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Senior Clinical Data Manager - HYBRID - Mississauga, Canada
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#540614
Full Time
Job Description
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 a Senior Data Manager at Mississauga, Canada in a HYBRID model on a permanent basis.
Join our team: you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career!
Summary:
The Senior Data Manager is responsible for leading and managing Data Management projects, ensuring that study deliverables adhere to timelines and quality standards. The position involves developing and maintaining Data Management Plans (DMPs), designing electronic Case Report Forms (eCRFs), and overseeing database specifications. Responsibilities also include performing user acceptance testing (UAT), conducting data reviews, and mentoring junior Data Managers.
Responsibilities:
Lead multiple Data Management projects and ensure study deliverables meet timelines and quality standards.
Participate in the review of clinical research documents (e.g., protocols, Case Report Forms (CRF), reports and statistical analysis).
Develop Data Management Plan (DMP); maintain DMP throughout lifecycle of study project and ensure DMP is followed according to study design and requirements.
Develop electronic Case Report Form (eCRF) and/or paper CRF.
Develop database (DB) clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, and query logic and data validations.
Lead EDC DB specification process.
Develop or review Data Transfer Agreement(s) (DTAs) with external data vendors and/or core labs.
Reconcile electronic data transfers from external vendor(s).
Develop User Acceptance Testing (UAT) Plan and create and maintain all UAT documents, including but not limited to edit check document, issue logs, UAT summary report.
Lead and perform UAT of database and edit checks.
Maintain and track electronic data capture (EDC) system user management across allocated clinical trials, including but not limited to, compiling master user lists and activating/deactivating user accounts.
Perform site/clinical research associate (CRA) training and create user guides.
Perform data review according to the Data Review Plan (DRP) and Data Validation Plan (DVP).
Deliver high quality clinical data within EDC system to ensure successful freeze/lock as appropriate for statistical review, interim review, and or final database lock.
Perform unfreeze/unlock procedures if required.
Assist in defining and/or create data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit.
Work to maintain/improve client satisfaction by ensuring high quality service, communication and management of clinical data.
Mentor other Data Managers and provide trainings to new hires.
Coordinate the archiving of study databases and related documents.
Perform close-out audit, as specified, for closing of study trial in EDC or other clinical data management databases.
Lead adverse event (AE)/serious adverse event (SAE) data reconciliation between the safety database and clinical database.
Assist and provide input into study and project level data analysis plan.
Coordinate and communicate with DB vendors on consistent basis to address Clinical Team's requests, project plans, and/or eCRF development activities.
Participate in the preparation and presentation of data, when applicable.
Skills & Qualification:
Bachelor's degree in a science related field.
At least 5 years data management and/or related work experience in a medical device or pharmaceutical industry/company is preferred.
Working knowledge of Good Clinical Practices, clinical research, clinical trial process and related regulatory requirements and terminology.
Working knowledge of clinical database applications such as EDC.
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.
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 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.
#LI-PR1 #Hybrid #Senior
ClinChoice Canada Inc. is proud to be an equal opportunity employer, valuing and respecting diversity. We are committed to inclusive, barrier-free recruitment and selection processes. We will accommodate the needs of qualified applicants under the Human Rights Code and the Accessibility for Ontarians Disabilities Act, in all aspects of the hiring process, upon request by calling + 1 (647)724-570+ x 301.
We thank all applicants for their interest; however, only those being considered for an interview will be contacted. In accordance with Federal Personal Information Protection and Electronic Documents Act ("PIPEDA") , personal information is collected under the authority of the Act and will only be used for candidate selection.
Join our team: you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career!
Summary:
The Senior Data Manager is responsible for leading and managing Data Management projects, ensuring that study deliverables adhere to timelines and quality standards. The position involves developing and maintaining Data Management Plans (DMPs), designing electronic Case Report Forms (eCRFs), and overseeing database specifications. Responsibilities also include performing user acceptance testing (UAT), conducting data reviews, and mentoring junior Data Managers.
Responsibilities:
Lead multiple Data Management projects and ensure study deliverables meet timelines and quality standards.
Participate in the review of clinical research documents (e.g., protocols, Case Report Forms (CRF), reports and statistical analysis).
Develop Data Management Plan (DMP); maintain DMP throughout lifecycle of study project and ensure DMP is followed according to study design and requirements.
Develop electronic Case Report Form (eCRF) and/or paper CRF.
Develop database (DB) clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, and query logic and data validations.
Lead EDC DB specification process.
Develop or review Data Transfer Agreement(s) (DTAs) with external data vendors and/or core labs.
Reconcile electronic data transfers from external vendor(s).
Develop User Acceptance Testing (UAT) Plan and create and maintain all UAT documents, including but not limited to edit check document, issue logs, UAT summary report.
Lead and perform UAT of database and edit checks.
Maintain and track electronic data capture (EDC) system user management across allocated clinical trials, including but not limited to, compiling master user lists and activating/deactivating user accounts.
Perform site/clinical research associate (CRA) training and create user guides.
Perform data review according to the Data Review Plan (DRP) and Data Validation Plan (DVP).
Deliver high quality clinical data within EDC system to ensure successful freeze/lock as appropriate for statistical review, interim review, and or final database lock.
Perform unfreeze/unlock procedures if required.
Assist in defining and/or create data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit.
Work to maintain/improve client satisfaction by ensuring high quality service, communication and management of clinical data.
Mentor other Data Managers and provide trainings to new hires.
Coordinate the archiving of study databases and related documents.
Perform close-out audit, as specified, for closing of study trial in EDC or other clinical data management databases.
Lead adverse event (AE)/serious adverse event (SAE) data reconciliation between the safety database and clinical database.
Assist and provide input into study and project level data analysis plan.
Coordinate and communicate with DB vendors on consistent basis to address Clinical Team's requests, project plans, and/or eCRF development activities.
Participate in the preparation and presentation of data, when applicable.
Skills & Qualification:
Bachelor's degree in a science related field.
At least 5 years data management and/or related work experience in a medical device or pharmaceutical industry/company is preferred.
Working knowledge of Good Clinical Practices, clinical research, clinical trial process and related regulatory requirements and terminology.
Working knowledge of clinical database applications such as EDC.
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.
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 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.
#LI-PR1 #Hybrid #Senior
ClinChoice Canada Inc. is proud to be an equal opportunity employer, valuing and respecting diversity. We are committed to inclusive, barrier-free recruitment and selection processes. We will accommodate the needs of qualified applicants under the Human Rights Code and the Accessibility for Ontarians Disabilities Act, in all aspects of the hiring process, upon request by calling + 1 (647)724-570+ x 301.
We thank all applicants for their interest; however, only those being considered for an interview will be contacted. In accordance with Federal Personal Information Protection and Electronic Documents Act ("PIPEDA") , personal information is collected under the authority of the Act and will only be used for candidate selection.
