At Quintiles we help healthcare and biopharma companies improve their probability of success. We do this by connecting our scientific, therapeutic and analytics expertise with superior delivery. From advisory through operations, Quintiles and its affiliate companies is the world’s largest provider of product development and integrated healthcare services.As one of FORTUNE’s ‘Most Admired Companies’ in 2016, we offer great opportunities for a career in world-leading clinical research. Our global projects, innovative tools and industry leading customers combined with outstanding support from our leadership team and clear career mapping allows you to make a difference in patient health.
Job Title : Regulatory & Start-Up Specialist
Job ID : 1-1627217
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.
Qualifications
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.
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.
- If you want to make an impact in the global research market, where we are working to make a real difference in patient health, we ask you to apply now and join our team.
Primary Location: IND-Maharashtra-Mumbai
Organization: IND02 – India – CDS/Product Devel
