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パレクセルでの仕事

パレクセルは、臨床開発の上流から下流までのそれぞれの専門領域で、国内外の多くのお客様に高度なソリューションを提供するプロフェッショナル集団です。 パレクセルは、新しい薬や治療法を、それらを必要としている人々にいち早く届けることを目指し、日々の業務に取り組んでいます。

Site Contract Leader (FSP)

求人ID 83469BR ロケーション ポーランド共和国 仕事内容
Overview:

The Site Contract Leader serves as a legal liaison to process clinical contract requests such as but not limited to, Non-Disclosure Agreements (NDAs), Clinical Trial Agreements (CTAs), Service Agreements, and Ancillary Agreements and supports the management of and negotiate process of site budgets acting as conduit between investigator sites, Clinical Development Operations (CDO) and the Legal group.

Organizational Relationships:
  • Reports to Parexel FSP assigned Line Manager with day-to-day direction from the Client.
  • Liaises with cross functional lines as appropriate.
Primary Duties:
  • Manage Clinical Contract and Nondisclosure Agreement (NDA) process for Global Trials
  • Serve as legal liaison for clinical contract requests such as, NDA’s, CTAs, Service Agreements, and Ancillary Agreements and act as conduit between CDO and the Legal group
  • Process all clinical contract requests and help facilitate early execution through the Contract Management System
  • Perform consistent quality audits of work output and document knowledge base as needed
  • Maintain accurate contract metrics on an ongoing basis.
  • Serve as primary contact for the Client during contract negotiation phase
  • On-going interface with sites and vendors regarding contractual issues during the lifetime of the contract
  • Establish and maintain direct site and vendor contact
  • Negotiate Clinical Site Contracts & Budgets
For Sites Managed by the Client:
  • Manage and own the contract process through its lifecycle from initial template stage to fully negotiated contract
  • Work closely with study teams to develop a budget template tailored for each study
  • Negotiate and manage consistent site budgets that will assist in early site activation
  • Respond to queries related to contracts and budgets
  • Manage the contract escalation process to appropriate individuals, as needed
  • Establish good customer relations with sites starting with the primary point of contact for budgets and contracts
  • For Sites Managed by a Clinical Research Organization (CRO):
  • Review and approve the investigator fee template per country for each study before distribution to sites
  • Be a conduit for the contract request to the Client Legal team from initial contract request through execution for contracts handled by a CRO and track the contract process for each study with a CRO;
  • Serve as escalation point of contact for budget escalations from CRO;
  • Respond to CRO queries to ensure consistency with contract language and budget line items in accordance with Client standards
  • Adhere to Clinical Operations or project specific quality documents (e.g. Standard Operating Process (SOPs), work practices, training guides), as applicable.
  • Participate in the development and testing of tools and procedures
  • Complete training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training
  • Adhere to FSP and Client SOPs and processes

Qualifications

  • Bachelor’s degree in Life Science, Business, Legal or equivalent
  • Experience working in Clinical Site Contract negotiation, proposal development in a biotech or CRO
  • Intermediate Excel and database management skills
  • Knowledge of ICH/GCP in the provision of clinical trials
  • Excellent negotiation skills
  • Highly organized with excellent oral and written communication skills
  • Work both independently and as part of a team
  • Has a track record of exceeding goals successfully
  • Sets objectives to align with broader organizational goals
  • Partners with others to get work done
  • Follows through on commitments
  • Shows personal commitment and takes action to continuously improve
  • Deals constructively with problems that do not have clear solutions or outcomes
  • Maintains a positive attitude despite adversity
  • Acquires data from multiple and diverse sources when solving problems

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