2 jobs found in basel stadt

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    • basel, basel-stadt
    • contract
    For our client, a pharmaceutical company in Basel we are looking for aClinical Trial LeaderStart date: asapEnd date: 31.12.2022Extension: possibleWork location: BaselWorkload: 100%Responsible for the management and clinical execution of assigned clinical trials within Translational Medicine (TM). Functions as the CTL on the planning and implementation of all operational aspects of assigned TM clinical trials from study concept to reporting according to timelines, budget, operational and quality standards (ICH/GCP/Novartis SOPs and procedures).Tasks & Responsibilities:Function as Clinical Trial Leader for assigned studies (scientific and/or operational complexity) including multi-country / multi-center trials. The main focus will be de- pendent on department workload and need).Responsible for leading and matrix managing the multidisciplinary CTT and support functions to ensure all trial deliverables are met according to timelines, budget, quality standards and operational best practicesAuthor of the clinical study protocol and other study essential documents.Responsible for ordering and management of clinical trial materials, including drug supplies and CRFs.In collaboration with outsourcing/planning/feasibility personnel, CTT, Local CPO representatives and CRAs, identify sites and manage study set-up, including responsibility for organizing and chairing the Investigator meeting(s) (as appropriate), and/or Site Initiation meeting(s).Train and support the CRA(s)/CRO(s) on study protocol and related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects’ eligibility.Ensure the set up and maintenance of the Trial Master File for assigned studies, ensuring all relevant study documents are filed and archived at the end of the study according to the appropriate guidelines.Interact with Investigator sites and CRAs/CROs/vendors to ensure smooth study set up and excellence of study conduct, reviewing site performance, protocol deviations, and maintaining awareness of issues raised.Assist in data review and interactions with the Data Manager, Statistician, and third parties (e.g. outsourced data management or data vendors) to ensure high-quality data are transferred/available in a timely manner.Responsible for report writing of assigned studies either directly contributing to and managing the report writing or liaising with the medical writing/narrative group to ensure the report is completed according to current requirement. Responsible for report publication.In collaboration with the Medical Expert and CTT, coordinate the ongoing medical/scientific review of the clinical trial data (as needed), and coordinate the data analysis and interpretation including the development of first interpretable results, the clinical study report, publications and internal/external presentations. May support the Medical Expert on project documentation e.g. Briefing books, IBs, Annual Safety Reports, responses to Health Authority questions, etc.Ensure a complete review is conducted of all study documentation within the assigned studies/project at the end of each study, with all essential documents appropriately archived and paper Trial Master Files physically transferred to the central archive.Responsible for the coordination of pre-audit activities for nominated projects ensuring a satisfactory outcome is achieved, and address corrective actions.Oversee the work of assigned support CTL(s), ensuring clear delegation/assignment of duties are documented.Contribute to the identification and evaluation of new clinical sites as appropriate for assigned studies.Provide CS&I expert advice to other departments and line functions (e.g. CQA, Drug Metabolism and Pharmacokinetics (DMPK), Drug Supply Management (DSM) as applicable to assigned studies.Must-haves:BSc or MSc in life sciences or nursing; a Ph.D. level scientist with life sciences background; PharmD or equivalent qualification or work experience.Relevant experience (5+ years) in clinical trial management (e.g. study management in a multi-national environment using different models for trial execution).Demonstrated leadership and problem-solving skills.Track record of managing multiple, complex clinical trials.Capable of clear written and verbal expression of ideas, an active/proactive communicator.Ability to interact with a wide range of people and build strong positive relationships.Potential for customer orientation awareness and focus.Excellent organizational skills and interpersonal skills.Ability to work independently and in a team environment managing multiple priorities.
    For our client, a pharmaceutical company in Basel we are looking for aClinical Trial LeaderStart date: asapEnd date: 31.12.2022Extension: possibleWork location: BaselWorkload: 100%Responsible for the management and clinical execution of assigned clinical trials within Translational Medicine (TM). Functions as the CTL on the planning and implementation of all operational aspects of assigned TM clinical trials from study concept to reporting according to timelines, budget, operational and quality standards (ICH/GCP/Novartis SOPs and procedures).Tasks & Responsibilities:Function as Clinical Trial Leader for assigned studies (scientific and/or operational complexity) including multi-country / multi-center trials. The main focus will be de- pendent on department workload and need).Responsible for leading and matrix managing the multidisciplinary CTT and support functions to ensure all trial deliverables are met according to timelines, budget, quality standards and operational best practicesAuthor of the clinical study protocol and other study essential documents.Responsible for ordering and management of clinical trial materials, including drug supplies and CRFs.In collaboration with outsourcing/planning/feasibility personnel, CTT, Local CPO representatives and CRAs, identify sites and manage study set-up, including responsibility for organizing and chairing the Investigator meeting(s) (as appropriate), and/or Site Initiation meeting(s).Train and support the CRA(s)/CRO(s) on study protocol and related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects’ eligibility.Ensure the set up and maintenance of the Trial Master File for assigned studies, ensuring all relevant study documents are filed and archived at the end of the study according to the appropriate guidelines.Interact with Investigator sites and CRAs/CROs/vendors to ensure smooth study set up and excellence of study conduct, reviewing site performance, protocol deviations, and maintaining awareness of issues raised.Assist in data review and interactions with the Data Manager, Statistician, and