Job overview associate clinical leads are an integral part of clinical trial delivery, working alongside clinical teams to improve patients’ lives by bringing new drugs to the market faster. the associate clinical lead is a member of the core project team responsible for clinical delivery of clinical studies to meet contractual requirements in accordance with standard operating procedures (sops), policies and practices. associate clinical leads partner with project leaders and other functional teams to secure delivery requirements are always met. you will: • ensure clinical delivery of assigned projects in compliance with regulatory requirements (international conference on harmonization (ich)-good clinical practice (gcp), protocol), customer requirements (contract), and internal requirements (policies, standard operating procedures (sops), project plans). • accountable for meeting projects’ recruitment targets and ensuring appropriate recruitment strategies are in place. • contribute to the development of the project risk mitigation plan and manage clinical risks throughout the project’s lifecycle. • ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues. • identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management. what do you need to have? • bachelor's degree bachelor's degree in health care or other scientific discipline required • re...
Project manager/sr project manager, feasibility site activation - homebased - mexico, brazil, colombia, chile and peru 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 role summary: accountable for driving and accelerating the activation of global investigative sites in line with, or ahead of, the study's contractual timelines, within budgeted resources, with quality output, and exceeding sponsor expectations. accountable for the overall coordination, implementation and completion of site activation or maintenance activities for assigned projects of work in line with icon/sponsor sops as appropriate, including regulatory/ethics, site contracts, essential documents, and site activations. interacts with internal teams and stakeholders, as well as sponsor teams and stakeholders as needed. you will be doing: lead studies with highest quality standards to exceed customer expectations. review study and partnership budgets for proposals and sales as needed. drive assigned studies to meet kpis and delight customers and sites act as customer point of contact for assigned studies; resolve study issues and drive exceptional customer delivery represent fsa at audits and inspections participate in business development opportunities to support the growth of the assigned portfolio, function, and/or region/country(ies) travel (approximately 10% depending on country structure and dire...
Principal biostatistician – leading cro – homebased – spain we have recently partnered with an award winning cro, who are looking for an experienced principal statistician (or senior looking to move into principal), to join their successful study delivery team, any area of specialism considered how you will be a success: as a principal biostatistician, you will be accountable for: leading biostatistics and programming activities for a program of studies with moderate complexity and/or high value and impact for the organization. planning, monitoring, organizing, and reviewing activities of biostatisticians and programmers working on the assigned program of studies. ensuring the timely, budget-compliant delivery of individual studies and integrated analyses to the required quality standards. maintaining consistency across studies within the program. providing strategic oversight and direction, with a focus on optimal resource allocation and effective team performance. leveraging your regulatory interaction experience to ensure compliance with regulatory standards and contribute to submissions and responses to regulatory inquiries. desirable experience: providing biostatistical input into the design of clinical programs, including protocol input such as study design, sample size calculations, and patient randomization schemes. contributing to statistical aspects of case report form (crf) design. reviewing project database structures, edit checks, and data management coding conventions. preparing statistical analysis plans (sap), defining derived data, and designing statisti...
Iqvia biotech is hiring for sr. site contracts associate or site contracts associate in colombia, south america with experience negotiating clinical site contracts and budget templates. grant plan a plus. 3-5 years’ experience for senior level and 1-3 years at the site contract associate level: job overview develop the global contracting strategy and support the delivery of all required start-up contracting activities for selected sponsors, studies or multi-protocol programs as determined by the sponsor’s requirements. essential functions • develop coordinate the development of investigator grants and estimates, contracting strategies and proposal text to support the proposal development process. • develop contract language, payment language and budget templates as required as applicable to the position • utilize and maintain contracting systems, tools, processes, and training materials for selected sponsors, 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 as applicable to the position, 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 clinical trials, whilst enabling compliance with regulatory requirements. • assist with the c...
Msl bogota cundinamarca, co - **function**:research & development - **job type**: full-time job id: r00131116 company description abbvie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. we strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our allergan aesthetics portfolio. **job description**: medical science liaisons (msls) are key members of the affiliate medical department. these field-based roles focus on medical and scientific engagement with abbvie stakeholders (including research and healthcare professionals, payers, and providers). the focus of this role is on interacting with and supporting the needs of thought leaders. msls work to communicate information and facilitate dialogue about abbvie’s marketed products, compounds in development and the related disease states, in a strictly scientific, non-promotional manner, and in full compliance with applicable national laws and regulations, guidelines, codes of conduct, abbvie’s policies and procedures and accepted standards of best practice. the msl serves to enhance the scientific credibility of abbvie with established and emerging thought leaders, by supporting scientific dialogue and collaborations in the areas of research, medical and scientific exchange, including facilitation of requests for scientific and medical information. msls also participate in the initiation, ove...
Job description medical science liaisons (msls) are key members of the affiliate medical department. these field-based roles focus on medical and scientific engagement with abbvie stakeholders (including research and healthcare professionals, payers, and providers). the focus of this role is on interacting with and supporting the needs of thought leaders. msls work to communicate information and facilitate dialogue about abbvie’s marketed products, compounds in development and the related disease states, in a strictly scientific, non-promotional manner, and in full compliance with applicable national laws and regulations, guidelines, codes of conduct, abbvie’s policies and procedures and accepted standards of best practice. the msl serves to enhance the scientific credibility of abbvie with established and emerging thought leaders, by supporting scientific dialogue and collaborations in the areas of research, medical and scientific exchange, including facilitation of requests for scientific and medical information. msls also participate in the initiation, oversight and follow-up of clinical studies and medical projects initiated within the medical department, ensuring that activities are carried out in accordance with relevant processes and procedures. 1. represent abbvie medical affairs as subject matter expert in the assigned ta and territory, provide scientific and technical leadership to ensure professional and credible relationships with external experts /hcps of strategic importance to abbvie. 2. serve as a point of contact within the medical affairs team for...
Job overview under broad guidance, performs activities related to the analysis, design, programming, debugging, modification, and maintenance of software enhancements and/or new products. essential functions • under broad guidance, analyzes, designs, programs, debugs, modifies, and maintains software enhancements and/or new products used in local, networked, or internet-related computer programs. • under broad guidance, may interact with users to define system requirements and/or necessary modifications. • prepares feasibility studies to evaluate requirements for new and revised programs. • translates detailed design specifications into computer program instructions, debugs routine programs, prepares system test data and prepares program documentation. • completes documentation and procedures for installation and maintenance. • code may be used in commercial or end-user applications, such as desktop applications, mobile apps, financial management, or hris products. • using current programming language and technologies, writes code, completes programming, and performs testing and debugging of applications. qualifications • bachelor's degree computer science or related discipline req • incumbent possesses and has demonstrated basic knowledge of systems and software development with a minimum of two (2) years of software development experience. req • lead the building of a dedicated, enthusiastic team of software developers and engineers. • collaborate closely with developers and data scientists. • build and own your team’s roadmap, ensuring alignment with stakeholders in ...
Delivery clinical studies requiere para su equipo de trabajo, químico farmacéutico, ingeniero químico, químico, químico industrial con experiencia para desempeñar el cargo de especialista de estudios clínicos. descripciÓn del puesto desarrollo de métodos por hplc. validación de métodos analíticos y bioanaliticos. manejo de reactivos, preparación de muestras. importante: comunicación asertiva trabajo en equipo autogestión, responsable y ordenado. conocimiento en herramientas ofimáticas (excel, word y powerpoint)...
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