Manage the contract strategy and support delivery of all required start-up contracting activities for selected sponsors and for complex studies or multi-protocol programs as determined by the Sponsor’s requirements. May include line management 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 IQVIA customers; may serve as a liaison for non-specific projects for top customers.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
• Experience with contract from CRO or pharma environment is a MUST
· 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
· 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
· Strong 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
· Strong knowledge of clinical trial contract management
· Proven 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.
POSITION IS HOME BASED, located in LATAM.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
-Bachelor's degree in a related field and 7 years’ relevant experience, including demonstrable experience acting as a regional or international contract expert; or 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.