Company description we are the company that cares - for our staff, for our clients, for our partners and for the quality of work we do. a dynamic, global company founded in 1995, we bring together more than 2,200 driven, dedicated and passionate individuals. we work on the frontline of medical science, changing lives, and bringing new medicines to those who need them. **job description**: you will contribute to statistical programming activities related to global clinical trials, work closely with international teams of statisticians, programmers and data managers, program data sets and summaries. **you will**: - develop analysis data sets structure - develop program requirements and specifications - be involved in sas programming of ads and tables, listings and figures - support sas program validations - prepare and review program documentation - produce tfl - communicate with project teams and company departments with regard to statistical programming of clinical research projects **qualifications**: - university degree in applied science, mathematics, statistics or the like - knowledge of sas software (sas base/sas stat/sas graph) and experience of work in sas system - good knowledge of programming logic, sql and macro programming is preferred - proficient in english, spoken and written - experience within clinical trials and/or biostatistics - good analytical skills - excellent communication and interpersonal skills **please submit your cv in english** additional information our mission is to be the best cro in the world as measured by our...
Company description psi is a leading contract research organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. we focus on delivering quality and on-time services across a variety of therapeutic indications. **job description**: join our international team and be the key support to clinical research projects, streamlining communication, maintaining systems and managing documents & information. only cvs in english will be accepted. **you will**: - be the point of contact for investigational sites, vendors, and multi-functional project teams; - be responsible for document management; - update and maintain (automated) tracking systems and schedules; - coordinate various activities within clinical research projects; - organize meetings, prepare agendas and minutes. **qualifications**: - college/university degree or an equivalent combination of education, training & experience; - administrative work experience, preferably in an international setting; - prior experience in clinical research; - full working proficiency in english and spanish; - ability to plan and work in a dynamic team environment; - communication and collaboration skills. additional information advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with the company....
Company description we are the company that cares - for our staff, for our clients, for our partners and for the quality of work we do. a dynamic, global company founded in 1995, we bring together more than 2,500 driven, dedicated and passionate individuals. we work on the frontline of medical science, changing lives, and bringing new medicines to those who need them. **job description**: you will contribute to statistical programming activities related to global clinical trials, work closely with international teams of statisticians, programmers and data managers, program data sets and summaries. **you will**: - develop analysis data sets structure - develop program requirements and specifications - be involved in sas programming of ads and tables, listings and figures - support sas program validations - prepare and review program documentation - produce tfl - communicate with project teams and company departments with regard to statistical programming of clinical research projects **qualifications**: - university and master's degree in applied science, mathematics, statistics or similar - strong knowledge of and experience with sas software - good knowledge of programming logic, sql and macro programming is preferred - full proficiency in english, spoken and written - previous experience working with clinical trials - good analytical skills - excellent communication and interpersonal skills **please submit your cv in english.** additional information make the right call and take your career to a whole new level. join the company that focuses...
Company description we are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. a dynamic, global company founded in 1995, we bring together more than 2,500 driven, dedicated and passionate individuals. we work on the frontline of medical science, changing lives, and bringing new medicines to those who need them. **job description**: **you will**: - lead all biostatistics activities related to clinical trials as responsible project statistician - communicate with project teams, clients and vendors on statistical questions - develop and review statistical sections of protocols, including sample size calculations - develop statistical analysis plans - develop and document analysis database structures (i.e. sas analysis data set structures) - develop sas program requirements and specifications - sas programming and program validation - review and qc of statistical deliverables (tables, listings, figures, etc.) - perform statistical analysis and report results - consult on experimental design, statistical methods and approaches for the purpose of assessing safety and efficacy of drug products - liaise with dm on statistical questions related to data issues, including coordination of data transfers from dm to statistics - participate in bid defense meetings and kick-off meetings - train statisticians and sas programmers - prepare and deliver presentations at investigators' meetings - address audits findings/recommendations, and follow-up on and resolution of audit findings - participate in the deve...
Site management associate i psi cro ag bogota, d.c., capital district, colombia join our international team as a site management associate i, supporting clinical research projects by streamlining communication, maintaining systems, and managing documents and information. responsibilities include: - acting as the main contact between site personnel and cras, assisting with queries and edc completion. - serving as the primary contact for vendors, study supplies, and access management. - ensuring pre-study testing of local site facilities is completed. - assisting monitors with documentation in ctms and tracking site issues and actions. - managing clinical supplies' order, receipt, storage, distribution, return, and reconciliation. - handling regulatory submissions and notifications, staying updated on local regulations. - coordinating audits and inspections. - managing the tmf at site and country levels, including document filing and updates. - organizing and tracking training for site teams on vendor systems. - reviewing study documentation and translation statuses. - ensuring proper safety information flow with investigative sites. qualifications: - degree in life sciences. - experience in administrative roles, preferably internationally. - experience as a cta in cros and in clinical research. - knowledge of local regulations. - proficiency in english and spanish. - skillful in ms office. - ability to work dynamically in a team and communicate effectively. additional information: advance your career in clinical research by coordinating tasks and growing with the com...
**company description** we are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. a dynamic, global company founded in 1995, we bring together more than 2,800 driven, dedicated and passionate individuals. we work on the frontline of medical science, changing lives, and bringing new medicines to those who need them. join our international team and be the key support to clinical research projects, streamlining communication, maintaining systems and managing documents & information. **only cvs in english will be accepted.** **you will be responsible for**: - being the main point of contact between site personnel and cra involved in the project helping on query resolution and edc completion. - serves as the primary sites’ contact point for vendors, study supplies, and - access management. - ensure that pre-study testing (scans, mri/ct qualification questionnaires, test ecgs, etc.) of local site facilities is completed - act as the one who will ensure the order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies. - ensures regulatory and ethics committee submissions and notifications, meaning you will need to be up to date on local regulations and dispositions. - coordinate preparation for and follow-up on site, tmf and systems´ audits and inspections. - manage the tmf on a site and a country level for regularly and file documents. prepare, distribute, and update investigator site files (isf) and isf checklists. - arrange and track initial and on-going proj...
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