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Senior Clinical Data Manager/Programmer

Date: Apr 28, 2021

Location: Philadelphia, PA, US

Company: Spark Therapeutics

Join the Spark Team

 

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable – until now.

 

We don’t follow footsteps. We create the path.

Primary Duties

 

  • This role will be accountable to deliver technical support to Data Management team, review Data Validation Plans and Case Report Forms as per area of expertise as well as manage the production, review, and authorization of the database/system.
  • Clinical data management activities for key studies, ensuring timely delivery of complete, high quality and reliable clinical trial data for internal decision making, regulatory approval and market acceptance.
  • This role will lead the coordination of activities across biometrics, clinical operations and other business partners to ensure cohesive support to clinical trial data collection, documentation, review, and reporting.

 

 

Responsibilities

                  

%of Time

                            

                          Job Function and Description

 

 

       100%

  • Coordinate development of a standard data dictionary via the design, development, implementation, maintenance, and support clinical trials databases.
  • Implement data standards within a function or therapeutic area in accordance with industry standards.
  • Establish and oversee quality management processes by means of defining processes for data integration across various platforms and adding all external data sources such as ECG and lab within clinical database.
  • Establish strong communication pathways with the data operation team, project managers, statistical support, and other internal and external stakeholders (i.e., Project Management, DM Ops, Biostatistics, Medical Writers).
  • Serve as the escalation point-of-contact for unresolved data issues by identifying recurring problems and working with colleagues to initiate process improvement.
  • Provides a high level of expertise in data management to support
    • clinical studies, including leading the following processes: Case Report Form (CRF) design, database design, data management plan creation and update, data validation and review plans, query resolution, data transfers and reconciliation, SAE reconciliation, medical coding, and database lock.
  • Gathering of data collection requirements from various stakeholders for systems/applications deployed to collect clinical trial data, including
    • ensuring adherence to defined standards.
  • Oversee coordination of core clinical trial data tasks including: Case Report Form (CRF) development, development of edit checks and generation and resolution of data queries, and interim data reports.
  • Participate in the design of the Clinical Database as needed.
  • Perform Validation Programming, as needed, according to standards agreed to for each specific project.
  • Conduct or participate in user acceptance testing to ensure high quality  
  • Responsible for documentation that complies with database design and validation.
  • Ensuring effective quality oversight and management of external partners (e. g. Function Service Providers, CROs, technology providers, etc.)
    • performing data management services on behalf of Spark
  • Manage time and resource constraints across multiple projects.
  • Provide weekly status reporting related to data collection, cleaning progress and database lock process
  • Participate in departmental initiatives, as requested.
  • Participate in vendor evaluation and selection efforts.
  • Assist with implementation of new technology and initiatives.
  • Support data migration activities including data cleaning and adjudication processes, as needed.
  • Contribute to SOP development and updates.
  • Other duties as assigned

 

 

 

Education and Experience Requirements

 

 

  • Bachelor’s degree required with an advanced degree preferred.  Minimum of  8 years of clinical data management experience with a minimum of 3 years of demonstrated experience leading projects with increasing levels of responsibility and a thorough understanding of the processes associated with data management, database programming and reporting.
  • Experience in rare disease or a therapeutic area of interest to Spark (e.g. hematology, immunology, neurology) is not mandatory but preferred.
  • Familiarity with SQL, SAS and Spotfire preferred.
  • Thorough knowledge of the pharmaceutical industry and regulations applicable to data management and programming responsibilities.

 

 

Key Skills, Abilities, and Competencies

 

  • Strong written and verbal communication skills.
  • Competency in industry leading clinical platforms (e.g. Medidata Rave, Veeva) and well versed in industry trends and emerging technologies supporting data collection.
  • Solid understanding of CDISC standards used in database design (e.g. CDASH).

Understanding of medical coding dictionary structures (e.g. MedDRA, WHODrug).

 

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Nearest Major Market: Philadelphia