Site Contract Manager
IQVIA
Date: 3 hours 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
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.
- 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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