• I

    As a Sr. CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. What you will be doing: Ensuring regulatory, ICH-GCP and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates significant issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. Per the Clinical Monitoring/Study Monitoring Plan (CMP/SMP): Ability to conduct monitoring activities using different methods, e.g., both on-site and remote, where allowed by country regulations. Conducts Source Document Review and Source Data Verification of appropriate site source documents and medical records Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Manages reporting of protocol deviations and appropriate follow-up. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. Manages reporting of identified issues and manages follow-up to resolution. Documents activities via follow-up letters, monitoring reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Study Monitoring Plan. Ensures all activities are managed by site personnel who are appropriately delegated and trained. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets. Review Data entry timeliness in line with outlined requirements, missing pages, outstanding data queries, timelines for database locks. Review site signature sheet and delegation of duties log to confirm any newly added or removed site staff are documented appropriately and the log is up to date. Where the site or Site Signature Sheet and Delegation of Duties Log indicates site personnel are no longer active on a study review and assess training compliance with any new/updated training requirements (i.e., protocol amendment(s), etc.) Conduct Follow-up for Escalated AEM Report Query Check the site/external facilities, equipment and supplies (clinical and non-clinical) continue to be adequate to conduct the trial and with their expiry dates (as applicable) Check site-specific logs are complete and up to date (e.g., Site Visit Log, Screening and Enrollment Log, Signature Sheet and Delegation of Duties Log, Subject Identification Code List, Investigational Product Accountability Log). Will collaborate with primary Site Manager who will act as the primary liaison with site personnel. Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. You are: Training and Education Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience Prior Experience 5+ years experience as a CRA/Clinical Monitor with demonstrated monitoring experience in oncology (virtual or onsite) Technical Competencies Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements Must demonstrate good computer skills and be able to embrace new technologies Excellent communication, presentation and interpersonal skills Demonstrated networking and relationship building skills Ability to manage required regional travel Ability to communicate effectively and appropriately with internal & external stakeholders Ability to adapt to changing technologies and processes Demonstrated experience of utilising systems like Siebel CTMS, eTMF, eISF (Florence) OR can demonstrate skill sets that show they have agility to work with new systems to support monitoring practice Behavioral Competencies Effectively overcoming barriers encountered during the implementation of new processes and systems Identifies and builds effective relationships with investigator site staff and other stakeholders Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization 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: At ICON, inclusion & belonging are fundamental to our culture and values. 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.

