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Project Data Manager

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Website Syneos Health

Highlights

  • 💡 Mid-Level 💡
  • 🇺🇸 Anywhere in the U.S. 🇺🇸

Summary

Ensures the contracted Data Management for clinical studies are carried out by the Company in accordance with the executed contract and the customer’s expectations.

Essential Functions

  • Acts as Project Leader on a stand-alone contract (“project”) for Data Management, to include:
    • Primary customer contact for all contracted Data Management;
    • Direct liaison with Finance and Contract department on required matters (e.g., invoicing, contract changes).
  • Acts as Functional Lead for Data Management on full service contracts to include:
    • Primary contact for internal liaison between Data Management and Company Project Management, Clinical Monitoring, and other functional groups on ‘full service’ contracts;
    • Liaison with Finance and Contracts groups via the Project Leader (e.g., concerning invoicing, contract changes).
  • Ensures launch, delivery and completion of all Data Management according to the contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations.
  • Manages changes of scope, budget, revenue recognition, and participation in monthly internal project reviews.
  • Monitors and communicates project progress to the customer and project team including use of project status reports and tracking tools/metrics.
  • Plans, manages, and requests resource as required for assigned studies.
  • Maintains a consistent, manageable workflow for Data Management project team by monitoring enrollment information and communicating with the project team to actively influence data collection.
  • Develops and maintains:
    • Data Management Plans;
    • Project Management Plans (for stand-alone contracts only);
    • Communication Plans (for stand-alone contracts only);
    • SAE Reconciliation Guidelines
    • Quality Plans; and other plans as delegated/required.
  • Assists in the negotiation and contracting process with outside vendors such as e-CRF/Diary vendors, CRF Printer, and IVRS vendors.
  • Maintains documentation on an ongoing basis and ensures that all filing is up to date.
  • Regularly reviews project files to ensure that all filing is up to date.
  • Manages the database freeze and lock processes and procedures.
  • Ensures that all applicable documents and databases (data sets) are archived or returned to the customer appropriately.
  • Coordinates user testing per User Test Plans developed for data entry screens, electronic edit checks, data listings, import/export programs, and medical coding.
  • Provides project-specific training for:
    • CRAs to be able to train site staff to use EDC system;
    • site staff to use EDC system;
    • project team in project specific requirements.
  • Manages Quality Control (QC) process for checks of CRF database versus Case Report Forms (CRFs) and Data Clarification Forms (DCFs):
    • specifies required CRF database listings;
    • Summarizes results and resolves issues from checks of such listings against CRFs and DCFs.
  • Schedules and requests data transfers/imports/exports to/from CRF/eCRF database and associated databases.
  • Reviews and approves
    • Project plans and guidelines for data validation, electronic data interchange, coding, CRF/eCRF screen, database design, user testing, CRF tracking, CRF/eCRF completion and other applicable project plans as delegated/required;
    • Specifications for listings and summaries (other than for statistical reporting requirements) from CRF databases, and external data sources;
    • Output from listings and summaries (other than for statistical reporting requirements) from CRF databases, and external data sources.
  • Participates in, and presents at internal, customer, third-party, and investigator meetings.
  • Plans for and creates necessary documentation to support internal and external audits; participate in such audits.
  • Participates in the development of departmental technologies, SOPs, processes, and procedures.
  • Develops and delivers applicable data management departmental training.
  • Trains and mentors data management staff.
  • Contributes to the Request for Proposal (RFP) and Request for Information (RFI) process. Prepares input for, and participates in proposal bid defense meetings.
  • Maintains proficiency in Data Management systems and processes through regular training. Takes the opportunity to network with colleagues for new and/or repeat business.

Qualifications

  • BA/BS in the biological sciences or related disciplines in the natural science/health care field.
  • Moderate clinical data management experience or an equivalent combination of education and experience.
  • Experience in Clinical Data Management practices and relational database management software systems.
  • Demonstrated staff leadership skills. Contract Research Organization (CRO) experience preferred.
  • Direct exposure to Oracle Clinical, Rave, or Inform systems.
  • Knowledge of medical terminology, clinical data, and ICH/Good Clinical Practices.
  • Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications.
  • Effective oral and written communication skills. Good organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail.
  • Ability to be flexible and adapt to change, to work independently, as well as part of a multi-disciplinary team.
  • Ability to make effective decisions and manage multiple priorities in a highly dynamic environment.

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