Site Contract Manager

IQVIA


Date: 3 weeks ago
City: Thāne, Maharashtra
Contract type: Full time
Job Overview

Support the delivery of all required start-up contracting activities for selected sponsors, studies or multi-protocol programs as determined by either the agreed algorithm or the Sponsor’s requirements, including pre-award activities.

Essential Functions

  • Develop simple investigator grant estimates and proposal text to support the proposal development process.
  • Utilize and maintain contract and budget templates and contracting systems, tools, processes, and training materials for selected sponsors, studies or multi-protocol programs according to the Scope of Work and Project Plan, within the agreed project strategy.
  • Ensure collaboration, including communication with sponsors, stakeholders and RSU regions and countries, to successfully deliver the agreed project scope in compliance with sponsor requirements and/or the RSU Management Plan.
  • Provide specialist operational and financial contracting support to facilitate efficient business development and initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
  • Assist in the creation and/or review of core scientific, technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
  • Contribute to the collection, interpretation, analysis and dissemination of accurate contracting intelligence to support assigned studies and the wider company, as required.
  • Ensure overall contracting efficiency and adherence to project timelines and financial goals; report contracting performance metrics and out of scope contracting activities as required.
  • Comply with contract management and quality standards. Provide administrative and operational support to investigator site contract analysts, managers and directors as required.
  • Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans.

Qualifications

  • Bachelor's Degree Bachelor's Degree Req
  • 1 year relevant experience, including demonstrable experience acting as a contract negotiator. Equivalent combination of education, training and experience. Req
  • Good negotiating and communication skills.
  • Good interpersonal skills and a strong team player.
  • Strong technical writing skills.
  • Understanding of regulated clinical trial environment and knowledge of drug development process.
  • Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
  • Knowledge of applicable regulatory requirements, SOPs and company’s Corporate Standards.
  • Good organizational and planning skills.
  • Strong knowledge of Microsoft Office and e-mail applications.
  • Good understanding of clinical trial contract management.
  • Ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
  • Good negotiating and communication skills.
  • Good interpersonal skills and a strong team player.
  • Strong technical writing skills. Understanding of regulated clinical trial environment and knowledge of drug development process.
  • Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
  • Knowledge of applicable regulatory requirements, SOPs and company’s Corporate Standards.
  • Ability to exercise independent judgment.
  • Good organizational and planning skills.
  • Strong knowledge of Microsoft Office and e-mail applications.
  • Ability to interpret pricing models and to prepare proposals, bid grids and budgets.
  • Ability to work well within a matrix team environment.
  • Ability to establish and maintain effective working relationships with co-workers, managers and sponsors.

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