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Senior Associate, Clinical Trials (2 year Maximum Duration Contract) J
Eingestellt von Celgene
Gesuchte Skills: Ip
Projektbeschreibung
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Summary/Scope:
The Clinical Trial Associate (CTA) in collaboration with the Study Manager, contributes to the operational execution of clinical studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/WPs. Responsibilities may include participation on one or more cross-functional study team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO) teams and vendors.
Responsibilities involve a combination of execution and oversight, dependent upon the sourcing model, to ensure study deliverables are met and may include, but are not limited to, the following:
Provide operational input on development, management and maintenance of study deliverables [ie timelines, study plans, documents, etc.) through collaboration with internal and external stakeholders
Use performance metrics and quality indicators to assist the study manager in driving study execution
Lead/Participate in monitoring visit report review process in order to maintain oversight of clinical monitoring quality and adherence to protocol and established processes and plans
Manage TMF set-up, ongoing quality review, and final reconciliation
Actively contribute to study meetings including presentation, subject matter expert, generate, finalize and distribute study team agendas and meeting minutesReconcile IP at study level in collaboration with internal and external stakeholders
Ensure full compliance (completenessthis position may suit a CRA with at least 2 years of experience looking to move to an office based position in Clinical Operations.
Strong oral and written skills with proficiency in English
Knowledge of ICH/GCP and regulatory guidelines/directives
Demonstrates analytical approach and anticipation of problems
Identifies gaps and provides constructive feedback and solutions
Ability to multi-task effectively and prioritize assignments from multiple sources
Basic knowledge of clinical research budgets including processing and tracking of site and vendor payments
Basic understanding of project management desired
Excellent organizational skills
Strong knowledge of MS Applications including (but not limited to) MS Project, Word, Excel, PowerPoint
Knowledge of study tools including electronic system skills such as CTMS/EDC
Knowledge of drug development process
Key Leadership Competencies:
Proactively shares information, ideas, input, and/or expertise with team members
Demonstrates concern for high quality outcomes
Displays a willingness to challenge the status quo and take risks
Responds flexibly to changing business demands and opportunities, proactively looking for ways to contribute
Accepts challenging assignments and new responsibilities
Develops and maintains effective working relationships and demonstrates cross-cultural sensitivity when working with others
Uses different communication methods appropriately (eg, email, voice mail, face-to-face)
Keeps manager informed of progress and seeks guidance when deadlines or goals are in jeopardy
Promptly communicates information that others need to know in order to do their jobs
REQ ID:
PRIMARY LOCATION: Switzerland--MARIN
JOB:CRA
ORGANIZATION:Celgene R&D Sarl
SCHEDULE:Limited Term
SHIFT:Internship
EMPLOYEE STATUS:Individual Contributor
JOB TYPE:Full-time
JOB LEVEL:Day Job
TRAVEL:Yes, 5 % of the Time
JOB POSTING:2015-03-:00:00.0
Summary/Scope:
The Clinical Trial Associate (CTA) in collaboration with the Study Manager, contributes to the operational execution of clinical studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/WPs. Responsibilities may include participation on one or more cross-functional study team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO) teams and vendors.
Responsibilities involve a combination of execution and oversight, dependent upon the sourcing model, to ensure study deliverables are met and may include, but are not limited to, the following:
Provide operational input on development, management and maintenance of study deliverables [ie timelines, study plans, documents, etc.) through collaboration with internal and external stakeholders
Use performance metrics and quality indicators to assist the study manager in driving study execution
Lead/Participate in monitoring visit report review process in order to maintain oversight of clinical monitoring quality and adherence to protocol and established processes and plans
Manage TMF set-up, ongoing quality review, and final reconciliation
Actively contribute to study meetings including presentation, subject matter expert, generate, finalize and distribute study team agendas and meeting minutesReconcile IP at study level in collaboration with internal and external stakeholders
Ensure full compliance (completenessthis position may suit a CRA with at least 2 years of experience looking to move to an office based position in Clinical Operations.
Strong oral and written skills with proficiency in English
Knowledge of ICH/GCP and regulatory guidelines/directives
Demonstrates analytical approach and anticipation of problems
Identifies gaps and provides constructive feedback and solutions
Ability to multi-task effectively and prioritize assignments from multiple sources
Basic knowledge of clinical research budgets including processing and tracking of site and vendor payments
Basic understanding of project management desired
Excellent organizational skills
Strong knowledge of MS Applications including (but not limited to) MS Project, Word, Excel, PowerPoint
Knowledge of study tools including electronic system skills such as CTMS/EDC
Knowledge of drug development process
Key Leadership Competencies:
Proactively shares information, ideas, input, and/or expertise with team members
Demonstrates concern for high quality outcomes
Displays a willingness to challenge the status quo and take risks
Responds flexibly to changing business demands and opportunities, proactively looking for ways to contribute
Accepts challenging assignments and new responsibilities
Develops and maintains effective working relationships and demonstrates cross-cultural sensitivity when working with others
Uses different communication methods appropriately (eg, email, voice mail, face-to-face)
Keeps manager informed of progress and seeks guidance when deadlines or goals are in jeopardy
Promptly communicates information that others need to know in order to do their jobs
REQ ID:
PRIMARY LOCATION: Switzerland--MARIN
JOB:CRA
ORGANIZATION:Celgene R&D Sarl
SCHEDULE:Limited Term
SHIFT:Internship
EMPLOYEE STATUS:Individual Contributor
JOB TYPE:Full-time
JOB LEVEL:Day Job
TRAVEL:Yes, 5 % of the Time
JOB POSTING:2015-03-:00:00.0
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung