Centralized Monitoring Therapy Area Lead
Warszawa Centralized Monitoring Therapy Area Lead
Warszawa
NR REF.: 1103723
About us
AstraZeneca is one of the world’s most exciting bio-pharmaceutical companies. From scientists to sales, lab techs to legal, we’re on a mission to turn ideas into life-changing medicines that improve patients’ lives and benefit society. We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world.
The role
The Therapy Area Lead (CMTAL) is responsible for providing studies within his/her TA with Centralized Monitoring service in order to enable Risk-Based Monitoring ensure data quality and protect patient’s rights.
The CMTAL will guide the project team, study team and SMM at the initial stages of the studies to define centralized monitoring needs. The CM service will be executed by a group of CM analysts guided by CMTAL. In order to effectively execute the tasks the CMTAL will have a very good understanding of internal and external challenges in data quality including results of regulatory submissions in the Therapy Area. Importantly these accountabilities will be achieved by extensive collaboration and alignment with the Data Management, Biometrics and Information Sciences (B&I), Therapy Areas (TAs), Site Management and Monitoring (SM&M) and other internal and external stakeholders.
This role is located within Operational Enablement/Study Management and Operations/Clinical Operations in Global Medicines Development (GMD) and reports to Associate Director Centralized Monitoring.
Candidate Focus & Challenge
• Ensure studies are provided with centralized monitoring service in order to:
enable risk-based monitoring
secure data quality that will support regulatory submissions and robust investment decisions
support protection of study participants rights
• Maintain high level of understanding of regulatory agencies and other external and internal stakeholders’ requirements in terms of data quality
• Create and maintain TA-specific metrics and risk indicators (M&RI) in the CM M&RI library
• Contribute to the development of CM methodology
• Engage project teams, study steams and SMM in the initial stages of studies in order to develop study specific critical to quality factors, acceptable defect rates and risk management strategies
• Author Risk-based monitoring plans for studies soliciting and incorporating input from project teams, study teams, SMM, DM and B&I
• Lead the team of CM analysts in delivery of Centralized Monitoring services to studies including regular reviews of study data, provision of information to stakeholders, follow up of actions
• Ensure transfer of leanings between studies within the Therapeutic Area
• Ensure assessment of CM services effectiveness in completed or terminated
studies
• Develop, coach, mentor, motivate and inspire individuals within the CM
organization especially in the therapy area of interest
Qualifications
• MSc Degree or equivalent in the life sciences or related discipline
• Scientific background is beneficial
• Excellent knowledge of Risk-Based Monitoring (RBM) methodology and tools,
industry trends, and role and place of CDM within RBM.
• Solid knowledge of basic statistical tools and methods used for centralized
monitoring
• Previous experience from RBM and CDM is advantage
• Excellent knowledge of clinical trial monitoring and Study Team processes
• Comprehensive knowledge of clinical and pharmaceutical Drug Development
Process
• Comprehensive knowledge and understanding of Clinical Operations
technology and standards, Clinical Data Management, Monitoring practices
and regulations, GCP and quality requirements in clinical trials
• Clinical Operations experience within the therapy area of interest
• Ideally has experience in more than one company and/or geographical region
• Solid computer skills are necessary (e.g. advanced excel)
• Programming skills (SAS, R) are an advantage
• Excellent communication and influencing skills
• Ability to interact with Senior Management.
• Strong focus on delivery with high quality
• Demonstrated ability to set and manage priorities, resources, performance
targets and project initiatives in a global environment
• Cultural Awareness: Is aware of and sensitive to cultural differences and their
impact on communication, expectations and performance.
• Experience working internationally: working with major markets/resolution of
international issues
• Teamwork and cross functional Collaboration: Is effective in leading and being
a member of teams, both locally and internationally.
• Business planning skills: has knowledge/experience of planning processes
used in drug projects
• Experience on effective Risk management
• Good spoken and written English
Values & Behaviours
• We follow the science
• We put patients first
• We play to win
• We do the right thing
We offerstable employment conditions, wide benefit package and the opportunity to participate in building a new team .If you would like to apply for the above position, please send your application documents (actual curriculum vitae) in English.
