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Clinical Operations Enablement Associate
(Clinical Operations Department)
Department: Clinical Operations
Function: Study Management and
Operations Reports To: CS & E Group Manager
Date: Oct 2010
Global Reports To: None
Location: China
Number of Positions: 1
Band: 3(US)/B (EU)
Description:
Actively supports Clinical Operations by ensuring the population and
availability of complete, high quality data from Clinical Operations
processes and systems. Delivers Clinical Operations processes and
systems
training and participates in the coordination of the life cycle
management
of processes and systems/tools including associated documentation (
procedural, system). Delivers global central services across drug
projects
and/or other activities that enable delivery of Clinical Development
programs to time, cost, and quality across all delivery models. The
role
requires the demonstration of professionalism and mutual respect in all
interactions.
Accountabilities/Responsibilities:
• Set-up and maintains systems/tools and data associated with
Clinical Operations enabling services in partnership with Study Teams to
appropriate standards, completeness, quality and consistency
• Participates in the life cycle management (development,
implementation, compliance, maintenance, issue resolution, continuous
improvement, decommissioning) of Clinical Operations processes, systems/
tools, standards, procedural documentation and training materials
• Delivers shared services across drug projects (e.g. document
management support, Investigator Safety Letter Distribution, system
support)
• Supports activities that ensure Clinical Operations compliance
and license to operate (e.g. HCP regulations); Supports activities
associated with audits, regulatory inspections and litigation requests
in
conjunction with study delivery teams, CA&A and other stakeholders
• Provides appropriate support and expertise (process and systems/
tools) to user communities including Alliance Partners and/or AZ
Interface
roles; Receives and loads data from external partners for internal
processing; Ensures the monitoring of the integrity of data in systems
and
learning applied in process improvements
• Supports the development of business cases for prioritization of
Continuous Improvement project proposals
• Conducts relevant process and system/tool trainings; Works with
teams and colleagues across the organization to support consistent ways
of
working and adherence to best practice; Develops and maintains
communication
tools supporting Clinical Operations
• Contributes to the development of User Requirement Specifications
Minimum Requirements – Education and Experience
• University degree or equivalent work experience
• Experience in the pharmaceutical industry working in an
environment of clinical study delivery/clinical development processes
• Knowledge of pharmaceutical drug development and clinical study
processes and associated government regulations, ICH and GCP
Preferred Requirements – Education and Experience
• University degree in biological science or health care related
field
• A good understanding of the clinical study process
• Programming experience or programming aptitude
Skills and Capabilities
• Good organizational and project management skills; Proactively
identifies risks and issues and possible solutions; Demonstrates ability
to
follow tasks through to completion
• Ability to understand how task combine into efficient workflow
• Demonstrates computer proficiency, the ability to develop
advanced computer skills, and the technical aptitude to increase
efficiency
in day-to-day tasks
• Technical skills or knowledge expertise in one or more areas
supported (e.g. Study Management, Data Management, IVRS, Data standards,
etc
.)
• Holds self accountable for achieving objectives, applying best
practice, and adhering to standards
• Proven analytical thinking, concern for standards, and
willingness to learn from others
• Ability to work collaboratively in a team environment as well as
independently
• Demonstrates professionalism and mutual respect
• Good negotiation and conflict resolution skills
• Good written and verbal communication skills in English
Leadership Skills:
• Passion for Customer (Target Level 2)
• Thinks Strategically (Target Level 2)
• Acts Decisively (Target Level 2)
• Drives Performance (Target Level 2)
• Works Collaboratively (Target Level 2)
Internal and External Contacts/Customers (Examples)
• Study Management, Study Team personnel
• Marketing Company personnel
• Study Site personnel
• Monitoring personnel
• Other Clinical Operations/Clinical Development personnel as
appropriate
• External Service Provider personnel
Study Operations Specialist (Operations Department)
Department: Operations
Function: Clinical Development
Reports To: Operations Group Manager
Date: Oct 2010
Global Reports To: None
Location: China
Number of Positions: 1
Banding: 4(US)/C(UK/SE)
Description:
Lead and coordinate activities that ensure quality, consistency,
and
integration of study data and progress operational deliverables to time
cost
and quality objectives from Study Specifications (SS) through study
close-
out activities and Clinical Study Report (CSR). Work with and lead
cross-
functionality, with internal and external partners, on global studies
across
different phases of drug development and different therapy areas.
Accountabilities/Responsibilities:
• Coordinate operational aspects of AZ and Investigator Sponsored
studies from SDC/Proposal through CSR/Publication.
