Clinical Data Manager
Posted on :
17-11-2022
Employer Active
The job posting is outdated and position may be filled
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
Responsibilities
- Provide input on Data Management related study plans including Data Management Plan (DMP), Data Validation Plan, Data Review Plan, CRF Completion Guidelines, and other study documents to ensure quality and standardization; may be responsible for updating DM documents to ensure they are up to date
- Contribute to development of initial and updated eCRF designs, including database UAT
- Assist in development of global library standards and comply with global library process
- Contribute to development and implementation of edit check specifications and work with database programmer on edit check development and validation
- Facilitate transfer of data from external vendors, which may include finalizing Data Transfer Agreement/ Specifications and verifying test data per specifications document
- Work with internal programmers to develop ad hoc SAS listings, patient profiles, and other outputs
- Run and review outputs and database study metrics; identify discrepancies to assist in data cleaning
- Participate in data reviews with clinical team to ensure accuracy, consistency, and reliability of data
- Review discrepancies in EDC system, monitor/facilitate resolution and closeout or re-query per study guidelines; note and communicate trends to clinical trial manager(s) for follow-up
- Facilitate identification and capture of Protocol Deviations, if applicable
- Reconcile external data to clinical study database and perform Serious Adverse Event reconciliation
- Work with study teams to ensure study databases are locked based on pre-defined criteria and established timelines
- Ensure DM procedures and processes are adhered to in a consistent manner
Requirements:
- At least 3+ years of clinical data management experience in the pharma/biotech industries
- Experience with DM activities including Database Build, Study Startup, Study Conduct, and Database Closure
- Hands on experience with Medidata RAVE is required and experience using ad hoc query tools required (J Review, other desired)
- Experience in CRO and vendor management is a huge plus
- Experience with multiple phases of clinical development highly desirable
- Associates Degree or higher is required, bachelor's degree is preferred
Employment Type
Full Time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
