Employment Type Regular
Job Description The Clinical Scientific Associate Director (CSAD) is responsibleprimarily for Study level clinical activities but also for limited program level activities including supporting the GPMD in developing the scientific and operational strategy of assigned clinical trials to support the overall clinical development plan. This includes but is not limited to protocol development and implementation data collection, analysis, review, reporting and publishing in compliance with Novartis processes, adherence to NVS quality standards and GCP/ICH and regulatory guidance. Program/project level responsibilities: • Responsible for developing the scientific and operational plans for trial level clinical deliverables, effectively applying principles of design excellence: o Contribute to the development and review of Clinical Development Plan (CDP) o Support the development of the Operational CDP (O-CDP) o Create trial concept sheet(s), executable synopses and contribute to final protocol o Develop other program level plans that may require Board approval • Develop strong scientific partnership with key investigators in assigned therapy area(s) to optimize scientific quality/innovation of program and/or clinical study design, execution, reporting and publication. Assist Medical Lead with set-up of program and/or trial-related advisory groups. Support Novartis local medical organizations in the conduct of disease area training/regional advisory meetings. • Collaborate with Medical Lead in the development of program level documents, including clinical sections of regulatory documents (e.g. Investigators’ Brochures, briefing books, submission dossier, and responses to Health Authorities questions). Trial level responsibilities: • Lead the clinical trial protocol development process by independently translating the Clinical Development Plan strategy and approved trial concept sheets into efficient, high quality, executable clinical protocols and related documents: Seek external (e.g. KoL, regulatory authorities, patients associations, etc) and internal (e.g. CDU/TA , CPO Medical Advisors) medical/scientific input o Align input with other line functions o Drive science by incorporation of innovative designs o Obtain approval from internal review boards o Ensure trial implementation according to protocol • Provide support for biomarker planning and /or execution • In collaboration with Trial Statistician, develop Reporting and Analysis Planning (RAP) modules in line with program standards. • Responsible to drive development and implementation of relevant data capture tools in collaboration with GTL and IIS as documented in data handling plan or equivalent document (e.g. CRFs, protocol deviations, questionnaires, diaries, translations, edit checks) • As agreed with Medical Lead, manage all trial related committees (e.g.., Data Monitoring, Adjudication) including decision making around key parameters to monitor and report; preparation of charters and data for review; manage committee meetings/reviews timelines; and provide regular updates to Safety Management Team and other clinical boards. • Responsible for the ongoing review of clinical trial data as outlined in the data handling plan or equivalent, supports GTL to prepare data for database lock; and perform data reconciliation. • Collaborate with Medical Lead/BSL to identify safety trends; and as needed, reports on trial data to safety and clinical boards (e.g. SMT, GCT, GPT).
Minimum requirements
Advanced degree in life sciences/healthcare (or clinically relevant degree) is required. Master’s or PharmD . PhD or MD strongly preferred. Fluent English (oral and written) • ≥3-5 years technical and operational experience in planning, executing, reporting and publishing clinical studies in industry or Academia • Medical/scientific expertise appropriate to program • Demonstrates ability to establish strong scientific partnership with key investigators • Strong interpersonal skills • Ability to work under pressure • Excellent negotiation and conflict resolution skills • Resolve issues with minimal supervision and understand when to escalate • Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and clinical development process. • Demonstrates excellent scientific writing skills • Advanced knowledge of the assigned therapy area is desired, with the capability to interpret, discuss and represent trial or program level data. • Demonstrates knowledge and application of statistical analysis methodology and can identify trends and interpret / report data effectively
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Job Description The Clinical Scientific Associate Director (CSAD) is responsibleprimarily for Study level clinical activities but also for limited program level activities including supporting the GPMD in developing the scientific and operational strategy of assigned clinical trials to support the overall clinical development plan. This includes but is not limited to protocol development and implementation data collection, analysis, review, reporting and publishing in compliance with Novartis processes, adherence to NVS quality standards and GCP/ICH and regulatory guidance. Program/project level responsibilities: • Responsible for developing the scientific and operational plans for trial level clinical deliverables, effectively applying principles of design excellence: o Contribute to the development and review of Clinical Development Plan (CDP) o Support the development of the Operational CDP (O-CDP) o Create trial concept sheet(s), executable synopses and contribute to final protocol o Develop other program level plans that may require Board approval • Develop strong scientific partnership with key investigators in assigned therapy area(s) to optimize scientific quality/innovation of program and/or clinical study design, execution, reporting and publication. Assist Medical Lead with set-up of program and/or trial-related advisory groups. Support Novartis local medical organizations in the conduct of disease area training/regional advisory meetings. • Collaborate with Medical Lead in the development of program level documents, including clinical sections of regulatory documents (e.g. Investigators’ Brochures, briefing books, submission dossier, and responses to Health Authorities questions). Trial level responsibilities: • Lead the clinical trial protocol development process by independently translating the Clinical Development Plan strategy and approved trial concept sheets into efficient, high quality, executable clinical protocols and related documents: Seek external (e.g. KoL, regulatory authorities, patients associations, etc) and internal (e.g. CDU/TA , CPO Medical Advisors) medical/scientific input o Align input with other line functions o Drive science by incorporation of innovative designs o Obtain approval from internal review boards o Ensure trial implementation according to protocol • Provide support for biomarker planning and /or execution • In collaboration with Trial Statistician, develop Reporting and Analysis Planning (RAP) modules in line with program standards. • Responsible to drive development and implementation of relevant data capture tools in collaboration with GTL and IIS as documented in data handling plan or equivalent document (e.g. CRFs, protocol deviations, questionnaires, diaries, translations, edit checks) • As agreed with Medical Lead, manage all trial related committees (e.g.., Data Monitoring, Adjudication) including decision making around key parameters to monitor and report; preparation of charters and data for review; manage committee meetings/reviews timelines; and provide regular updates to Safety Management Team and other clinical boards. • Responsible for the ongoing review of clinical trial data as outlined in the data handling plan or equivalent, supports GTL to prepare data for database lock; and perform data reconciliation. • Collaborate with Medical Lead/BSL to identify safety trends; and as needed, reports on trial data to safety and clinical boards (e.g. SMT, GCT, GPT).
Minimum requirements
Advanced degree in life sciences/healthcare (or clinically relevant degree) is required. Master’s or PharmD . PhD or MD strongly preferred. Fluent English (oral and written) • ≥3-5 years technical and operational experience in planning, executing, reporting and publishing clinical studies in industry or Academia • Medical/scientific expertise appropriate to program • Demonstrates ability to establish strong scientific partnership with key investigators • Strong interpersonal skills • Ability to work under pressure • Excellent negotiation and conflict resolution skills • Resolve issues with minimal supervision and understand when to escalate • Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and clinical development process. • Demonstrates excellent scientific writing skills • Advanced knowledge of the assigned therapy area is desired, with the capability to interpret, discuss and represent trial or program level data. • Demonstrates knowledge and application of statistical analysis methodology and can identify trends and interpret / report data effectively
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