Temp Clinical Database Developer

Pay Range: $76.57 - $100.32/hr

Remote Role (US Only)

12 Month Contract

Oversee the development and/or technical activities of EDC databases built by CRO partners for assigned studies. Ensures all database build activities are performed according to Regeneron Processes (or CRO processes where applicable.

As a Temp Data Base Developer, a typical day may include:

Perform Clinical Database Development activities for all assigned studies:

• Create study on Medidata URL
• Rave User Administration, including AE/SAE alert and IRT account setup
• Project registration in Rave Coder
• AE/SAE alert code review
• eLearning mapping
• Assigning Rave Admin team access
• Requesting FTP folder mapping
• Clinical view setup and rebuilds/refreshes

Build early to late phase studies in Medidata Rave independently based on portfolio needs:

• Work with Clinical Study Team through Study Data Manager to implement comprehensive eCRF system in Rave Architect using the Global CRF Library and new unique CRFs per protocol requirements
• Program data validations in Rave Architect, including edit checks, dynamics, derivations, and custom functions prior to completion of eCRF build

Facilitate UAT process:

• Create UAT site and publish EDC system in UAT environment
• Invite Regeneron and CRO UAT participants via Cloud Administration
• Resolve reported issues during UAT until the system is deemed ready for go-live

Work with 3rd party vendor (if applicable):

• Perform EDC system integration and external data loads (e.g., IxRS, labs, etc.)
• Configure additional Medidata applications, including but not limited to Coder and TSDV

Manage post-production change activities:

• Use Rave Amendment Manager to perform migrations or quick publish changes

Provide high-level expertise:

• Offer guidance on Rave database builds to CROs and internal REGN teams
• Contribute to special projects requiring EDC input
• Participate in Database Development operational meetings with DM CRO partners

Fulfill SME role:

• Serve as Subject Matter Expert (SME) for one or more topics
• Develop and deliver training
• Provide ongoing support for Data Management and key stakeholders

Track milestones and deliverables:

• Escalate and follow up to resolution as necessary
• Contribute to the development of SOPs, Work Instructions, Guidance Manuals, and other Database Development tools

To be considered, you must meet the following requirements:

 Medidata Rave experience is required.
• Medidata Builder Certification is a plus.
• C# programming knowledge is a plus.
• TrialGrid knowledge is a plus.
• Demonstrates working understanding of all applicable regulations including 21 
CFR Part 11, ICH-GCP Guidelines and CDISC standards for data collections. 
• Demonstrates robust knowledge of Data Management & Database Development 
processes and industry best practices. 
• Demonstrates the ability to discuss the fundamental issues of all aspects of 
database development with manager. Ability to draw from wide-ranging 
experience to resolve complex issues. 
• Strong problem solving, project management, and communication skills 
required. 
• Ability to work effectively with virtual teams in matrix environment. 
• Good understanding of cross functional activities. 
• Confirmed problem-solving skills. 
• Solid ability to manage multiple and varied tasks with enthusiasm, prioritize 
workload with attention to detail. 
• Effective time management to meet objectives. 
• Good interpersonal, oral, and written communication skills. 
• Ability to adjust in a fast-paced environment.

This is a contract position at Regeneron with Magnit Global being the Employer.

To do our best work we need different viewpoints.  Therefore, we celebrate diversity and embrace inclusion. As an equal opportunity employer, we are dedicated to building a team that represents a variety of backgrounds, perspectives, and skills.  We strive to ensure that we maintain a positive and enriching work environment for all.

W2 only, no third party solicitation