Sr. Site Contracts Associate (m/w/d)

IQVIA Argentina; Frankfurt; Hybrid; EUR 90.000 - 150.000; Vollzeit

Zusammenfassung

IQVIA is seeking a senior contracting specialist to manage contract strategy and support start-up contracting activities for complex studies across sponsors. The role may include line management responsibilities and requires navigating regulatory requirements in a global, matrixed environment.

The successful candidate will develop contracting templates, coordinate with sponsors and RSU regions, and provide expert legal, operational, and financial contracting support to study teams to drive

Qualifikationen

• 7 years’ relevant sponsor or CRO contracting experience, including international exposure.
• Excellent knowledge of GCP/ICH and applicable regulatory guidelines.
• Strong writing, legal, financial and technical documentation skills.

Aufgaben

• Develop complex investigator grant estimates, contracting strategies and proposal text for sponsor submissions.
• Create templates and tools for contracting processes aligned with project plans.
• Collaborate with sponsors, RSU regions and countries to deliver project scope per requirements.
• Provide legal, operational and financial contracting support for site agreements to enable study initiation and maintenance.

Kenntnisse

Negotiation skills

Communication skills

Project leadership

Team collaboration

Ausbildung

Bachelor's degree in related field

Tools

Microsoft Office

Word

Excel

CTMS

Jobbeschreibung

Job Overview

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.

Essential Functions

• Responsible for the development of complex investigator grant estimates, contracting strategies, coordination of investigator grants, as applicable 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, as applicable to the position.
• 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 the study teams, as applicable to site agreements 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 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, and provide technical guidance both within and outside the project.
• Deliver presentations to clients and professional bodies as required.
• As applicable, 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 clients/customers
• may serve as a liaison for non‑specific projects for top clients/customers.

Qualifications

• Bachelor's Degree Related field Req
• 7 years’ relevant sponsor or clincial research organization clincial site contracting experience, including demonstrable experience acting as an international contract expert.
• Equivalent combination of education, training and experience.
• 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 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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.