• Lead and/or participate in activities that ensure quality,
consistency and integration of study data to agreed time, cost and
quality
objectives
• Interface with Data Management Center representatives/Data
Management Enablement, to facilitate the delivery of study data
• Establish and maintain interactions with key stakeholders
including the facilitation of communications with MCs, Strategic
Partners,
Academic clinics and investigational study sites, as appropriate, and
external service providers (Third Party Vendors) to identify and resolve
operational feasibility issues, facilitate study start-up activities,
and
ensure Operations deliverables to time, budget and quality objectives
• Implement globally agreed Operations and Clinical Development
strategies including processes and use of technical systems related to
Operations
• Contribute to protocol development and the development of other
Operations documents as appropriate as well as any updates/amendments
to
those documents
• Provide input to data management documents (e.g. Case Report Form
, Data Management Plan)
• Lead the preparation of country specific agreements,
confidentiality agreements, clinical trial applications and in the
development of the Source Data Verification (SDV) plan and other
applicable
Operations documents
• Contribute to review of new/amended/unique project Clinical
Information Standards Governance Organisation (CISGO) Standards
Repository
Components
• Ensure timely entry and/or update appropriate information into
AstraZeneca tracking and communication tools (e.g. IMPACT, ISSIS and
Clinical Partners Portal)
• Ensure the supply of study materials and Investigational product
by liasing with Investigational Product Supply or external service
providers
as appropriate
• Support the study delivery team and Clinical Advice and Assurance
(CA+A) in the development of and implementation of audits and
regulatory
inspections
• Contribute to the planning and conduct of internal and external
meetings (e.g. Investigator/Monitors meetings, Investigator Sponsored
Study
Review and Oversight Team (ISSROT) meetings
• Monitor study conduct and progress, proactively identifying to
and resolving with the SD Leader, issues which may impact delivery of
the
study or to the necessary quality, timeline or budget objectives
• Monitor and support clinical study sites as applicable
• Contributes to steering committees, submission assembly teams,
regulatory defence teams, and Advisory Boards as necessary
• Contribute to ad hoc team productivity and efficiency by
providing direction and facilitating good team dynamics
• Provide input into non-drug project work including training
activities, and development of procedures as needed
Minimum Requirements –Education and Experience
• Bachelor of Science degree in related discipline, preferably in
medical, biological, or health related sciences, or equivalent work
experience in directly related fields
• Experience working on clinical studies, across different phases
of drug development
• Four or more years of relevant industry or health care experience
• Proven organizational and analytical skills
• Understanding of the clinical study and drug development process
and GCP/ICH guidelines in relation to Study delivery operational
activities
• Computer proficiency
• Excellent knowledge of spoken and written English
Skills and Capabilities
• Demonstrates ability and willingness to work and lead cross-
functionally, e.g. with internal and external partners, on global
studies,
across different phases of drug development or different therapy areas
• Good understanding of Clinical data flow
• The ability to develop advanced computer skills to increase
efficiency in day to day tasks
• Excellent verbal and written communication and presentation
skills
• Demonstrates ability to work independently, as well as in a team
environment
• Proven ability to prioritize and manage multiple tasks with
conflicting deadlines
• Excellent interpersonal skills and proven ability to facilitate
team building and team work
• Willingness to travel both domestically and internationally
• Demonstrates sound knowledge of GCP, AZ Procedural documents, as
they pertain to Study delivery systems and processes
• Proactively identifies risks and issues and possible solutions
• Demonstrates high standards and uses tactful persuasion to obtain
desired outcomes while maintaining effective, positive, organizational
relationships
• Develops knowledge of therapy area through experience and review
of scientific literature, and demonstrates ability to learn new therapy
areas
• Demonstrates ability to prepare and deliver study related
training materials
• Demonstrates ability to plan, coordinate, and facilitate internal
and external meetings
• Demonstrates professionalism and mutual respect
• Displays excellent organization and time management skills,
excellent attention to detail, and ability to multi-task in a high
volume
environment with shifting priorities
• Demonstrated Project Management skills (e.g. leading delivery
team)
• Excellent mentoring skills and ability to develop others
Organizational Behaviours
• Passion for customers
• Thinks strategically
• Acts decisively
• Drives performance
• Works collaboratively
• Develops people & organisation
Internal and External Contacts/Customers - Some examples of contacts/
customers are:
• Operations personnel
• Data Management Centre
• CPT and therapy area personnel
• Clinical Development personnel
• External service providers and strategic partners
• Study Site personnel
• Marketing Company personnel
• Other R+D Hubs
• Regional Monitoring personnel
• Other Skill Centers as appropriate |
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