Associate - Case Processing
ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as an Associate, Case Processing on a temporary basis.
Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career!
Main Job Tasks and Responsibilities:
Collects, records and checks for minimal requirements Serious Adverse Event (SAE) arisen during clinical investigations and during clinical trials.
Manages the generation of queries/questions in case of need of further information to complete or to understand the AE/SAE and manages the follow up for ensuring efficient control and information flow.
Performs the AE/SAE reporting to the Sponsor, guaranteeing smooth and efficient information flow.
Prepares the case narratives, CIOMS I Forms, SAE Forms and all other applicable forms in order to perform safety reporting.
Manages the Safety Database.
Can act as first of contact for the Sponsor for safety matter.
Can act as back up of the safety contact for the Sponsor for safety matter.
Can act as first point of escalation for the Sponsor for safety matter.
Performs the reporting of Suspected Unexpected Serious Adverse Reactions (SUSAR), arisen during clinical trials, to Competent Authorities (CAs), Ethics Committees (ECs) and other recipients ensuring compliance with applicable regulations and appropriate handling.
Manages the unblinding information.
Performs the reporting through EudraVigilance via EVWEB, if qualified.
Performs the periodic reporting to CAs, ECs and other recipients of safety documentation, ensuring compliance with applicable regulations and appropriate handling.
Performs the safety reporting of reportable safety issues (SAE) arisen during clinical studies with medical devices to CAs, ECs and other recipients, ensuring compliance with applicable regulations and appropriate handling.
Ensure tracking and documentation of the AE/SAE related correspondence creating set of information for future.
Supervises and collects, records and manages the safety issues arising during the post marketing phase.
Manages the communication and reporting to the Clients of safety issues arising during the post marketing phase.
Performs the reporting to the CAs, applicable ECs and other recipients of safety issues arising during the post marketing phase.
Keeps herself/himself professionally abreast of all scientific, regulatory and operative aspects relevant to the clinical projects she/he will be assigned.
Prepares and reviews Safety Plans and AE/SAE Reconciliation Plans 4 Participates, for the Safety section, to the system audit, qualification audit and project audit.
Education and Experience:
University Degree in scientific, medical or paramedical disciplines.
At least two years of safety experience is preferred.
Excellent understanding of safety regulations in EU Member States (e.g. ICH, CT3, MDD, AIMDD, MEDDEVs) and implementation of national laws.
Ability to research safety requirements in International and National Regulation.
Fluent in English. (oral and written)
Proficiency in additional languages, both written and spoken, will be considered an advantage.
Proficiency in Microsoft Office (e.g. Word, Excel, Outlook).
Our Benefits:
Flexible Working Hours
Full performance and development process with end of year reviews
Team events and end of year party
Employee satisfaction survey - your feedback is important for continuous improvement
Health Insurance
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!
Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
About the job
Apply for this position
Associate - Case Processing
ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as an Associate, Case Processing on a temporary basis.
Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career!
Main Job Tasks and Responsibilities:
Collects, records and checks for minimal requirements Serious Adverse Event (SAE) arisen during clinical investigations and during clinical trials.
Manages the generation of queries/questions in case of need of further information to complete or to understand the AE/SAE and manages the follow up for ensuring efficient control and information flow.
Performs the AE/SAE reporting to the Sponsor, guaranteeing smooth and efficient information flow.
Prepares the case narratives, CIOMS I Forms, SAE Forms and all other applicable forms in order to perform safety reporting.
Manages the Safety Database.
Can act as first of contact for the Sponsor for safety matter.
Can act as back up of the safety contact for the Sponsor for safety matter.
Can act as first point of escalation for the Sponsor for safety matter.
Performs the reporting of Suspected Unexpected Serious Adverse Reactions (SUSAR), arisen during clinical trials, to Competent Authorities (CAs), Ethics Committees (ECs) and other recipients ensuring compliance with applicable regulations and appropriate handling.
Manages the unblinding information.
Performs the reporting through EudraVigilance via EVWEB, if qualified.
Performs the periodic reporting to CAs, ECs and other recipients of safety documentation, ensuring compliance with applicable regulations and appropriate handling.
Performs the safety reporting of reportable safety issues (SAE) arisen during clinical studies with medical devices to CAs, ECs and other recipients, ensuring compliance with applicable regulations and appropriate handling.
Ensure tracking and documentation of the AE/SAE related correspondence creating set of information for future.
Supervises and collects, records and manages the safety issues arising during the post marketing phase.
Manages the communication and reporting to the Clients of safety issues arising during the post marketing phase.
Performs the reporting to the CAs, applicable ECs and other recipients of safety issues arising during the post marketing phase.
Keeps herself/himself professionally abreast of all scientific, regulatory and operative aspects relevant to the clinical projects she/he will be assigned.
Prepares and reviews Safety Plans and AE/SAE Reconciliation Plans 4 Participates, for the Safety section, to the system audit, qualification audit and project audit.
Education and Experience:
University Degree in scientific, medical or paramedical disciplines.
At least two years of safety experience is preferred.
Excellent understanding of safety regulations in EU Member States (e.g. ICH, CT3, MDD, AIMDD, MEDDEVs) and implementation of national laws.
Ability to research safety requirements in International and National Regulation.
Fluent in English. (oral and written)
Proficiency in additional languages, both written and spoken, will be considered an advantage.
Proficiency in Microsoft Office (e.g. Word, Excel, Outlook).
Our Benefits:
Flexible Working Hours
Full performance and development process with end of year reviews
Team events and end of year party
Employee satisfaction survey - your feedback is important for continuous improvement
Health Insurance
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!
Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.