What does a BioPharm systems ASCEND specialist do?
A BioPharm Systems ASCEND specialist configures and validates the ASCEND clinical trial management system accelerator built on Oracle Siebel. This role translates complex clinical trial requirements into a working software environment that tracks study progress, site performance, and patient data. The specialist manages the full implementation lifecycle from initial setup through user training and ongoing technical support. They ensure the system meets strict regulatory standards by generating detailed validation artifacts and maintaining operational documentation.
- Configure the ASCEND CTMS accelerator by mapping clinical trial workflows to Oracle Siebel fields and objects. This work involves setting up study templates, defining user roles, and customizing dashboards to match specific sponsor or CRO requirements. The specialist adjusts the pre-configured Oracle Accelerate solution to handle unique data capture needs without breaking core functionality.
- Author and execute validation suites to prove the system behaves correctly under regulated conditions. This process includes writing test scripts, running manual or automated checks, and documenting results in validation reports that satisfy FDA 21 CFR Part 11 guidelines. The specialist identifies defects during testing and works with developers to resolve issues before the system goes live for clinical use.
- Create and maintain standard operating procedures and database maps that describe how the configured environment stores and processes data. These documents guide internal teams and auditors through the system logic and data flow structures. The specialist updates these assets whenever configuration changes occur to keep the documentation accurate and useful for future troubleshooting.
- Train clinical operations staff on how to use ASCEND features for daily trial management tasks. This responsibility includes developing user guides, leading live training sessions, and answering questions about data entry or report generation. The specialist provides help desk support to resolve user errors and ensures adoption of best practices across study teams.
- Support hosting and deployment options for the ASCEND platform including On-Demand SaaS environments. The specialist monitors system performance during go-live phases and coordinates with infrastructure teams to manage upgrades or patches. They verify that data integrations with external labs or electronic data capture systems function correctly after any maintenance window.
How to hire a BioPharm systems ASCEND specialist on Upwork
Step 1: Post a job
Define your clinical trial management needs clearly to attract qualified candidates. Use the Job Post Generator powered by Uma™, Upwork's Mindful AI to draft a precise description. Describe your requirements in a few sentences and Uma drafts a job post for the role. You can write a new post, update a saved draft, or reuse an existing post.
- Specify experience with Oracle Siebel CTMS configuration and the Oracle Accelerate solution framework.
- List required deliverables such as validation suites, SOPs, and database maps for the ASCEND environment.
- Clarify if the role involves On-Demand hosting support or on-premise implementation tasks.
Step 2: Evaluate candidates
Look for proof of successful ASCEND implementations and validation projects. Uma can run instant video interviews and build shortlists with side-by-side comparisons to speed up your review.
- Review portfolios for samples of validation documentation and standard operating procedures created for clinical trials.
- Check work history for specific mentions of BioPharm Systems ASCEND or Siebel CTMS accelerator projects.
- Verify experience in creating database maps that align with clinical data setup requirements.
Step 3: Interview your top choices
Discuss technical approaches to configuration and user support. Interviews can be scheduled and conducted within Upwork Messages with an immediate transcript and summary after each one.
- Ask how they configure pre-built ASCEND modules to match specific clinical trial workflows.
- Request examples of training materials they authored for end-users during past go-lives.
- Discuss their method for maintaining help desk support and resolving user issues post-deployment.
Step 4: Agree on scope and begin work
Set clear milestones for configuration, validation, and training deliverables. Use Upwork Messages and the contract workroom for communication and project management, plus identity verification, payment protection, hourly tracking, and project funds for security.
- Define milestones for completing validation suites and submitting associated documentation.
- Schedule specific dates for delivering SOPs and database maps for review.
- Outline the scope for user training sessions and ongoing help desk support hours.
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