Clinical Data Manager

Clinical Data Manager

Job Descriptions:

Responsible for the accuracy and completeness of the clinical data collected during a clinical trial. At the trial level coordinate and perform the following acitivities:

- Development of the data specifications and eCRF design, including leading the review meeting
- User Acceptance Testing of eCRF and other tools
- Development of the Data Management Plan, including leading the review meeting
- Data review, query generation, data coding, electronic data reconciliation
- Identification of protocol deviations
- Develop the trial data specifications, including eCRF design, database requirements, eCRF completion guidelines and edit rules collaborating with cross functional groups
- Author the Data Management Plan
- Lead cross-functional review meetings for the data specifications, eCRF design and Data Management Plan
- Prepare for and ensure database lock according to the quality described in the Data Management Plan
- Review data according to the Data Management Plan, including generation of queries and review of data listings
- Reconcile data streams - such as electronic data transfers
- Perform SAE reconciliations
- Perform UAT activities
- Interact with ESP performing data management activities as appropriate

This position requires full understanding of data management processes and policies. The CDM is able to work independently towards the assigned goal.

The CDM would be required to interact effectively with a cross-functional team in order to manage the data management deliverables at the trial level. In trial start-up, the interactions with the Clinical Database Analyst (CDA) and Clinical Trial Management are essential to ensure the eCRF and other data streams, in addition to supporting documentation, are designed appropriately for the study. During trial conduct, the CDM must interact closely with the regional monitors working on the project to ensure timely collection of data and also with the CDA to monitor and reconcile the electronic data streams. During database lock, the CDM must work closely with the Clinical Trials team to ensure all data is collected and cleaned at the sites and with the statistical programmers and statisticians to ensure the database quality meets their expectations.

Within the department, the CDM would be expected to provide training and mentoring to CDMs. At times they might be asked to participate on process improvement initiatives or SOP reviews.

5-7 years experience
Required Experience:

Responsible for the accuracy and completeness of the clinical data collected during a clinical trial. At the trial level coordinate and perform the following acitivities:

- Development of the data specifications and eCRF design, including leading the review meeting
- User Acceptance Testing of eCRF and other tools
- Development of the Data Management Plan, including leading the review meeting
- Data review, query generation, data coding, electronic data reconciliation
- Identification of protocol deviations
- Develop the trial data specifications, including eCRF design, database requirements, eCRF completion guidelines and edit rules collaborating with cross functional groups
- Author the Data Management Plan
- Lead cross-functional review meetings for the data specifications, eCRF design and Data Management Plan
- Prepare for and ensure database lock according to the quality described in the Data Management Plan
- Review data according to the Data Management Plan, including generation of queries and review of data listings
- Reconcile data streams - such as electronic data transfers
- Perform SAE reconciliations
- Perform UAT activities
- Interact with ESP performing data management activities as appropriate

This position requires full understanding of data management processes and policies. The CDM is able to work independently towards the assigned goal.

The CDM would be required to interact effectively with a cross-functional team in order to manage the data management deliverables at the trial level. In trial start-up, the interactions with the Clinical Database Analyst (CDA) and Clinical Trial Management are essential to ensure the eCRF and other data streams, in addition to supporting documentation, are designed appropriately for the study. During trial conduct, the CDM must interact closely with the regional monitors working on the project to ensure timely collection of data and also with the CDA to monitor and reconcile the electronic data streams. During database lock, the CDM must work closely with the Clinical Trials team to ensure all data is collected and cleaned at the sites and with the statistical programmers and statisticians to ensure the database quality meets their expectations.

Within the department, the CDM would be expected to provide training and mentoring to CDMs. At times they might be asked to participate on process improvement initiatives or SOP reviews.

5-7 years experience
Keyword: Clinical Data Manager
From: Pharmaceutical Associates,LLC