Responsibilities & Essential Functions
Develop Coordinate the development of investigator grants and estimates, contracting strategies and proposal text to support the proposal development process.
Develop contract language, payment language and budget templates as required as applicable to the position; utilize and maintain 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 as applicable to the position, to successfully deliver the agreed project scope in compliance with sponsor requirements and/or the RSU Management Plan.
Provide specialist legal, operational and financial contracting support to the Study Teams, as applicable to site agreements to facilitate efficient business development and initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
Assist with 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 as applicable to site agreements; 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 including the delivery of training materials as required.
Deliver presentations to clients as required. As applicable, eEnsure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans.
May take a proactive role in developing long standing relationships with preferred IQVIA clients/customers.
Qualifications - Skills and Abilities
Good negotiating and communication skills with ability to challenge.
Good interpersonal skills and a strong team player; ability to coordinate and collaborate above, across and within complex projects.
Excellent legal, financial and/or technical writing skills.
Thorough 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.
Strong project and people 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, Word and Excel applications.
Strong knowledge of clinical trial contract management.
Ability to work well within a matrix team environment.
Ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
Ability to utilise metrics and then communicate these with study team to establish timelines for deliverables.
Provide input into employee performance reviews, as required.
Proven ability to take on a project or new initiative and grow the program to make an impact across departments.
Qualification - Work Experience
5 years’ relevant experience, including at least 2 years acting as a local or regional contract expert and demonstrable experience in an internal role. Equivalent combination of education, training and experience.
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.