  • B

    About Us Brookfield Renewable is one of the core businesses under Brookfield Corporation (“Brookfield”), one of the world’s leading alternative asset managers. Brookfield Renewable is one of the world’s largest owners, operators, and developers of renewable power, with $102 billion of power assets under management. Our portfolio of hydropower, wind, utility-scale solar, distributed generation, and storage assets extends across North America, South America, Europe, India, and China, totaling almost 33,000 megawatts of capacity, and over 7,000 generating facilities globally. Come Join Us At Brookfield Renewable, we attract and retain high-performing individuals who are interested in making an impact, driving meaningful change and being part of a fast-paced and collaborative environment. Join a purpose driven winning team, committed to results, in an inclusive and high-performing culture. Together, we contribute to the success of one of the fastest growing and largest publicly traded, pure play renewable power platforms in the world while supporting decarbonization and greater energy sustainability to facilitate the global transition to a net-zero. About the Role Reporting to the Managing Director of Global Procurement and Development, the Senior Manager, Strategic Procurement is responsible for leading strategic supplier relationships in North America with Brookfield’s largest equipment suppliers and fostering collaboration with Brookfield’s Portfolio Companies to ensure the successful execution of projects. This role is pivotal in managing our strategic relationships and collaborating with our north American portfolio companies to secure strategic supply agreements. The ideal candidate will have a proven track record in the negotiation and implementation of major equipment contracts for utility-scale renewable energy sites both in North America and around the world. Key Responsibilities Supplier Relationship Management: Develop and maintain strong and mutually beneficial relationships with solar and BESS major equipment suppliers to ensure high-quality, cost-effective procurement solutions. Strategic Sourcing: Collaborate with portfolio companies to identify and leverage opportunities for strategic sourcing, ensuring alignment with overall business objectives and drive results. Cross-Functional Collaboration: Work closely within the Global Procurement team, Brookfield’s portfolio companies and Brookfield’s corporate office to ensure alignment with procurement strategies and seamless execution thereof. Procurement Strategy Development: Develop and implement global sourcing strategies, that align with the company’s long-term goal and leverage the organization’s scale. This includes identifying opportunities for innovation, sustainability, and cost reduction within the procurement process. Negotiate Framework Agreements: Identify, develop and implement sourcing strategies for each category of product, and work closely with colleagues in Global Procurement, technical and legal teams to negotiate multi-year framework agreements. Lead RFP’s for Strategic Major Equipment Purchases: Lead the RFP bid process to successful supplier selection, contract negotiation and contract signature, including preparing bid documents, bid evaluations including normalization of all compliant proposals, ensuring appropriate technical components of the contract are appropriately evaluated and addressed in the procurement process, obtaining stakeholder buy-in, etc. Supplier Evaluation: Assess and evaluate supplier performance, ensuring compliance with quality standards, cost parameters, and project timelines. Market Analysis: Stay current with, and develop leading indicators to predict when possible, market requirements, resources, pricing and trends, and prepare internal briefing decks to keep the business apprised of changing trends in the renewable supply chain. Proactively mitigate supply chain risks, and identify and capitalize on new opportunities Sustainability: Work closely with the Sustainability team to further develop, implement and enhance the organization’s strategy on sustainable supply chain Data-driven approach: Develop and maintain KPI’s to track and report key functional metrics to reduce cost and/or improve effectiveness Knowledge and Experience Required 7+ years Procurement experience, with 3+ years of experience in renewable energy utility-scale projects A university degree in Procurement, Supply Chain, Engineering, Business or Project Management Professional designations including but not limited to PMP, P. Eng, or SCMP considered an asset Strong understanding of the commercial and technical needs of procurement contracts in the Renewable Energy business, in particular experience in procurement of solar and/or battery storage equipment. Experience in high voltage equipment procurement would be considered an asset. Extensive knowledge of, and experience with, recognized procurement practices, including performance and risk mitigation mechanisms in procurement contracts Deep working knowledge of the North American renewable energy market and vendor landscape, pricing, terms and trends, preferably in solar or battery storage Demonstrated ability to manage complex procurement projects and drive cost savings and efficiencies The successful candidate will be positive, proactive and self-driven with exceptional stakeholder management skills combined with strong negotiation, communication, and interpersonal skills Understanding of US ITC and PTC tax credits would be considered an asset Note: Offices continue to be central to collaboration and Brookfield’s identity. This position requires the employee to be on-site for 4 to 5 days to perform most effectively. We will reassess the approach on a as needed basis. Working here, you will enjoy: At Brookfield, your goals are a priority. We start with your strengths and ambitions as an employee and strive to create opportunities to tap into your potential. We work to recognize you in meaningful, personalized ways including a competitive salary, bonus structure, a health benefits program, and defined contribution pension plan. Our spaces are open, dynamic, and collaborative, giving you access to different businesses and teams. For your wellbeing, our building is equipped with a modern gym, bike storage, and healthy snacks and drinks. We cultivate a culture where we invest in your growth and development. Diversity & Inclusion Brookfield Renewable embraces and promotes the principles of diversity, equity, and inclusion. We welcome and encourage applications from all qualified candidates, including women, Indigenous peoples and other persons of all races, ethnic origins, religions, abilities, sexual orientations, and gender identities and expressions. We also provide accommodation during all parts of the hiring process, upon request. If contacted to proceed to the recruitment process, please advise us if you require any accommodation.


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