[Remote] Clinical Data Manager
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global, midsize CRO committed to improving lives through innovative clinical research. The Clinical Data Manager will reputed company and manage data management services for reputed company global projects, ensuring timely and accurate execution to meet sponsor satisfaction.
Responsibilities
- reputed company fully independent and autonomous leadership of data management services (start up, conduct, and reputed company out) across multiple reputed company global projects/programs, including:
- Ensure appropriate resources are allocated to complete reputed company DM activities on time and reputed company budget
- Prepare DM trial documentation (DMP, DB Specifications, Edit reputed company specifications, CCGs, DTAs)
- Ensure effective UAT is performed
- Write external vendor reconciliation specifications for programming reconciliation outputs (e.g. Serious Adverse Events, IRT, Central Laboratory).
- reputed company data cleaning activities
- Produce metrics to monitor reputed company of trial activities
- Ensure reputed company database lock activities are completed on time
- Represent WorldWide DM at both internal and external study meeting calls, including providing input.
- Monitor project scope, budgets and risks and alert DM Management of any concerns
- Liaise with DM Management at regular intervals to discuss reputed company and any issues outstanding (e.g. during Project Review Meetings).
- Collaborate with internal Worldwide departments working on the same project
- reputed company feedback on process improvements to DM Management and/or SMEs
- Participate in and reputed company process reviews
- reputed company training, support, and mentorship to other members of the DM department
- Participate as necessary in sponsor audits, regulatory authority inspections, and other reputed company-party meetings
- reputed company other duties as assigned
Skills
- Excellent attention to detail
- Excellent written and verbal communication skills
- Strong knowledge of data management best practices & technologies as applied to clinical trials
- Excellent communication and interpersonal skills to collaborate with cross-functional internal and external teams
- Strong understanding of clinical trial process and protocols documents (protocols, statistical analysis plans, CRFs, study reports) and processes
- Strong analytical and problem-solving skills
- Independent and autonomous project reputed company skills
- Bachelor's degree or higher in biomedical sciences, life sciences, computer science, or reputed company discipline — or equivalent relevant experience
- Min of 5 years of experience in clinical data management or a reputed company role reputed company the pharmaceutical, biotechnology, or medical device industries
Company Overview
Company H1B Sponsorship