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Programming & Development Database Design & Administration

Clinical data team lead

$175/hr Starting at $25

•    Plans, manages, and requests resource as required for assigned studies.

•    Maintaining a consistent, manageable workflow for Data Management project team by monitoring enrolment information and communicating with project team to actively influence data collection.

•    Ensuring work carried out under the DM Alliance is in accordance with SOP’s and Working practices and agrees deviations to the DM Alliance service level agreements for the Franchise CSU/Disease Area.

•    Supports each clinical study team by ensuring data management plans and data handling activities are designed to meet project and protocol deadlines.

•    Leads development of Data Review and Oversight Plans; contributes to other key study level documents (e.g., protocols, SAPs).

•    Creates and review (electronic) Case Report Forms per Protocol and annotated Case Report Forms and sign-off on all data management plan (DMP) documents.

•    Participating in Study Kick Off meetings and Clinical Trial Team meetings for the assigned trials ensuring appropriate level of support, communication provided. 

•    Participated in designing Electronic Data Capture (EDC) databases and ensured they meet requirements for the entry and reporting of clinical data.

•    Develops test scripts and execution logs for User Acceptance Testing (UAT) and performed UAT on forms and edits for new studies in the Development phase.  

•    Potentially interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical support, drug safety, etc.) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality.

•    Validation and verification experience of EDC systems.

•    Testing and validating study specific Electronic Data Capture System (EDC).

•    Defining necessary validations or reports to ensure quality and timeliness of data collection.

•    Working in conjunction with Clinical Operations, Clinical Research, and other operations to ensure accurate, efficient, and complete data collection.

•    Mentor junior level staff on database management tasks and processes.

•    Ensuring all DM procedures executed with a high attention to detail, accuracy, and timelines.

•    Representing the DM function on project teams.

•    Proven leadership and expertise in a specific CDM task or technology.


About

$175/hr Ongoing

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•    Plans, manages, and requests resource as required for assigned studies.

•    Maintaining a consistent, manageable workflow for Data Management project team by monitoring enrolment information and communicating with project team to actively influence data collection.

•    Ensuring work carried out under the DM Alliance is in accordance with SOP’s and Working practices and agrees deviations to the DM Alliance service level agreements for the Franchise CSU/Disease Area.

•    Supports each clinical study team by ensuring data management plans and data handling activities are designed to meet project and protocol deadlines.

•    Leads development of Data Review and Oversight Plans; contributes to other key study level documents (e.g., protocols, SAPs).

•    Creates and review (electronic) Case Report Forms per Protocol and annotated Case Report Forms and sign-off on all data management plan (DMP) documents.

•    Participating in Study Kick Off meetings and Clinical Trial Team meetings for the assigned trials ensuring appropriate level of support, communication provided. 

•    Participated in designing Electronic Data Capture (EDC) databases and ensured they meet requirements for the entry and reporting of clinical data.

•    Develops test scripts and execution logs for User Acceptance Testing (UAT) and performed UAT on forms and edits for new studies in the Development phase.  

•    Potentially interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical support, drug safety, etc.) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality.

•    Validation and verification experience of EDC systems.

•    Testing and validating study specific Electronic Data Capture System (EDC).

•    Defining necessary validations or reports to ensure quality and timeliness of data collection.

•    Working in conjunction with Clinical Operations, Clinical Research, and other operations to ensure accurate, efficient, and complete data collection.

•    Mentor junior level staff on database management tasks and processes.

•    Ensuring all DM procedures executed with a high attention to detail, accuracy, and timelines.

•    Representing the DM function on project teams.

•    Proven leadership and expertise in a specific CDM task or technology.


Skills & Expertise

Data EntryData ManagementDatabase DesignDatabase DevelopmentLeadershipManagementMicrosoft AccessOracle

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