Senior Contract Manager
CA-Remote
PRA Health Sciences
Req #: 113841
Type: Canada
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Overview: ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development as a Senior Contract Manager Responsibilities: What you will be doing: The Senior Study Contract Manager (SrSCM) play an important role in driving the costings and contracts being responsible for negotiation and budgeting in clinical trials and for developing and managing contracts and annexes with investigators and institutions or external vendors ensuring ethical, fair and compliant practices. * Adapt global templates of agreements to local use in accordance with local requirements and SOPs. * Develop and negotiate clinical site budgets based on Fair Market Value. * Negotiate agreement language and budget with clinical study sites. * Act as point of contact and interface with Legal if necessary to ensure integrity of contracts. * For each agreement maintain the status of agreement, budgets, issues, payments, any amendments for the duration of the study, and communications with internal and external sources. * Ensure final contract documents are consistent with agreements reached at negotiations. * Ensure all agreements are executed in a timely manner contributing to efficient site start-up timelines. * Support internal and external audits activities. * Ensure that all contracts are included in the TMF Upon local decision, additional responsibilities may include*: * Training and mentoring of new members of the local Study Team regarding financial/contractual issues and sharing experiences. * Support preparation and negotiation of a Local Master Service Agreement * Contribute to process improvements, knowledge transfer and best practice sharing Qualifications: You Are: * Bachelor degree required in related discipline, preferably in life science, law, finance or equivalent qualification. * Minimum of 5 years of experience negotiating industry contracts such as Clinical Study Agreements for sites/SMOs * Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. * Comfortable with excel, Microsoft word track changes. * Good knowledge of relevant local regulations. * Basic understanding of the drug development process. * Good understanding of Clinical Study Management including monitoring, study drug handling and data management. * Excellent attention to details. * Good written and verbal communication skills. * Good collaboration and interpersonal skills. * Good negotiation skills. * Post-graduate training in contracts administration or work experience as a paralegal in pharmaceutical or health care industry preferred. * Good analytical and problem-solving skills. * Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. * Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e- enabled environment. What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: * Various annual leave entitlements * A range of health insurance offerings to suit you and your family's needs * Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead * Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being * Life assurance * Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through this form.
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