Clinical Data Manager
Clinical Data Manager
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
POSITION SUMMARY:
The InHouse Clinical Data Manager will be responsible for a range of data management tasks contributing to the success of clinical trials and regulatory submissions in accordance with Good Clinical Practices and applicable regulations including the Code of Federal Regulations (CFRs). This position will be called upon to act with flexibility to take on additional trial management tasks directed by the clinical project manager as needed.
PRIMARY RESPONSIBILITIES:
- Support the organization and execution of data management activities for clinical trials including Case Report Forms (CRFs) and Electronic Data Capture (EDC) System.
- Manage the creation maintenance and validation of clinical databases to ensure data quality and integrity in accordance with GCP and applicable regulations.
- Conduct and supervise user acceptance testing for clinical trial EDC to ensure user and regulatory requirements are met.
- Develop and maintain EDC training materials for the training of study site personnel internal study personnel and thirdparty vendors where needed.
- Implement and oversee data validation processes to ensure data integrity and compliance with study protocols and industry standards.
- Development and maintenance of Data Management Plans for all Treace sponsored clinical trials.
- Manage and coordinate datarelated activities throughout the clinical trial lifecycle.
- Accurately and efficiently validate electronically captured data. Write clear queries on missing data and data points failing predefined range checks and/or logical checks. Lead efforts in building a standard query library for common database modules.
- Generate standard and ad hoc reports of EDC CRF or metric data for study team and management reporting.
- Lead the planning execution and tracking of data analysis projects ensuring they align with the study objectives.
- Collaborate with biostatistician during database locks and QC of clinical trial data in preparation of reporting data.
- Contribute to study protocols and study reports particularly as it relates to the development of tables listings and figures (TLFs) for study data.
- Prepare and ensure the accuracy and completeness of clinical trial data for regulatory submissions publications posters and presentations.
- Maintain and prepare for final archival of data management documentation relevant to the assigned clinical trials and assist the corporate archivist in assembling and archiving clinical trial data and study documentation.
Qualifications :
EDUCATION & EXPERIENCE REQUIREMENTS:
- 3 years of directly related data management experience or equivalent clinical research experience including work on medical device trials.
- BS or BA degree required preferably in a life sciencerelated discipline data management or a similarly related field.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Treaces Privacy Policy
It is Treaces policy not to discriminate against any applicant for employment or any employee because of age color sex disability national origin race religion veteran status or any other characteristic protected by applicable law. EEO/Disabled/Veterans Employer
Treace is a drug free employer.
Remote Work :
Yes
Employment Type :
Fulltime
Employment Type
Remote
Company Industry
Key Skills
- SQL
- Data Collection
- GCP
- Master Data Management
- R
- Data Management
- Clinical Trials
- User Acceptance Testing
- Data Warehouse
- SAS
- Oracle
- Data Analysis Skills
