Clinical Systems Specialist

Tandym Group; Woburn (MA); Remote; USD 80,000 - 100,000; Full time

Job summary

A biotech company in Massachusetts is offering a remote contract opportunity for a Clinical Systems Specialist. The role involves supporting the lifecycle management of clinical systems, collaborating with various teams, and ensuring compliance with clinical trial regulations. Candidates should have a Bachelor's Degree and at least 2 years of relevant experience in clinical systems.

Qualifications

• At least 2 years of experience with Clinical Systems (eCOA, eDiary, etc.).
• Solid understanding of Clinical Trial Operations & Regulations (GCP, 21 CFR Part 11).
• Strong problem-solving and time management skills.

Responsibilities

• Plan, design, configure, and deploy new clinical systems.
• Analyze system requirements and participate in user acceptance testing.
• Collaborate with stakeholders on system bug fixes and upgrades.

Skills

Problem-solving

Time management

Interpersonal skills

Communication

Attention to detail

Organizational skills

Education

Bachelor's Degree or equivalent

Bachelor's Degree in a Scientific or Technical field

Tools

Power BI

Databases

Job description

This range is provided by Tandym Group. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$59.00/hr - $59.00/hr

A biotech company in Massachusetts has a great remote contract opportunity for a Clinical Systems Specialist. In this role, the Clinical Systems Specialist will support the lifecycle management of clinical systems for Global Development Operations.

***To be considered for this opportunity, the qualified professional must be able to work on a W2 basis. ***

Responsibilities:

• Plan, design, configure, and deploy new clinical systems and enhancements to existing applications.
• Analyze system requirements, define user acceptance scenarios, and participate in user acceptance testing and system enhancements as necessary.
• Partner with IT, Quality Systems, and Global Development Operations stakeholders on all clinical system bug fixes and upgrades.
• Build dashboards and Power BI reports as needed.
• Collaborate with Clinical Operations and Clinical Vendor Management to manage vendor relationships, ensure system performance, and address issues.
• Develop Standard Operating Procedures (SOPs) and guidelines for clinical systems management and use.
• Provide training on various clinical systems as needed.
• Support administrative activities of clinical systems, such as user management.
• Partner with internal teams to analyze clinical systems and vendor performance to ensure contractual compliance.
• Support end users as a clinical systems subject matter expert.
• Perform other duties as required.

Qualifications:

• At least 2 years of experience with Clinical Systems (eCOA, eDiary, eConsent, CTMS, IRT, eTMF, etc.).
• Bachelor's Degree or equivalent.
• Solid understanding of Clinical Trial Operations & Regulations (GCP, 21 CFR Part 11).
• Experience or good knowledge of databases and reporting tools.
• Strong problem-solving and time management skills.
• Excellent interpersonal and communication skills (both written and verbal).
• High attention to detail and organizational skills.

Desired Skills:

• Bachelor's Degree in a Scientific or Technical field.

Seniority level

• Mid-Senior level

Employment type

• Contract

Job function

• Information Technology

Industries

• Technology, Information and Internet