Senior/ Investigator Site Contracts Analyst

Purpose:

Coordinate and 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. Provide Legal advice on contracting language. Provide support to other the Regional Investigator Contract Analysts.

Responsibilities:

The role holder may be required to cover all or some of the responsibilities mentioned below but will focus on selected activities at any one time, depending on business requirements:

•Develop contracting strategies and proposal text to support the proposal development process

•Develop contract and budget language 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 legal contracting support to facilitate efficient business development and initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements

•Create and/or review of core administrative documentation to support business development and enable study initiation and maintenance, as required

•Assess and review the contracting landscape and 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

•Work with Quality Management to ensure appropriate contract management and quality standards

•Mentor and coach colleagues as required

•Deliver presentations to clients as required

•Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans

•May take a lead role in developing long standing relationships with preferred customers

•Provide legal advice to colleagues in the Asia Pacific region on Investigator Site Contractual documents

•Provide legal advice to colleagues on country specific legal requirements in the Asia Pacific region

Requirements:

•Bachelor's Degree in law or a related field

•3 to 5 years’ relevant experience, including demonstrable experience acting as a local or regional commercial contracts management specialist

•Good negotiating and communication skills with ability to challenge

•Good interpersonal skills and a strong team player

•Very good legal, financial and/or 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

•Proven ability to exercise independent judgment, taking calculated risks when making decisions

•Good Leadership skills with ability to motivate, coach and mentor

•Good organizational and planning skills

•Good presentation skills

•Strong knowledge of Microsoft Office and e-mail applications

•Good understanding of clinical trial contract management

•Strong legal knowledge

•Strong English language skills both verbal and written

•Ability to work well within a matrix team environment

•Ability to establish and maintain effective working relationships with co-workers, managers and sponsors

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.