Clinical Data Manager

Atlanta, GA - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Responsibilities:

The Clinical Data Manager actively participates in all aspects of the data management process from the development of project documentation system set-up User Acceptance Testing (UAT) and routine data review through database lock of clinical trials.
The CDM has a broad fundamental knowledge of the data management process and can plan manage and coordinate activities for assigned tasks with minimal guidance.
This person may have project level oversight as a study Lead Data Manager.
The core duties and responsibilities of the CDM are delineated below.
Manages data management duties to meet study timelines.
Review and may distribute/coordinate data management metrics listings and reports.
Performs scheduled and ad hoc data listing review and generates/resolves queries in EDC.
Performs external data reconciliation against EDC.
Performs Serious AE reconciliation according to SOPs and guidelines as applicable.
Provides DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables.
Generates and/or reviews/approves study documents (e.g. Data Management Plans Case Report Forms DB build specifications data transfer specifications SAE and/or external data reconciliation plans coding conventions laboratory data handling plan study protocols).
Reviews protocols for appropriate data capture including electronic Case Report Form (eCRF) design and external data vendors systems.
Reviews and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans and vendor specifications.
Maintains study DM related documents/files for inspection readiness.
May oversee data management CRO/service providers including manages and monitors the progress of data management activities with CROs and/or other service providers on assigned studies; build effective relationships with CRO/service provider counterparts.
May assist with the training of new employees and/or contractors (e.g. clinical data associates and/or junior clinical data managers working on the studies).
May participate in CRO/vendor selection process for outsourced activities.
May participate in the development review and implementation of departmental SOPs templates and processes.
Contributes to a professional working environment through exemplifying Core Values.

Requirements:

Bachelors degree.
At least three (3) years of CDM of Data Management experience in the pharmaceutical biotechnology or CRO industry; depth and exposure to DM related tasks considered in lieu of minimum requirement.
Requires solid knowledge of clinical data management principles clinical trials process and regulatory requirements.
Good working knowledge of ICH FDA and GCP regulations and guidelines.
Strong well-rounded technical skills (EDC systems MS Word Excel PowerPoint).
Experience with web-based Electronic Data Capture (EDC) clinical data management systems and industry wide thesauri such as MedDRA and WHO Drug.
Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment.
Ability to handle multiple project tasks and prioritize effectively.
Well organized and detail oriented.
Proven ability to work both independently and in a team setting.

Responsibilities: The Clinical Data Manager actively participates in all aspects of the data management process from the development of project documentation system set-up User Acceptance Testing (UAT) and routine data review through database lock of clinical trials. The CDM has a broad fundamental...

Responsibilities:

The Clinical Data Manager actively participates in all aspects of the data management process from the development of project documentation system set-up User Acceptance Testing (UAT) and routine data review through database lock of clinical trials.
The CDM has a broad fundamental knowledge of the data management process and can plan manage and coordinate activities for assigned tasks with minimal guidance.
This person may have project level oversight as a study Lead Data Manager.
The core duties and responsibilities of the CDM are delineated below.
Manages data management duties to meet study timelines.
Review and may distribute/coordinate data management metrics listings and reports.
Performs scheduled and ad hoc data listing review and generates/resolves queries in EDC.
Performs external data reconciliation against EDC.
Performs Serious AE reconciliation according to SOPs and guidelines as applicable.
Provides DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables.
Generates and/or reviews/approves study documents (e.g. Data Management Plans Case Report Forms DB build specifications data transfer specifications SAE and/or external data reconciliation plans coding conventions laboratory data handling plan study protocols).
Reviews protocols for appropriate data capture including electronic Case Report Form (eCRF) design and external data vendors systems.
Reviews and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans and vendor specifications.
Maintains study DM related documents/files for inspection readiness.
May oversee data management CRO/service providers including manages and monitors the progress of data management activities with CROs and/or other service providers on assigned studies; build effective relationships with CRO/service provider counterparts.
May assist with the training of new employees and/or contractors (e.g. clinical data associates and/or junior clinical data managers working on the studies).
May participate in CRO/vendor selection process for outsourced activities.
May participate in the development review and implementation of departmental SOPs templates and processes.
Contributes to a professional working environment through exemplifying Core Values.

Requirements:

Bachelors degree.
At least three (3) years of CDM of Data Management experience in the pharmaceutical biotechnology or CRO industry; depth and exposure to DM related tasks considered in lieu of minimum requirement.
Requires solid knowledge of clinical data management principles clinical trials process and regulatory requirements.
Good working knowledge of ICH FDA and GCP regulations and guidelines.
Strong well-rounded technical skills (EDC systems MS Word Excel PowerPoint).
Experience with web-based Electronic Data Capture (EDC) clinical data management systems and industry wide thesauri such as MedDRA and WHO Drug.
Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment.
Ability to handle multiple project tasks and prioritize effectively.
Well organized and detail oriented.
Proven ability to work both independently and in a team setting.