Fresh Jobs at PAREXEL

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

go to method of application »

About This Role

• Parexel is currently seeking a Medidata Cloud Administrator to join us in South Africa, dedicated to a single sponsor.
• This role will be responsible for the administration and support of the Medidata cloud platform. It involves creating and managing user accounts, sites, ensuring proper access controls, and maintaining data integrity within the Medidata Rave EDC system. You will work closely with various teams to facilitate user access, compliance with training requirements, and the efficient management of user data. Additionally, you will support system validation processes to ensure that the Medidata platform operates in accordance with regulatory and compliance standards.
• Working as a Medidata Cloud Administrator at Parexel FSP offers tremendous long-term job security and prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and Pharma top 50. And we have an incredible pipeline of work.
• Expect exciting professional challenges in inspiring studies, but with time for your outside life.
• This will be a fully remote home-based position.

Responsibilities

• Create new user accounts within Medidata Rave EDC and other EDC systems such as Veeva CDMS systems.
• Ensure correct user roles and permissions are assigned based on study requirements.
• Collaborate with study teams to ensure accurate and timely user assignments.
• Periodic review of user access across the platform to ensure only valid users always have access to the studies.
• Administer and manage study and site assignments.
• Assign required eLearnings and report matrices to all studies in adherence to the internal procedures. Participate in system validation activities to ensure the Medidata platform meets regulatory and compliance standards.

Here are a few requirements specific to this advertised role.

• Bachelor’s Degree in a relevant field and a minimum of 2 years’ relevant experience (3 is preferred). An equivalent combination of education and experience may be considered.
• 3+ years of Medidata Rave EDC/Veeva CDMS experience in study administration, site administration, and user administration.
• Attention to detail and the ability to work individually, within a multi-disciplinary team.
• Strong English language written and verbal communication skills.
• Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications.