Summarized purpose: completes site activation or amendment deliverables within the assigned projects and ensures all project deliverables meet customer expectations, as well as, contracted deliverables by providing accurate projections, report updates, and ongoing risk assessments. essential functions: • collaborates with multiple team members in a matrix environment for the effective delivery of site activation or amendments within assigned projects. • assists with coordination of the flow of information between internal teams, clients, or functional departments involved in site activation or amendments. • participates in developing plans/guidelines for project implementation. • monitors and analyzes project status to ensure successful progress and completion of all assigned projects and provides metrics and status updates to senior team members and/or upper management. • performs risk identification and contingency planning. • collaborates with team members to manage financial and contractual aspects of the studies related to site activation or amendments. • participates in establishing appropriate controls to ensure that project resources and expenses are aligned with budgets. education and experience: bachelor's degree or equivalent and relevant formal academic / vocational qualification previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years’). in some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be conside...
Calling all experienced clinical leads. the clinical lead provides leadership of the clinical team, in support of the project leader, and in collaboration with the other functional teams, to achieve the delivery of the project’s overall objectives to the sponsor’s satisfaction per contract while optimizing speed, quality and cost of delivery and in accordance with our sops, policies and practices. tasks & responsibilities: participate in bid defense preparations. attend bid defense presentations and lead the clinical delivery strategy for medium size and multiple country/region studies, in partnership with business development and senior project leader as needed. develop and maintain clinical project plans, including but not limited to clinical operations plan, recruitment, and retention strategy plan, etc. to be incorporated into the integrated study management plan/project management plan. accountable for the clinical delivery (subject recruitment, site management, data integrity) per contract, ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures. partner with the project leaders to confirm objectives of the clinical team according to agreed-upon contract, strategy and approach. effectively communicate and assess performance against these agreed objectives. ensure all appropriate subject/patient recruitment strategies are in place at the outset of the study to maximize subject/patient recruitment opportunities to achieve delivery according to contract, including, but not limited to, all outreach or d...
Job overview provides leadership of the centralized monitoring team, in partnership with project and clinical lead, and in collaboration with other functional teams, to achieve the delivery of the project’s overall objectives to the sponsor’s satisfaction per contract while optimizing speed, quality and cost of delivery and in accordance with our standard operating procedures, policies and practices. the cml has particular focus on leading/advising the centralized team (centralized monitors and centralized monitoring assistants) towards solutions to clinical risks identified and facilitating successful implementation of those strategies to address the issues. facilitate efficient and effective review of site visit reports and assure consistent standards of implementation for quality to meet or exceed quality standards. ensure subject safety, data integrity, escalation of issues and timely and responsive feedback in compliance with iqvia standard operating procedures, international conference on harmonisation - good clinical practice (ich gcp) guidelines, protocol requirements and regulatory compliance. to provide expertise support in the centralized monitoring studies from applications, analytics and therapeutics or quality perspective. key responsibilities project oversight : oversee clinical deliverables on assigned projects, manage project resources, and coordinate efforts of cross-functional project teams. quality assurance : ensure subject safety, data integrity, and compliance with relevant regulations and guidelines. conduct regular quality checks and manage audi...
At thermo fisher scientific, you’ll discover meaningful work that makes a positive impact on a global scale. join our colleagues in bringing our mission to life - enabling our customers to make the world healthier, cleaner and safer. we provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. with clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our ppd clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. our global clinical operations colleagues within our ppd clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies. discover impactful work: provides administrative and technical support to the project team. supports audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's sop and department guidance document. provides administrative support for site activation activities. aids the development of the critical path for site activation within assigned projects in support of rapid site a...
At thermo fisher scientific, you’ll discover meaningful work that makes a positive impact on a global scale. join our colleagues in bringing our mission to life - enabling our customers to make the world healthier, cleaner and safer. we provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. with clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our ppd clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. we are currently seeking a senior regulatory affairs specialist to join our global regulatory affairs department – regulatory science team. this is a fantastic opportunity to further develop your regulatory career and expertise in a global clinical trial setting. in this role you will be a pivotal team member with regulatory affairs responsibilities, leading discussions, and coordinating regulatory strategies globally on assigned (phase 1 to 4) clinical trials, studies and projects. you will be part of a global team providing innovative solutions and global regulatory expertise, being client interfacing to provide strategic regulatory intelligence and guidance. you will feel confident providing regulatory advice and carry out projects in the provision of regulatory affairs services whil...
Job overview provides high quality, on-time input to client projects in the health economics and outcomes research field. responsible for engaging local and regional clients to develop custom hta and other heor studies, developing innovative product offerings and leveraging latest innovation in technology and data science to develop value added solutions essential functions • under direct supervision, assists with the review and analysis of client requirements or problems and assists in the development of client solutions. health economic modeling • produce draft storyboards for simple health economic models and provide significant input to their further development • review literature to source the required inputs • produce support materials for completed economic models, e.g. reports and training programs market access strategy • collaborate in research projects and produce reports for projects delivering strategic advice to clients on research agendas, value proposition and market access outcomes research/health services research • under close supervision, performs quantitative or qualitative analyzes to assist in the identification of client issues and the development of client specific solutions. • assists in the design and structure of presentations that are appropriate to the characteristics or needs of the audience. • proactively develops a basic knowledge of consulting methodologies and the life sciences market through the delivery of consulting engagements and participation in formal and informal learning opportunities. • engagement based responsi...
At thermo fisher scientific, you’ll discover meaningful work that makes a positive impact on a global scale. join our colleagues in bringing our mission to life - enabling our customers to make the world healthier, cleaner and safer. we provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. with clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our ppd clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. our global clinical operations colleagues within our ppd clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies. discover impactful work: performs and coordinates all aspects of the clinical monitoring and site management process. conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. manages procedures and guidelines from different sponsors and/or monitoring environments ( fso, fsp, government, etc.). acts as a site processes specialist, ensuring that the trial is con...
Sr clinical coder (rave and veeva exp required) updated: march 25, 2025 location: colombia-latin america - col-home-based job id: 25002611 syneos health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. we translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. our clinical development model brings the customer and the patient to the center of everything that we do. we are continuously looking for ways to simplify and streamline our work to not only make syneos health easier to work with, but to make us easier to work for. whether you join us in a functional service provider partnership or a full-service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. we are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. discover what our 29,000 employees, across 110 countries already know: work here matters everywhere why syneos health we are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. we are committed to our total self culture – where you can authentically be yourself. our total self culture is what unites us globally, and we are dedicated to taking care of our people. we are continuously building the company we all want to work for and our customers want to work with. why?...
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)...
Clinical project manager with global/regional experience any ta sponsor dedicated home based argentina, brazil, chile, colombia or peru updated: january 22, 2025 location: colombia-latin america - col-home-based job id: 24006576 clinical project manager with global/regional experience in any ta sponsor dedicated home based argentina, brazil, chile, colombia or peru syneos health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. we translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. our clinical development model brings the customer and the patient to the center of everything that we do. we are continuously looking for ways to simplify and streamline our work to not only make syneos health easier to work with, but to make us easier to work for. whether you join us in a functional service provider partnership or a full-service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. we are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. discover what our 29,000 employees, across 110 countries already know: work here matters everywhere why syneos health we are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. we are committed to our total self culture – where you can authen...
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