third parties (e.g. outsourced data management or data vendors) to ensure high-quality data are transferred/available in a timely manner.Responsible for report writing of assigned studies either directly contributing to and managing the report writing or liaising with the medical writing/narrative group to ensure the report is completed according to current requirement. Responsible for report publication.In collaboration with the Medical Expert and CTT, coordinate the ongoing medical/scientific review of the clinical trial data (as needed), and coordinate the data analysis and interpretation including the development of first interpretable results, the clinical study report, publications and internal/external presentations. May support the Medical Expert on project documentation e.g. Briefing books, IBs, Annual Safety Reports, responses to Health Authority questions, etc.Ensure a complete review is conducted of all study documentation within the assigned studies/project at the end of each study, with all essential documents appropriately archived and paper Trial Master Files physically transferred to the central archive.Responsible for the coordination of pre-audit activities for nominated projects ensuring a satisfactory outcome is achieved, and address corrective actions.Oversee the work of assigned support CTL(s), ensuring clear delegation/assignment of duties are documented.Contribute to the identification and evaluation of new clinical sites as appropriate for assigned studies.Provide CS&I expert advice to other departments and line functions (e.g. CQA, Drug Metabolism and Pharmacokinetics (DMPK), Drug Supply Management (DSM) as applicable to assigned studies.Must-haves:BSc or MSc in life sciences or nursing; a Ph.D. level scientist with life sciences background; PharmD or equivalent qualification or work experience.Relevant experience (5+ years) in clinical trial management (e.g. study management in a multi-national environment using different models for trial execution).Demonstrated leadership and problem-solving skills.Track record of managing multiple, complex clinical trials.Capable of clear written and verbal expression of ideas, an active/proactive communicator.Ability to interact with a wide range of people and build strong positive relationships.Potential for customer orientation awareness and focus.Excellent organizational skills and interpersonal skills.Ability to work independently and in a team environment managing multiple priorities.
    • basel, basel-stadt
    • contract
    For our client, a biotechnology company in the Baar area we are looking for aSr Manager, Medical Research OperationsStart date: asapContract: until Dec 2021 with the possibility of extensionTasks & Responsibilities:Drive the overall study management strategy for a specific program.  Provide operational leadership for the program in close collaboration with other leaders and stakeholdersTake responsibility for proposal submissions, budgeting, contracting, study management team formation, and study milestonesCommunicate with Medical Directors, Medical Research Experts, Medical Science Liaisons, medical managers and external investigators on assessment of scientific relevance and feasibility, and provide feedback for proposal improvementDevelop external partnerships in collaboration with Medical Directors and scientific expertsTake ownership of vendor service procurement and vendor oversightLiaise with global departments to ensure all current active studies are appropriately tracked and documented in the Medical Affairs Research SystemCoordinate with internal Biogen process, infrastructure, and compliance colleagues to ensure appropriate SOPs related to data generation, analysis, and dissemination are followed Must haves:Bachelor's degree in a relevant discipline required.  Master's degree preferred.Minimum of 10 years of clinical research experience with CRO/Sponsor Project Management responsibility.Strong Project Management skills including risk assessment and contingency planningDemonstrated ability to influence and manage teamsHigh degree of learning agilityCombination of critical thinking and operational know-howDemonstrated success in working independentlyHigh level of customer orientation awareness and focusStrong preference for experience with late phase and observational clinical researchMS disease research experience preferredExceptional analytical, problem-solving, and troubleshooting abilities.Strong written and verbal communication skills.Fluency in English requireCandidates based in Switzerland or those with a valid Swiss work permit are preferred.
    For our client, a biotechnology company in the Baar area we are looking for aSr Manager, Medical Research OperationsStart date: asapContract: until Dec 2021 with the possibility of extensionTasks & Responsibilities:Drive the overall study management strategy for a specific program.  Provide operational leadership for the program in close collaboration with other leaders and stakeholdersTake responsibility for proposal submissions, budgeting, contracting, study management team formation, and study milestonesCommunicate with Medical Directors, Medical Research Experts, Medical Science Liaisons, medical managers and external investigators on assessment of scientific relevance and feasibility, and provide feedback for proposal improvementDevelop external partnerships in collaboration with Medical Directors and scientific expertsTake ownership of vendor service procurement and vendor oversightLiaise with global departments to ensure all current active studies are appropriately tracked and documented in the Medical Affairs Research SystemCoordinate with internal Biogen process, infrastructure, and compliance colleagues to ensure appropriate SOPs related to data generation, analysis, and dissemination are followed Must haves:Bachelor's degree in a relevant discipline required.  Master's degree preferred.Minimum of 10 years of clinical research experience with CRO/Sponsor Project Management responsibility.Strong Project Management skills including risk assessment and contingency planningDemonstrated ability to influence and manage teamsHigh degree of learning agilityCombination of critical thinking and operational know-howDemonstrated success in working independentlyHigh level of customer orientation awareness and focusStrong preference for experience with late phase and observational clinical researchMS disease research experience preferredExceptional analytical, problem-solving, and troubleshooting abilities.Strong written and verbal communication skills.Fluency in English requireCandidates based in Switzerland or those with a valid Swiss work permit are preferred.

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