Clinical Data Systems - Study Build Lead

Collabera; North Chicago (IL); On-site; USD 94,000 - 104,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Short/Long-term disability insurance

Paid parking/public transit

Paid time off

Job summary

Collabera is seeking a senior professional to provide technical leadership for the design, development, and delivery of clinical trial systems and data standards. You will support study and program level activities across clinical development programs and ensure systems meet protocol requirements, data standards, and regulatory expectations.

The role involves coordinating technical study build activities, system integrations, timelines, dependencies, and quality requirements, while contributing

Qualifications

• Bachelor’s degree or equivalent in Life Sciences, MIS, CS, or related field.
• Seven+ years of hands-on technical study build experience in electronic data capture systems.
• Experience with Medidata Rave is required.
• In-depth knowledge of clinical trial processes and data standards.
• Ability to influence stakeholders in a matrixed environment.

Responsibilities

• Lead technical study build activities within EDC clinical trial systems.
• Design and develop clinical trial systems based on protocol requirements and data standards.
• Coordinate delivery of new clinical systems and integrations.
• Monitor study progress, timelines, risks, and deliverables using PM tools.
• Mentor team members and contribute to process improvement initiatives.

Skills

CDISC SDTM

Regulatory compliance

Stakeholder influence

Analytical skills

Strong communication

Education

Bachelor’s degree in Life Sciences/Computer Science

Tools

Medidata Rave

Job description

Pay Range: $45 to $50 an hour.

Location: New Jersey preferred or near a company office; open to other locations (IL, MA, CA) for highly qualified candidates

Job Mode: Onsite

Contract Duration: 12 Months Contract, with potential extension for a second year; post- Performance Evaluation.

Job Summary:

• This role provides technical leadership for the design, development, and delivery of clinical trial systems and data standards.
• The position supports study level and program level activities across clinical development programs.
• The role ensures clinical systems meet protocol requirements, data standards, regulatory expectations, quality standards, and end user needs.
• The successful candidate will coordinate technical study build activities, system integrations, timelines, dependencies, and quality requirements.
• This position also contributes to process improvement, innovation, coaching, mentoring, and organizational development initiatives.

Key Responsibilities:

• Lead technical study build activities within electronic data capture clinical trial systems.
• Design and develop clinical trial systems based on protocol requirements, clinical data standards, and established methodologies.
• Ensure clinical system designs follow applicable standards and support effective functionality, user experience, and data flow.
• Coordinate the delivery of new clinical systems, system integrations, and required system changes.
• Use project management tools to monitor study progress, timelines, dependencies, risks, issues, and deliverables.
• Identify issues that may affect study timelines or quality and develop appropriate solutions.
• Collaborate with Clinical Data Operations and cross functional teams to achieve program and study objectives.
• Ensure assigned work products are aligned with upstream and downstream dependencies.
• Support consistency across therapeutic areas and clinical development programs.
• Ensure adherence to Good Clinical Practice, International Council for Harmonisation guidelines, applicable regulations, standard operating procedures, and quality standards.
• Stay current with evolving regulations, guidelines, and policies related to clinical development.
• Contribute to the development and continuous improvement of clinical system design methodologies.
• Coach and mentor team members and support their technical skill development.
• Lead or contribute to innovation and process improvement initiatives.

Required Qualifications:

• Bachelor’s degree in Business, Management Information Systems, Computer Science, Life Sciences, or equivalent experience.
• Seven or more years of hands on technical study build experience in electronic data capture systems.
• Required hands on technical study build experience with Medidata Rave.
• In depth knowledge of clinical trial processes.
• Required in depth knowledge of Clinical Data Acquisition Standards Harmonization.
• Strong knowledge of Study Data Tabulation Model.
• Experience with clinical trial system design, configuration, delivery, and integration.
• Demonstrated ability to influence stakeholders without direct authority.
• Experience working effectively in a matrixed environment.
• Strong communication, analytical, problem solving, and organizational skills.

Preferred Qualifications:

• Technical study build experience with Veeva EDC.
• Experience with Interactive Response Technology systems.
• Experience with electronic Patient Reported Outcomes systems.
• Experience with clinical system integrations.
• Experience leading clinical data technology or process improvement initiatives.

Benefits:

• medical insurance
• dental insurance
• vision insurance
• 401(k) retirement plan
• life insurance
• long-term disability insurance
• short-term disability insurance
• paid parking/public transportation
• (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)