Clinical Data Management, Manager( medidata Application Support Engineer)

Ampstek; Connecticut; Remote; USD 80,000 - 100,000; Full time

Job summary

A leading company is seeking a skilled Medidata Application Support Engineer to provide application-level support for Medidata Clinical Cloud applications. This remote role involves troubleshooting, collaborating with teams, and ensuring compliance with clinical standards. Ideal candidates will have hands-on experience with Medidata products and strong problem-solving skills.

Qualifications

• 2+ years of experience supporting Medidata applications.
• Strong knowledge of clinical trial processes and regulations.

Responsibilities

• Provide Level 1 and Level 2 support for Medidata applications.
• Troubleshoot application issues reported by end-users.
• Collaborate with cross-functional teams including Clinical Operations.

Skills

Analytical Skills

Problem-Solving

Communication

Education

Bachelor’s degree in Life Sciences

Bachelor’s degree in Information Technology

Tools

SQL

ServiceNow

Jira

Job description

Clinical Data Management, Manager( medidata Application Support Engineer)

Clinical Data Management, Manager( medidata Application Support Engineer)

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Job Title : Clinical Data Management, Manager( medidata Application Support Engineer)

Location : 100% Remote

Contract Job

Job Description:

Job Summary:

We are seeking a skilled and detail-oriented Medidata Application Support Engineer to provide application-level support for Medidata Clinical Cloud applications used in clinical trials. The ideal candidate will have hands-on experience with Medidata products such as Rave EDC, Rave RTSM, Rave Coder, or Rave CTMS, and possess strong problem-solving skills to resolve issues, support study builds, and ensure compliance with clinical and regulatory standards.

________________________________________

Key Responsibilities:

• Provide Level 1 and Level 2 support for Medidata applications including Rave EDC, RTSM, and other clinical systems.

• Troubleshoot application issues reported by end-users (e.g., CRAs, Clinical Data Managers, Sponsors).

• Collaborate with cross-functional teams including Clinical Operations, Data Management, and IT.

• Support study setup and configuration within Medidata tools.

• Monitor application performance and ensure uptime and availability.

• Manage tickets in issue tracking systems like Jira, ServiceNow, or Zendesk.

• Participate in system validation, testing, and documentation in accordance with GxP/21 CFR Part 11.

• Communicate with Medidata support or vendors for escalated issues.

• Develop and maintain user documentation, SOPs, and training materials.

• Assist in periodic audits and compliance reviews.

________________________________________

Required Qualifications:

• Bachelor’s degree in Life Sciences, Information Technology, or a related field.

• 2+ years of experience supporting Medidata applications (Rave, RTSM, etc.).

• Strong knowledge of clinical trial processes and regulations (GCP, ICH, 21 CFR Part 11).

• Experience in SQL for data investigation and issue resolution.

• Familiarity with ticketing tools like ServiceNow or Jira.

• Excellent analytical and problem-solving skills.

• Strong verbal and written communication skills.

Thanks, and Regards

9088605570|

www.ampstek.com

https://www.linkedin.com/company/ampstek/jobs/

Ampstek – Global IT Partner

Registered Offices:

North America and LATM: USA|Canada|Costa Rica|Mexico

MEA :South Africa|UAE|Turkey|Egypt

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Information Technology

• Industries

  IT Services and IT Consulting and Pharmaceutical Manufacturing

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