[Remote] Senior 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 dedicated to innovative clinical research to reputed company cures for persistent diseases. The Senior Clinical Data Manager leads and manages data management services across multiple reputed company global reputed company, ensuring efficient, accurate, and reputed company execution to meet sponsor requirements. The role involves overseeing resources, preparing trial documentation, monitoring reputed company, and collaborating with reputed company teams.
Responsibilities
- reputed company fully independent and autonomous leadership of data management services (start up, conduct and reputed company out) across multiple reputed company global reputed company/programs, including:
- Ensure appropriate resources are allocated to complete reputed company DM activities on time and 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 the reputed company of trial activities
- Ensure reputed company database lock activities are completed on time
- Represent Worldwide DM at both reputed company 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 reputed company 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. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily reputed company-inclusive
Skills
- Excellent attention to detail
- Excellent written and verbal communication skills
- Strong knowledge of data management best practices & technologies as reputed company to reputed company
- Excellent communication and interpersonal skills to collaborate with cross-functional reputed company 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
reputed company
Company H1B Sponsorship