Senior Clinical Data Manager/Principal Clinical Data Manager

Posted 7 days agoViewed

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📍 Location: UK, Spain, Hungary, Poland, Romania, Serbia, Slovakia

🏢 Company: Precision for Medicine

🗣️ Languages: English

🪄 Skills: SQLSAS EGData entryData modelingData management

Requirements:

Must have worked as a Lead Data Manager for a Clinical Research Organisation or Pharmaceutical company
Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
Excellent organizational and communication skills
Professional use of the English language; both written and oral
Experience in utilizing various clinical database management systems
Broad knowledge of drug, device and/or biologic development and effective data management practices
Strong presentational skills, ability to communicate effectively orally and in writing
Strong leadership and interpersonal skills

Responsibilities:

Primary Data Management (DM) contact for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner.
Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality.
Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.
May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications
Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File.
Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed.
Review and query clinical trial data according to the Data Management Plan
Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM
Run patient and study level status and metric reporting
Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
Coordinate SAE/AE reconciliation
Liaises with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables
Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues

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🏢 Company: Precision for Medicine

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Must have worked as a Lead Data Manager for a Clinical Research Organisation or Pharmaceutical company
Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
Able to handle a variety of clinical research tasks
Excellent organizational and communication skills
Professional use of the English language; both written and oral
Experience in utilizing various clinical database management systems
Broad knowledge of drug, device and/or biologic development and effective data management practices
Strong presentational skills, ability to communicate effectively orally and in writing
Strong leadership and interpersonal skills
Ability to undertake occasional travel

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Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs.
Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
May perform quality control of data entry
Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed.
Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
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Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.
May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications
Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File.
Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed.
Review and query clinical trial data according to the Data Management Plan
Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM
Run patient and study level status and metric reporting
Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
Coordinate SAE/AE reconciliation
Liaises with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables
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Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project
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May review Request for Proposals (RFP), proposals, provide project estimates
Provide leadership for cross-functional and organization-wide initiatives, where applicable
Trains and ensures that all data management project team members have been sufficiently trained
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Must have worked as a Lead Data Manager for a Clinical Research Organisation or Pharmaceutical company
Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
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Experience in utilizing various clinical database management systems

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Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner.
Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality.
Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.
May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications
Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File.
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Review and query clinical trial data according to the Data Management Plan
Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM
Run patient and study level status and metric reporting
Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
Coordinate SAE/AE reconciliation
Liaises with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables
Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
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Posted 7 days ago

📍 UK, Spain, Hungary, Poland, Romania, Serbia, Slovakia

🏢 Company: Precision for Medicine

🔧 Requirements

Must have worked as a Lead Data Manager for a Clinical Research Organisation or Pharmaceutical company
Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
Excellent organizational and communication skills
Professional use of the English language; both written and oral
Experience in utilizing various clinical database management systems
Broad knowledge of drug, device and/or biologic development and effective data management practices

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Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner.
Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed.
Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.
May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications
Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File.
Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed.
Review and query clinical trial data according to the Data Management Plan
Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM
Run patient and study level status and metric reporting
Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
Coordinate SAE/AE reconciliation
Liaises with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables
Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
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Posted 7 days ago

📍 UK, Spain, Hungary, Poland, Romania, Serbia, Slovakia

🏢 Company: Precision for Medicine

🔧 Requirements

Must have worked as a Lead Data Manager for a Clinical Research Organisation or Pharmaceutical company
Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
Able to handle a variety of clinical research tasks
Excellent organizational and communication skills
Professional use of the English language; both written and oral
Experience in utilizing various clinical database management systems
Broad knowledge of drug, device and/or biologic development and effective data management practices
Strong presentational skills, ability to communicate effectively orally and in writing
Strong leadership and interpersonal skills

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Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner.
Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality.
Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.
Specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications
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Review and query clinical trial data according to the Data Management Plan
Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM
Run patient and study level status and metric reporting
Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
Coordinate SAE/AE reconciliation
Liaises with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables
Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
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Must have worked as a Lead Data Manager for a Clinical Research Organisation or Pharmaceutical company
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Able to handle a variety of clinical research tasks
Excellent organizational and communication skills
Professional use of the English language; both written and oral
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Broad knowledge of drug, device and/or biologic development and effective data management practices
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Strong leadership and interpersonal skills
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Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner.
Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.
Specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications
Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File.
Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed.
Review and query clinical trial data according to the Data Management Plan
Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM
Run patient and study level status and metric reporting
Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
Coordinate SAE/AE reconciliation
Liaises with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables
Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues

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Must have worked as a Lead Data Manager for a Clinical Research Organisation or Pharmaceutical company
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Excellent organizational and communication skills
Professional use of the English language; both written and oral
Experience in utilizing various clinical database management systems
Broad knowledge of drug, device and/or biologic development and effective data management practices
Strong presentational skills, ability to communicate effectively orally and in writing
Strong leadership and interpersonal skills

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Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner.
Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality.
Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.
May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications
Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File.
Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed.
Review and query clinical trial data according to the Data Management Plan
Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM
Run patient and study level status and metric reporting
Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
Coordinate SAE/AE reconciliation
Liaises with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables
Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues

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