Regulatory and Start-Up Specialist 1

Company:- IQVIA

Location:- Mumbai

Hospital & Health Care

Job Description

PURPOSE

• Perform tasks at country level associated with Regulatory, Start-up (RSU) and Maintenance activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines.
• May participate in feasibility and/or site identification activities.

RESPONSIBILITIES:-

•   Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Leadership and GICS.
• Ensure adherence to standard operating procedures (SOPs), work instructions (WIs), quality of designated deliverables and to project timelines. 
• Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members. 
• Prepare site regulatory documents, reviewing for completeness and accuracy.  Review, prepare and negotiate site contracts and budgets with sites, if applicable. 
• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information. 
• Review and provide feedback to management on site performance metrics.  Review, establish and agree on project planning and project timelines.
• Ensure monitoring measures are in place and implement contingency plan as needed. 
• Inform team members of completion of regulatory and contractual documents for individual sites. 
• Review, track and follow up the progress, the approval and execution of documents, including contracts, regulatory, ethics, ICF and IP Release documents, in line with project timelines. 
• Provide local expertise to RSU leads and Project team during initial and on-going project timelines planning. 
• Perform quality control of documents provided by sites. 
• May have direct contact with sponsors on specific initiatives. 
• May perform Site Selection Visits if a trained monitor.  May participate in feasibility and/or site identification activities.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:-

•   In-depth knowledge of clinical systems, procedures, and corporate standards. 
• Effective communication, organizational, planning and interpersonal skills. 
• Ability to work independently and to effectively prioritize tasks. 
• Ability to work on multiple projects.  Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines. 
• Knowledge of applicable regulatory requirements, including local regulations, SOPs and company’s Corporate Standards. 
• Understanding of regulated clinical trial environment and knowledge of drug development process.
•   Ability to establish and maintain effective working relationships with coworkers, managers and clients.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE:- 

• Bachelor’s Degree in life sciences or a related field and 1 year‘s clinical research or other relevant experience; or equivalent combination of education, training and experience.

Job Description:-

• PHYSICAL REQUIREMENTS  Extensive use of keyboard requiring repetitive motion of fingers. 
• Extensive use of telephone and face-to-face communication requiring accurate perception of speech.  Regular sitting for extended periods of time.  May require occasional travel.

-At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

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