Note: The job is a remote job and is open to candidates in USA. Worldwide Clinical Trials is a global, midsize CRO committed to improving lives through innovative clinical research. The Clinical Data Manager will oversee and manage data management services for complex global projects, ensuring timely and accurate execution to meet sponsor satisfaction.
Responsibilities
- Provide fully independent and autonomous leadership of data management services (start up, conduct, and close out) across multiple complex global projects/programs, including:
- Ensure appropriate resources are allocated to complete all DM activities on time and within budget
- Prepare DM trial documentation (DMP, DB Specifications, Edit check 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).
- Oversee data cleaning activities
- Produce metrics to monitor progress of trial activities
- Ensure all 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 progress and any issues outstanding (e.g. during Project Review Meetings).
- Collaborate with internal Worldwide departments working on the same project
- Provide feedback on process improvements to DM Management and/or SMEs
- Participate in and lead process reviews
- Provide training, support, and mentorship to other members of the DM department
- Participate as necessary in sponsor audits, regulatory authority inspections, and other third-party meetings
- Perform 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 oversight skills
- Bachelor's degree or higher in biomedical sciences, life sciences, computer science, or related discipline — or equivalent relevant experience
- Min of 5 years of experience in clinical data management or a related role within the pharmaceutical, biotechnology, or medical device industries
Company Overview
Company H1B Sponsorship