Clinical Data Manager in Melville, NY at APEX Systems

Date Posted: 12/4/2019

Job Snapshot

  • Employee Type:
  • Location:
    Melville, NY
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:

Job Description

Job #:  1029030
Clinical Data Manager
Objectives or functions of this position:
  • Provide support for the Argus Safety System and other associated Drug Safety systems and data repositories.
  • Working with the Safety team, this individual will provide technical expertise, support and guidance facilitate the processing and submission of ICSRs, aggregate safety reports, safety analyses, and signal detection. 
  • Respond to time-sensitive requests from internal and external stakeholders such as Safety, R&D, QA, regulatory authorities and/or business partner ad hoc requests.

Key Roles & Responsibilities:
Decision Making (50%)
  • The candidate will maintain a global Adverse Event safety database, committed to generating reliable data that is accurate, complete and timely.
  • Coordinate distribution of relevant safety cases and data to other safety leads for reporting to regulatory authorities worldwide as well as internal reporting.
  • Ensure that PV/CV data query results are well defined and delivered in a timely and compliant manner.
  • Generate monthly and ad hoc review of signal detection and trending reports.
  • Provide regular internal reports to key stakeholders on the status of Adverse Event and reconciliation activities.
  • Reconcile CSV files from public registries (e.g., FDA (CAERS/FAERS), HC etc.).
  • Assist with internal and external audits of the Argus Safety System.

Independence of Action and Accountability (30%)
  • The candidate will support and maintain the proper function, maintenance and validation of global safety systems (Argus Safety System and other supporting systems) and adherence to company corporate policies and applicable global PV/CV regulations.
  • Accountable for the integrity of the Data they create and are involved with, including generation, recording, reporting and retention of data.
  • Establish, enhance and perform activities to ensure the integrity and consistency of safety data.
  • Supports changes to the systems under change control policy, including configuration changes and system upgrades.
  • Supports routine dictionary upgrades. Participates in the development and validation of required aggregate safety reports.
  • Contribute to ad hoc report specification, development, validation and implementation and maintain required validation documents.
  • Support the validation, implementation and maintenance of data transmission gateways with regulatory authorities and partners.
  • Provide timely flow of business intelligence information to users.
  • Provide technical support for existing reports, dashboards, or other tools (including signal detection and surveillance tools, safety data warehouse and reporting systems).

Problem Solving (20%)
  • With experience in IT and drug safety systems, the candidate will provide subject matter expertise in Argus safety system.
  • Act as a departmental resource by researching and consulting with others within or outside of the department to resolve issues within the Argus Safety System.

Leadership (10%)
  • Candidate will assist in the development of SOPs and/or updates of SOPs, Work Instructions, forms or other internal documents as needed for the Argus Safety System, and/or tools.
  • Will act as a training resource to staff on the use of Argus Safety System.
  • Candidate must possess the ability to work efficiently in a fast-paced environment, and deal effectively with changing priorities to support the business.

  • A bachelor's degree in Information Systems or related field with at least 5 years of IT experience with a minimum of 3 years in direct Drug Safety Systems support or equivalent combination of education, training & experience.
  • Knowledge of Drug Safety Databases required.
  • Oracle Argus Safety System is preferred.
  • Ability to write SQL code.
  • Expert knowledge of regulatory requirements as applied to single case and aggregate safety data management, E2B submissions and 21 CFR Part 11 compliance.
  • Expert knowledge with reporting platforms and data visualization tools (e.g., OBIEE, Tableau, Cognos, Spotfire) preferred.
  • Strong proficiency in Microsoft Office suite. 5% Travel time.

EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.