Senior Clinical Programmer (Rave & Veeva CDB Admin URL)

Description

Senior Clinical Programmer (Rave & Veeva CDB Admin URL)

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
  
  

Job Responsibilities

Medidata RAVE URL Administrator (SME Level)

Job Summary

The Medidata RAVE URL Administrator is responsible for governance, configuration, and lifecycle management of RAVE environments (DEV, UAT, PROD, TRAINING) across Functional Service Outsourcing (FSO) Biometrics global clinical trials. This role ensures secure, compliant, and efficient environment provisioning, acts as the primary SME and escalation point for URL-related issues, and partners with Medidata Vendor management, Clinical Programming, Data Science, and Study Operations to enable seamless study startup, maintenance and closeout.

Core Responsibilities

• Environment Governance, Provisioning & Configuration
• Define and maintain global standards for RAVE URL creation, naming conventions, and environment lifecycle (development → validation/UAT → production → archival).
• Create, configure, and validate study environments (DEV/UAT/PROD/TRAINING), including study URL setup, study duplication/cloning, and controlled migrations.
• Perform environment readiness checks (roles, permissions, system settings, integrations).
• Coordinate environments build activities with Clinical Programming, Data Science, RTSM, Coder, and other Medidata modules.
• Author, update, and enforce SOPs/Work Instructions for environment provisioning, URL requests, and change control.
• Drive process optimization and automation (e.g., templated request forms, scripts, and API-driven workflows) to reduce cycle times and errors.
• Support Software as Validation (SaaS) version impact analysis process.
• Access Management & Security
• Govern role-based access control (RBAC) across environments; ensure least privilege principles.
• Implement secure link distribution practices and manage credential hygiene.
• Partner with Information Security to ensure policy alignment (audit trails, incident response, and monitoring).
• Compliance & Quality
• Ensure adherence to GxP, GCP, 21 CFR Part 11, GDPR, and applicable data-privacy standards.
• Maintain audit-ready documentation (environment request forms, approvals, change logs, validation evidence).
• Perform periodic reviews of environments for security, data integrity, and decommissioning/archival readiness.
• Issue Triage & Escalation
• Serve as the first-line SME for environment/URL issues (access failures, misconfigurations, integration errors).
• Troubleshoot and coordinate escalations with Medidata Support and internal platform owners.
• Lead root-cause analysis and corrective/preventive actions (CAPA) for environment-related deviations.
• Stakeholder Engagement
• Partner with Study Teams, CP/DM Leads, RTSM/Coder SMEs to align environment strategy with timelines and milestones.
• Knowledge Management & Mentoring
• Develop playbooks, templates, and knowledge articles for repeatable, high-quality environment management.
• Train and mentor junior administrators and study team coordinators.
• Contribute to community of practice and continuous learning initiatives.
  
  

Required Qualifications

• Experience: 5–8 years in clinical systems/EDC administration; 3+ years hands-on with Medidata RAVE environment management.
• Technical: Deep understanding of RAVE architecture, environment lifecycle, roles/permissions, study cloning/migration, and integrations (e.g., CDS, Coder, RTSM).
• Compliance: Working knowledge of GxP/GCP, 21 CFR Part 11, GDPR, validation/CSV principles, audit trail expectations.
• Operational: Strong change control, documentation rigor, and stakeholder management.
• Soft Skills: Clear communication, structured problem-solving, and influence without authority across cross-functional teams.
• Preferred Qualifications
• Experience with automation (APIs, scripting) for environment provisioning and checks.
• Familiarity with clinical trial lifecycle, EDC data flows, and downstream systems (e.g., reporting/visualization tools).
• Exposure to global governance committees, SOP authorship, and CAPA leadership.
• Knowledge of Medidata RAVE modules (EDC, Coder, RTSM, eCOA) and standard integrations.
• Success Metrics / KPIs
• Provisioning SLA adherence: % of environment requests delivered on time (e.g., DEV/UAT in ≤5 business days; PROD in ≤10).
• Quality/compliance: zero major audit findings attributable to environment administration; CAPA closure within agreed timelines.
• Automation impact: % reduction in manual steps; cycle time improvements quarter-over-quarter.
• Stakeholder satisfaction: >90% positive feedback from Study Teams (post-provisioning surveys).
• Operational stability: Reduction in environment-related incidents and escalations.
• Competencies
• System & Platform Mastery – Navigates RAVE admin tasks confidently; anticipates downstream impacts.
• Risk & Compliance Mindset – Embeds controls and documentation; audit-ready at all times.
• Service Excellence – Proactive communication, predictable delivery, and empathy for study timelines.
• Continuous Improvement – Measures, iterates, and scales best practices and automation.
• Collaboration & Mentorship – Builds capability across teams, shares knowledge with clarity.
• Working Model
  
  

Supports global studies across time zones; may require on-call coverage during critical milestones (FPI, interim analysis, database lock). Partners closely with Clinical Programming, Data Science, QA/CSV, InfoSec, and Medidata.

• Provide consultation for complex studies (platform integrations, multi-country rollouts, version upgrades).
• Communicate environment status, risks, and remediation plans to leadership and governance forums.
  
