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Clinical Scientist
Eingestellt von Michael Bailey Associates - Munich
Gesuchte Skills: Support, Consultant
Projektbeschreibung
CLINICAL SCIENTIST (CS) JOB GRADE:
JOB PURPOSE
The Clinical Scientist is responsible for the scientific strategy of assigned clinical trials for protocol development, ensuring the review/reporting of quality trial data, and study reporting/publishing in compliance with Novartis processes, GCP/ICH and regulatory requirements. Supports program level activities as assigned.
MAJOR ACCOUNTABILITIES)
PROGRAM/PROJECT LEVEL RESPONSIBILITIES:
- Support the development of operational plans for clinical deliverables, effectively applying principles of design excellence:
o Contribute to the development and review of Clinical Development Plan (CDP) with focus on operational aspects
o Contribute/support the Operational CDP (O-CDP)
o Create trial concept sheet.
o Support development of Program Operational Plans (eg budget package, project-level allocation, program-level outsourcing strategy, monitoring committees, etc ).
- Responsible to lead operational excellence in the CSU and scientifically supports CSU by ensuring development of program quality standards (eg collation of synopsis/protocols/CDP reviews, provide scientific/medical input, advisory boards, education activities). Support development and implementation of disease/program standards within CSU.
- Support Medical Lead with the development of program level documents, including clinical sections of regulatory documents (eg Investigators' Brochures, briefing books, submission dossier, and responses to Health Authorities questions).
- Responsible for execution of assigned clinical deliverables within approved budget.
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:
o Seek external (eg KoL, regulatory authorities, patients associations) and internal (eg CSU, 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
- 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 (eg CRFs, protocol deviations, questionnaires, diaries, translations, edit checks)
- As agreed with Medical Lead, manage all trial related committees (eg., 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 database lock; and perform data reconciliation.
- Collaborate with Medical Lead/BSL to identify any safety trends; and as needed, reports on trial data to safety and clinical boards (eg SMT, GCT, GPT).
Frank Arnold
Pharmaceutical Recruitment Consultant
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
JOB PURPOSE
The Clinical Scientist is responsible for the scientific strategy of assigned clinical trials for protocol development, ensuring the review/reporting of quality trial data, and study reporting/publishing in compliance with Novartis processes, GCP/ICH and regulatory requirements. Supports program level activities as assigned.
MAJOR ACCOUNTABILITIES)
PROGRAM/PROJECT LEVEL RESPONSIBILITIES:
- Support the development of operational plans for clinical deliverables, effectively applying principles of design excellence:
o Contribute to the development and review of Clinical Development Plan (CDP) with focus on operational aspects
o Contribute/support the Operational CDP (O-CDP)
o Create trial concept sheet.
o Support development of Program Operational Plans (eg budget package, project-level allocation, program-level outsourcing strategy, monitoring committees, etc ).
- Responsible to lead operational excellence in the CSU and scientifically supports CSU by ensuring development of program quality standards (eg collation of synopsis/protocols/CDP reviews, provide scientific/medical input, advisory boards, education activities). Support development and implementation of disease/program standards within CSU.
- Support Medical Lead with the development of program level documents, including clinical sections of regulatory documents (eg Investigators' Brochures, briefing books, submission dossier, and responses to Health Authorities questions).
- Responsible for execution of assigned clinical deliverables within approved budget.
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:
o Seek external (eg KoL, regulatory authorities, patients associations) and internal (eg CSU, 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
- 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 (eg CRFs, protocol deviations, questionnaires, diaries, translations, edit checks)
- As agreed with Medical Lead, manage all trial related committees (eg., 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 database lock; and perform data reconciliation.
- Collaborate with Medical Lead/BSL to identify any safety trends; and as needed, reports on trial data to safety and clinical boards (eg SMT, GCT, GPT).
Frank Arnold
Pharmaceutical Recruitment Consultant
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Organisation/Management, Sonstiges