Summary of this EDC Programming Role:

The Senior / Principal EDC Programmer leads Electronic Data Capture (EDC) database development activities for Clinical Data Operations across all clinical studies.

The EDC Programmer will be responsible for ensuring Rave study level deliverables are completed on time, with a high degree of quality, and in accordance with client’s processes. S/he will provide technical support on core business packages including but not limited to iMedidata, Classic Rave, Rave EDC, BO4 and supplemental packages.

Essential Knowledge/Experience/Qualifications Required for this Role:

• Experience with Medidata Coder, Lab Administration, and Automated Serious Adverse Event reporting modalities (Rave Safety Gateway).

• Advanced experience using SAS and SQL, C#, Crystal Reports, Business Objects, BO4 and other business intelligence tools is required.

• Experience with or advanced knowledge about clinical database/EDC systems (ex. Medidata Rave, Veeva EDC, Oracle InForm, Medrio, etc.)

• Experience with reporting tools such as J-Review, Spotfire, and/or Cognos

Minimum Education/Experience:

• 5-10 years of clinical database/EDC programming experience (Medidata Rave), with at least 5 years of consecutive experience programming in different EDC platforms.

• 3+ years of Medidata Rave EDC/Veeva CDMS experience in study administration, site administration, and user administration

Skills:

• Strong interpersonal and project management skills.

• Must have strong computer skills with a proficiency in Microsoft Project, Excel, Word and PowerPoint.

• Excellent time management and organizational skills.

• Ability to work in a team environment.

• Highly developed problem-solving and analytical skills with strong attention to detail.

• Minimum of 3 years previous custom function programming experience is preferred.

• Must have excellent written and verbal communication skills, with a high ability to communicate standards related issues, options, and their impact to study teams and within data management are required.

Key Accountabilities of this Role include:

Oversight of activities

• Design/create, update, and test clinical databases including eCRF’s, folders, matrices, data dictionaries/code lists, unit dictionaries, edit checks/rules, derivations, custom functions, standard, and custom reports.

• Support data standards implementation by ensuring technical quality/system compliance, alignment to industry standards (e.g., CDISC) and regulatory guidance, consistency in the adoption of data standards across vendors, and provides support for study teams during data standards adoption and implementation.

• S/he must have knowledge of FDA/ICH guidelines and industry standard practices regarding the management of clinical trial data.

• S/he must have a working knowledge of FDA Guidance Documents: Computerized Systems Used in Clinical Trials, General Principles of Software Validation. Working knowledge of 21 C.F.R. Part 11 and CDISC Standards (CDASH, SDTM, and the creation of data mapping specifications and annotated CRFs).

• Remain apprised of changing industry regulations and CDISC versions and assesses the impact on the core standards.

• Create metric reports and data listings. Ensures appropriate methods are used for reporting (i.e. SAS, BO4, Jreview, etc.), metrics and analytics.

• Track and provide archival activities.

• Support with vendors holding client’s additional Rave URLs.

• Support post-production system modifications (e.g. database migrations)

• Participate in UAT and validation tasks related to EDC build with strong attention to detail and timelines.

• Perform system integration activities, application updates, and user acceptance testing.

• S/he must have demonstrated problem solving abilities and project and organizational skills.

• Perform user and site administration to include assignment of roles, permissions, and eLearning requirements

• S/he must have excellent written and verbal communication skills, with a high ability to communicate standards related issues, options, and their impact to study teams and within data management are required.

Collaborative relationships

• Working closely with Data Management across the life cycle of study start-up and all database modifications and is responsible for coordinating and supporting technical aspects of the EDC build, including CRF development, edit check specification and programming, dynamics, custom functions, and report programming, utilizing client’s data standards and global library.

Compliance with Parexel standards

• Complies with required training curriculum

• Completes timesheets accurately as required

• Submits expense reports as required

• Updates CV as required

• Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements