Início United States Associate Director TMF Operations
Início United States Associate Director TMF Operations
Associate Director TMF Operations
Detalhes do emprego
CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives. With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. Could you be our next Associate Director, TMP Operations? This position is located in our King of Prussia PA or Marburg Germany office. It is a Hybrid role. You will report to the Director of Risk Management and Assessment.
The Opportunity
You will provide guidance to a dynamic team and is accountable to ensure consistency of operations and delivery of TMF operations and support services across all Therapeutic Areas. You will have oversight in different aspects of TMF operations including TMF support, execution improvement, inspection readiness, compliance and management. You will support all Therapeutic Areas and multiple Clinical Development Operations responsibilities and interfaces with the senior leaders in the organization. You will ensure that the TMF Operations standards, processes and KPIs are met. This includes: process development and improvements, resourcing and management of TMF personnel, and interactions with partners and customers. The Associate Director will have oversight for the vendors supporting the TMF; manage the relationship and governance with TMF Vendors. You will be accountable for internal process audits and provide support for both internal study audits and external inspections.The Role
- Global oversight of the TMF, including leadership that the study teams and TMF Operations team are maintaining inspection ready files across programs and regions to improve performance, quality, risk mitigation and contingency planning for TMF Operations.
- Develop and embed process excellence and consistency across TMF Operations. Partner with Therapeutic Area Leads and Study Execution Team Leads to ensure fulfillment of the operational TMF needs of the clinical programs.
- Establish industry standard technology and processes for TMF: Incorporation of changes to the TMF reference model eTMF system using latest industry features as applicable to CSL’s strategy and process Use industry best practices, using building technology and concepts/methodology.
- You will establish KPIs and metrics for documents in the eTMF and the TMF Operations team, including inspection readiness and oversight of preferred providers.
- Provide oversight of Functional Service Providers for TMF related activities to
- Provide TMF support for both inspection and audit activities for internal and external hosted audits. This includes working directly with Agency Inspectors (FDA, PMDA, EMA, MHRA) or auditors; assist with retrieving documents, speaking to the TMF process and assisting with resolving potential issues identified.
Your experience
- Bachelor's degree in life science, pharmacy, or other health/medical related area
- 8+ years’ relevant clinical research (or related) experience in the pharmaceutical industry
- Understanding of the clinical research and drug development lifecycle
- Knowledge of ICH GCP, FDA GCP Regulations and EU Clinical Trials Regulations
- Management experience with groups in clinical operations. Benefits
- Medical, Dental, Vision
- 401K
- PTO #LI-Hybrid
Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what’s available to you as a CSL employee.About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring .We want CSL to reflect the world around us
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.Do work that matters at CSL Behring!
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Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives. </p><p></p><p> With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. </p><p></p><p> Could you be our next Associate Director, TMP Operations? This position is located in our King of Prussia PA or Marburg Germany office. It is a Hybrid role. 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Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives. </p><p></p><p> With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. </p><p></p><p> Could you be our next Associate Director, TMP Operations? This position is located in our King of Prussia PA or Marburg Germany office. It is a Hybrid role. You will report to the Director of Risk Management and Assessment. </p><p></p><h2><b> The Opportunity </b></h2><p> You will provide guidance to a dynamic team and is accountable to ensure consistency of operations and delivery of TMF operations and support services across all Therapeutic Areas. You will have oversight in different aspects of TMF operations including TMF support, execution improvement, inspection readiness, compliance and management. You will support all Therapeutic Areas and multiple Clinical Development Operations responsibilities and interfaces with the senior leaders in the organization. </p><p></p><p> You will ensure that the TMF Operations standards, processes and KPIs are met. This includes: process development and improvements, resourcing and management of TMF personnel, and interactions with partners and customers. The Associate Director will have oversight for the vendors supporting the TMF; manage the relationship and governance with TMF Vendors. You will be accountable for internal process audits and provide support for both internal study audits and external inspections. </p><p></p><h2><b> The Role </b></h2><ul><li><p> Global oversight of the TMF, including leadership that the study teams and TMF Operations team are maintaining inspection ready files across programs and regions to improve performance, quality, risk mitigation and contingency planning for TMF Operations. </p></li><li><p> Develop and embed process excellence and consistency across TMF Operations. Partner with Therapeutic Area Leads and Study Execution Team Leads to ensure fulfillment of the operational TMF needs of the clinical programs. </p></li><li><p> Establish industry standard technology and processes for TMF: </p><p> Incorporation of changes to the TMF reference model </p><p> eTMF system using latest industry features as applicable to CSL’s strategy and process </p><p> Use industry best practices, using building technology and concepts/methodology. </p></li><li><p> You will establish KPIs and metrics for documents in the eTMF and the TMF Operations team, including inspection readiness and oversight of preferred providers. </p></li><li><p> Provide oversight of Functional Service Providers for TMF related activities to </p></li><li><p> Provide TMF support for both inspection and audit activities for internal and external hosted audits. This includes working directly with Agency Inspectors (FDA, PMDA, EMA, MHRA) or auditors; assist with retrieving documents, speaking to the TMF process and assisting with resolving potential issues identified. </p></li></ul><p><h2><b> Your experience </b></h2><ul><li><p> Bachelor's degree in life science, pharmacy, or other health/medical related area </p></li><li><p>8+ years’ relevant clinical research (or related) experience in the pharmaceutical industry </p></li><li><p> Understanding of the clinical research and drug development lifecycle </p></li><li><p> Knowledge of ICH GCP, FDA GCP Regulations and EU Clinical Trials Regulations </p></li><li><p> Management experience with groups in clinical operations. </p><p></p><p><b> Benefits </b></p></li><li><p> Medical, Dental, Vision </p></li><li><p>401K </p></li><li><p> PTO </p><p></p><p>#LI-Hybrid </p><p></p></li></ul><p></p><h2><b> Our Benefits </b></h2><p> CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. </p><p></p><p> Please take the time to review our benefits site to see what’s available to you as a CSL employee. </p><h2><b> About CSL Behring </b></h2><p> CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring . </p><p></p><h2><b> We want CSL to reflect the world around us </b></h2><p> As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. 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Hiring company
CSL Behring
-
AED 112Duração: Upto 2 Hours
-
AED 154
AED 360Duração: 1 To 2 Months
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