Job Details

  • Title: Periodic Reporting Project Manager
  • Code: RCI-03005
  • Location: Bridgewater New Jersey (NJ) 08807
  • Posted Date: 11/19/2020
  • Duration: 5 Months
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  Job Description

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.)

Responsibilities:

  1. Prepare and Program Medicare Secondary Payer quarterly reports by:
    1. Maintaining compliance according to current Government and policies
  2. Contributing to the preparation, execution, reporting and documentation of the quarterly reports programming.
  3. Creating, managing and maintaining the programming specifications for the analysis datasets
  4. Contributing to the integration of reports and derived data into the MSP report while closely collaborating with MSP manager.
  5. Ensuring programming code meets company standards and are consistently structured to permit efficient programming and reporting.
  6. Setup/maintenance of a structured process for MSP in relation to the programming of clinical data aspect
  7. 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.
  8. Complying with policy on CMS reporting of Adverse Events & escalate any issues identified
  9. Working for process improvement while ensuring current regulations and guidance are adhered to.
  10. Track and analyze analyses errors to identify root causes and to recommend remediation strategies aimed at reducing error rates
  11. Provide back-up support in the generation of the specified regulatory documents; the candidate will be fully knowledgeable of the periodic reporting process

Minimum Qualifications:

  1. Bachelor’s Degree in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field, preferred.
  2. Exceptional project management, including managing multiple complex projects from start to completion
  3. Demonstrated involvement in cross-functional teams and capabilities in planning, initiation, executing, and reporting activities.
  4. Demonstrated functional knowledge of Good Clinical Practices, Corporate policies and standard operating procedures as well as knowledge of applicable external regulatory requirements and guidelines
  5. Extensive knowledge of the regulatory requirements for various periodic reports, including knowledge of pharmaceutical clinical trial process and AR documentation requirements.
  6. Ability to work under tight timelines and excellent attention to detail is essential.
  7. 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