Warszawa
NR REF.: 1103723
About us
AstraZeneca is one of the world’s most exciting bio-pharmaceutical companies. From scientists to sales, lab techs to legal, we’re on a mission to turn ideas into life-changing medicines that improve patients’ lives and benefit society. We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world.
The role
The Therapy Area Lead (CMTAL) is responsible for providing studies within his/her TA with Centralized Monitoring service in order to enable Risk-Based Monitoring ensure data quality and protect patient’s rights.
The CMTAL will guide the project team, study team and SMM at the initial stages of the studies to define centralized monitoring needs. The CM service will be executed by a group of CM analysts guided by CMTAL. In order to effectively execute the tasks the CMTAL will have a very good understanding of internal and external challenges in data quality including results of regulatory submissions in the Therapy Area. Importantly these accountabilities will be achieved by extensive collaboration and alignment with the Data Management, Biometrics and Information Sciences (B&I), Therapy Areas (TAs), Site Management and Monitoring (SM&M) and other internal and external stakeholders.
This role is located within Operational Enablement/Study Management and Operations/Clinical Operations in Global Medicines Development (GMD) and reports to Associate Director Centralized Monitoring.
Candidate Focus & Challenge
• Ensure studies are provided with centralized monitoring service in order to:
enable risk-based monitoring
secure data quality that will support regulatory submissions and robust investment decisions
support protection of study participants rights
• Maintain high level of understanding of regulatory agencies and other external and internal stakeholders’ requirements in terms of data quality
• Create and maintain TA-specific metrics and risk indicators (M&RI) in the CM M&RI library
• Contribute to the development of CM methodology
• Engage project teams, study steams and SMM in the initial stages of studies in order to develop study specific critical to quality factors, acceptable defect rates and risk management strategies
• Author Risk-based monitoring plans for studies soliciting and incorporating input from project teams, study teams, SMM, DM and B&I
• Lead the team of CM analysts in delivery of Centralized Monitoring services to studies including regular reviews of study data, provision of information to stakeholders, follow up of actions
• Ensure transfer of leanings between studies within the Therapeutic Area
• Ensure assessment of CM services effectiveness in completed or terminated
studies
• Develop, coach, mentor, motivate and inspire individuals within the CM
organization especially in the therapy area of interest
Qualifications
• MSc Degree or equivalent in the life sciences or related discipline
• Scientific background is beneficial
• Excellent knowledge of Risk-Based Monitoring (RBM) methodology and tools,
industry trends, and role and place of CDM within RBM.
• Solid knowledge of basic statistical tools and methods used for centralized
monitoring
• Previous experience from RBM and CDM is advantage
• Excellent knowledge of clinical trial monitoring and Study Team processes
• Comprehensive knowledge of clinical and pharmaceutical Drug Development
Process
• Comprehensive knowledge and understanding of Clinical Operations
technology and standards, Clinical Data Management, Monitoring practices
and regulations, GCP and quality requirements in clinical trials
• Clinical Operations experience within the therapy area of interest
• Ideally has experience in more than one company and/or geographical region
• Solid computer skills are necessary (e.g. advanced excel)
• Programming skills (SAS, R) are an advantage
• Excellent communication and influencing skills
• Ability to interact with Senior Management.
• Strong focus on delivery with high quality
• Demonstrated ability to set and manage priorities, resources, performance
targets and project initiatives in a global environment
• Cultural Awareness: Is aware of and sensitive to cultural differences and their
impact on communication, expectations and performance.
• Experience working internationally: working with major markets/resolution of
international issues
• Teamwork and cross functional Collaboration: Is effective in leading and being
a member of teams, both locally and internationally.
• Business planning skills: has knowledge/experience of planning processes
used in drug projects
• Experience on effective Risk management
• Good spoken and written English
Values & Behaviours
• We follow the science
• We put patients first
• We play to win
• We do the right thing
We offerstable employment conditions, wide benefit package and the opportunity to participate in building a new team .If you would like to apply for the above position, please send your application documents (actual curriculum vitae) in English.
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