- Title: Periodic Reporting Project Manager
- Code: RCI-03005
- Location: Bridgewater New Jersey (NJ) 08807
- Posted Date: 11/19/2020
- Duration: 5 Months
- Name:Ankit Shah
- Email: Ankit.Shah@rangam.com
- Phone: 908-704-8843 ✖ 210
The Periodic Reporting Project Manager will be expected to prepare and review Medicare Secondary Payer (MSP) Reports. Medicare Secondary Payer is a federally mandated report, submitted quarterly to identify medical events that occur to Medicare recipients during clinical trials. This position will also support periodic reporting (Annual Reports, PADERs, etc.)
- Prepare and Program Medicare Secondary Payer quarterly reports by:
- Maintaining compliance according to current Government and policies
- Contributing to the preparation, execution, reporting and documentation of the quarterly reports programming.
- Creating, managing and maintaining the programming specifications for the analysis datasets
- Contributing to the integration of reports and derived data into the MSP report while closely collaborating with MSP manager.
- Ensuring programming code meets company standards and are consistently structured to permit efficient programming and reporting.
- Setup/maintenance of a structured process for MSP in relation to the programming of clinical data aspect
- Interacting with Biostatistics, third party vendor, as well as internal and external clinical teams for the purpose of the quarterly submission or ad hoc submission if applicable/ as needed.
- Complying with policy on CMS reporting of Adverse Events & escalate any issues identified
- Working for process improvement while ensuring current regulations and guidance are adhered to.
- Track and analyze analyses errors to identify root causes and to recommend remediation strategies aimed at reducing error rates
- Provide back-up support in the generation of the specified regulatory documents; the candidate will be fully knowledgeable of the periodic reporting process
- Bachelor’s Degree in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field, preferred.
- Exceptional project management, including managing multiple complex projects from start to completion
- Demonstrated involvement in cross-functional teams and capabilities in planning, initiation, executing, and reporting activities.
- Demonstrated functional knowledge of Good Clinical Practices, Corporate policies and standard operating procedures as well as knowledge of applicable external regulatory requirements and guidelines
- Extensive knowledge of the regulatory requirements for various periodic reports, including knowledge of pharmaceutical clinical trial process and AR documentation requirements.
- Ability to work under tight timelines and excellent attention to detail is essential.
- Strong skills in Excel, and the ability to work with databases, e-rooms, and clinicaltrials.gov, etc. in an electronic environment. .
Other required skills and attributes:
-2 Years’ experience in SAS Programming preferred
-Demonstrated superb organizational, time management and communication skills (verbal and written)
- Demonstrated experience working on multiple projects simultaneously
- Strong interpersonal skills with the ability to interact with all levels of the organization
- Strong problem-solving, follow-through and decision-making skills for assigned programs with minimal supervision
-Advanced SAS programming skills in a clinical data environment.
-Extensive understanding of relational databases and experience working with complex data systems.
-Advanced SAS Macro
-Submission and/or CDISC standards background not required
- Proven ability to work both independently and in a team setting, and to meet goals by managing timelines
-Medicare Secondary Payer experience