  

Veeva CDB Administrator (Subject Matter Expert)

Position Overview

The Veeva CDB Administrator is responsible for the end‑to‑end administration, configuration, and operational oversight of Veeva Clinical Database (CDB) and its connected ecosystem, including Veeva EDC, Vault CDMS, Data Workbench, and associated integrations. This SME ensures efficient ingestion, harmonization, cleaning, and transformation of clinical trial data across all sources while supporting data managers, programmers, and study teams in achieving high-quality, submission‑ready data.

CDB provides automated discrepancy detection, centralized query management, durable ingestion engines, and a harmonized study backbone for multi-source clinical datasets. The CDB Admin ensures these capabilities are optimized and aligned with study and organizational data governance requirements.

Core Responsibilities

• Platform Administration & Study Enablement
• Administer and maintain Veeva CDB, Vault CDMS, and Data Workbench including user access, permissions, study roles, and security profiles.
• Configure access to Workbench Tab, EDC Tools, and job management capabilities required for CDB operation.
• Support study setup by enabling ingestion pipelines, common study backbone mapping, and configuration of durable data connections between EDC and 3rd‑party data sources.
• Data Ingestion, Harmonization & Integration
• Manage and monitor CDB’s Durable Ingestion Engine to ensure seamless loading of EDC, labs, eCOA/ePRO, imaging, RTSM, and external data sources.
• Validate incoming data for type/range/format compliance using automated consistency checks built into the CDB ingestion framework.
• Troubleshoot ingestion failures, mismatches, and metadata alignment issues and coordinate with vendors or internal programming teams.
• Data Cleaning, Automation & Query Oversight
• Oversee automated change detection, autochecks, and query automation in CDB ensuring discrepancies are identified, queries generated/closed, and redundant review is minimized.
• Support centralized query management via the spreadsheet‑like Data Workbench, enabling direct access to listings, queries, and subject-level data readiness trackers.
• Ensure data managers and reviewers can conduct real-time, concurrent review of all study data without reliance on external trackers.
• Clinical Data Transformation & Programming Support
• Enable and support use of Veeva Clinical Query Language (CQL) for data transformation, harmonization, and creation of downstream-ready data structures for biostats/programming teams.
• Configure no-code/low-code and custom export pipelines to deliver clean, concurrent data packages to downstream systems via FTP/API as needed.
• Assist with development and execution of automated data quality checks, validation rules, and transformation scripts.
• API Enablement & Technical Configuration
• Manage access and permissions for the CDB Workbench API, ensuring correct role assignments, All Sites access, and adherence to security requirements for API-driven endpoints.
• Support study teams and developers with API troubleshooting, endpoint configuration, environment variable setup, and authentication flows.
• Operational Monitoring & Study Health Reporting
• Monitor study progress, query status, data readiness, automated cleaning logs, and workflow completion using interactive dashboards and activity logs.
• Provide regular status updates to data management, medical review, and clinical operations teams regarding study data health and data lock preparedness.
• Cross‑Functional Collaboration & User Support
• Serve as the primary SME for all CDB/EDC/CDMS platform capabilities; provide guidance to data managers, clinical programmers, and external vendors.
• Troubleshoot platform issues and coordinate escalations through Veeva Product Support as required.
• Conduct user training on Workbench, ingestion workflows, query review, CQL usage, and best practices for multi‑source data management.
  
  

Qualifications & Experience

Must-Have

• 5+ years of experience in Clinical Data Management, EDC administration, or clinical programming with at least 2–3 years dedicated to Veeva CDMS/EDC/CDB.
• Hands‑on expertise with Veeva CDB, Data Workbench, EDC, and ingestion pipelines including handling multi‑source clinical datasets (labs, eCOA, ePRO, imaging, RTSM, etc.).
• Strong understanding of clinical data cleaning, discrepancy identification, query lifecycle, and review workflows.
• Working knowledge of CQL or similar data transformation/query languages.
• Experience with API-based integrations or supporting technical API users (Postman, JSON endpoints).
  
  

Nice‑to‑Have

• Experience with SAS, Python, R, or other programming languages used for clinical data transformation.
• Familiarity with SDTM concepts or downstream data structures.
• Prior experience enabling automated cleaning and advanced data workflows in modern CDMS platforms.
  
  

Core Competencies

• Strong analytical skills with the ability to interpret complex multi‑source datasets.
• High attention to detail, accuracy, and data integrity.
• Strong communication and cross-functional leadership skills.
• Ability to troubleshoot, diagnose, and resolve system or data pipeline issues swiftly.
• Comfort working in a fast-paced, automation-driven, cloud-based environment.
  
  

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Summary

The Medidata RAVE URL Administrator is responsible for governance, configuration, and lifecycle management of RAVE environments (DEV, UAT, PROD, TRAINING) across Functional Service Outsourcing (FSO) Biometrics global clinical trials. This role ensures secure, compliant, and efficient environment provisioning, acts as the primary SME and escalation point for URL-related issues, and partners with Medidata Vendor management, Clinical Programming, Data Science, and Study Operations to enable seamless study startup, maintenance and closeout.