PURPOSE Direct and manage the delivery of all required start-up contracting activities for selected sponsors and for complex studies or multi-protocol programs as determined by either the agreed algorithm or the Sponsor's requirements, including pre-award activities.
RESPONSIBILITIES The role holder may be required to cover all or some of the responsibilities mentioned below but will be expected to focus on certain responsibilities for periods of time.
Responsible for the development of complex investigator grant estimates, contracting strategies and proposal text to support the proposal development process.Develop contract and budget templates and contracting systems, tools, processes, and training materials for selected sponsors and complex 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, operational and financial contracting support to facilitate efficient business development and initiation and maintenance of complex clinical trials, whilst ensuring compliance with regulatory requirements and local laws.Create, publish and/or review core scientific, technical and 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 and provide technical guidance both within and outside the project.Deliver presentations to clients and professional bodies as required.Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans.Take a lead role in developing long standing relationships with preferred Quintiles customers; may serve as a liaison for non-specific projects for top customers.REQUIRED KNOWLEDGE, SKILLS AND ABILITIES Good negotiating and communication skills with ability to challengeGood interpersonal skills and a strong team player; ability to coordinate and collaborate above, across and within complex projectsExcellent legal, financial and/or technical writing skillsThorough understanding of regulated clinical trial environment and knowledge of drug development processKnowledge and ability to apply GCP/ICH and applicable regulatory guidelinesKnowledge of applicable regulatory requirements, SOPs and company's Corporate StandardsProven ability to exercise independent judgment, taking calculated risks when making decisionsStrong leadership skills, with ability to motivate, coach and mentorGood organizational and planning skillsGood presentation skillsStrong knowledge of Microsoft Office and e-mail applicationsStrong knowledge of clinical trial contract managementProven ability to interpret pricing models and to prepare proposals, bid grids and budgetsAbility to work well within a matrix team environmentAbility to establish and maintain effective working relationships with co-workers, managers and sponsors.MINIMUM REQUIRED EDUCATION AND EXPERIENCE Bachelor's degree in a related field andat least2 years' relevant experience, including demonstrable experience acting as a regional or international contract expert; or equivalent combination of education, training and experience.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at https://jobs.iqvia.com
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