A Clinical Supervisor or Manager supervises staff and manages services in a clinical program. May provide clinical supervision for nursing, counseling or home health care staff. Works to ensure quality patient care. Trains and develops clinical staff and manages clinical program budgets.
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)
