages, is clear and readable) and to be able to adapt language readable format for a patient, where applicable

What is offered

We offer: Competitive  salary, medical insurance, annual holiday and other benefits. 

To Apply:

Please contact Dariusz Sternlicht, Recruitment Consultant at DOCS on +48 606 130 397 or email your up-to-date CV to: dariusz.sternlicht@docsglobal.com

Key words: Contract Negotiation, Regulatory, Start-Up, Budget Negotiation, Regulatory Affairs, RA, Pharmaceutical, CRO, Pharma, Contract Research Organisation, Biotech, Medical Device, Health, Biotechnology, Chemistry, Contract, Warsaw, Poland

 

 

Apply for this job: Site Contract & Activation Specialist

Contact Information:

Address:  Head Office
2 Globeside, Globeside Business Park
Marlow
Buckinghamshire
SL7 1HZ
England
Website:  Visit Our Web Site

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