To Discuss more about this job opportunity, please reach out to Deepak Arya (LinkedIn URL - www.linkedin.com/in/deepak-arya-8a79aa22a/), email your updated resume at Email - deepak.arya@collabera.com. Thank you!

Pay Range: $45 to $50 an hour. 

Client Industry: Pharmaceutical

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:

• Master’s degree.
• 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: The Company offers the following benefits for this position, subject to applicable eligibility requirements: 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)