Clinical Data Manager

Atlanta, GA - USA

Monthly Salary: Not Disclosed

Posted on: 1 hour ago

Vacancies: 1 Vacancy

Job Summary

Position Summary
The Clinical Data Manager will integrate with both the data science and clinical operations teams to ensure the accuracy reliability security and usability of clinical data collected during clinical research. This position will play a critical role in ensuring collection of appropriate data to support regulatory submissions marketing claims for future applications of histotripsy. The Clinical Data Manager will report to the Director of Data Science.

Key Responsibilities

Works with key stakeholders to ensure appropriate data elements are captured during CRF development
Manages and develops Case Report Form (CRF)s for both pre- and post-market clinical studies
Works as a liaison with database vendor(s) to ensure proper database development and CRF implementation to the database specifications
Performs User Acceptance Testing (UAT) on all new database builds or updates to existing databases develops methods to improve and standardize UAT testing and manages HistoSonics feedback to the database vendor(s)
Drafts Data Management Plans (DMPs) and Data Review Plans for all pre- and post-market studies
Ensure quality management of data collection including the pre-specification of data queries and identification of new queries during the conduct of the trial
Interfaces with the Data Science team during formal statistical analyses to improve processes involving data accuracy
Works with key stakeholders to develop clinical metrics for external and internal purposes
Ensures and manages timely data locks in preparation for reporting and regulatory submissions
May assist in internal and external audits

Qualifications And Skills

Bachelors degree in scientific discipline
Minimum of 5 years medical device clinical study experience
Knowledge of and experience with GCP ICH GDPR and the FDA/EU regulatory environments
Understanding of CDM standards for medical devices (pre-market experience preferred)
Expertise in development validation and management of clinical study databases and experience with the software life cycle spanning from CRF design to database development and testing discrepancy management data quality review data analysis and final database archival
Experience as CRA in developing validating and/or administering clinical systems for data collection or clinical data analysis a plus
Excellent written and verbal communication skills
Strong analytical critical thinking and problem-solving skills with the ability to interpret and analyze data
Demonstrated collaboration and leadership abilities
Demonstrated ability to develop and maintain relationships internally and externally.
Demonstrated ability to effectively prioritize multiple tasks and deadlines and possess excellent follow through skills.
Demonstrated record of converting strategic plans to operational objectives
Demonstrated ability to handle shifting priorities in a fast-paced environment while maintaining communication with team and manager

Proficient in Microsoft Office Word and Power Point

Position SummaryThe Clinical Data Manager will integrate with both the data science and clinical operations teams to ensure the accuracy reliability security and usability of clinical data collected during clinical research. This position will play a critical role in ensuring collection of appropria...

Key Responsibilities

Works with key stakeholders to ensure appropriate data elements are captured during CRF development
Manages and develops Case Report Form (CRF)s for both pre- and post-market clinical studies
Works as a liaison with database vendor(s) to ensure proper database development and CRF implementation to the database specifications
Performs User Acceptance Testing (UAT) on all new database builds or updates to existing databases develops methods to improve and standardize UAT testing and manages HistoSonics feedback to the database vendor(s)
Drafts Data Management Plans (DMPs) and Data Review Plans for all pre- and post-market studies
Ensure quality management of data collection including the pre-specification of data queries and identification of new queries during the conduct of the trial
Interfaces with the Data Science team during formal statistical analyses to improve processes involving data accuracy
Works with key stakeholders to develop clinical metrics for external and internal purposes
Ensures and manages timely data locks in preparation for reporting and regulatory submissions
May assist in internal and external audits

Qualifications And Skills

Bachelors degree in scientific discipline
Minimum of 5 years medical device clinical study experience
Knowledge of and experience with GCP ICH GDPR and the FDA/EU regulatory environments
Understanding of CDM standards for medical devices (pre-market experience preferred)
Expertise in development validation and management of clinical study databases and experience with the software life cycle spanning from CRF design to database development and testing discrepancy management data quality review data analysis and final database archival
Experience as CRA in developing validating and/or administering clinical systems for data collection or clinical data analysis a plus
Excellent written and verbal communication skills
Strong analytical critical thinking and problem-solving skills with the ability to interpret and analyze data
Demonstrated collaboration and leadership abilities
Demonstrated ability to develop and maintain relationships internally and externally.
Demonstrated ability to effectively prioritize multiple tasks and deadlines and possess excellent follow through skills.
Demonstrated record of converting strategic plans to operational objectives
Demonstrated ability to handle shifting priorities in a fast-paced environment while maintaining communication with team and manager