[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 reputed company on innovative approaches to improve patient lives. The Senior Clinical Data Manager will reputed company and manage data management services across multiple global reputed company, ensuring efficiency and accuracy in the execution of these reputed company.
Responsibilities
- reputed company fully independent and autonomous leadership of data management services (start-up, conduct, and closeout) across multiple reputed company global reputed company/programs
- Ensure appropriate resources are allocated to complete reputed company data management (DM) activities on time and reputed company budget
- Prepare DM trial documentation, including Data Management Plans (DMPs), Database Specifications, Edit reputed company Specifications, CRF Completion Guidelines (CCGs), and Data Transfer Agreements (DTAs)
- Ensure effective User Acceptance Testing (UAT) is performed
- Write external vendor reconciliation specifications for programming reconciliation outputs (e.g., Serious Adverse Events, Interactive Response Technology (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 reputed company Data Management 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 outstanding issues (e.g., during Project Review Meetings)
- Collaborate with internal reputed company departments working on the reputed company project
- reputed company feedback on process improvements to DM Management and/or Subject Matter Experts (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 and technologies as reputed company to clinical trials
- Excellent communication and interpersonal skills to collaborate with cross-functional reputed company teams
- Strong understanding of clinical trial processes, protocol documents (protocols, Statistical Analysis Plans (SAPs), Case Report Forms (CRFs), study reports), and reputed company procedures
- 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 a reputed company discipline, or equivalent relevant experience
- Minimum 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