**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 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 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.
**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 .
IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled
IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at ********** to arrange for such an accommodation.
At IQVIA, we have a vision. Where every healthcare decision is based on evidence. Where data science and human science come together to improve global health. Where new and creative solutions aren’t just possible – they are expected.
Thank you for your interest in growing your career with us. It takes insight, curiosity, and intellectual courage to transform healthcare. The 56,000+ employees of the IQVIA family of companies, including Q2 Solutions, are reimagining a world without the consequences of disease. We are brave minds bringing powerful ideas to reality. At IQVIA, you can truly make an impact in an environment where you’re supported to succeed.
