Opening for the post of Asst Medical Data Review Mgr @ Quintiles
Quintiles is the world’s largest provider of biopharmaceutical development and commercial outsourcing services. We bring a fully integrated approach to build biopharma and life sciences solutions – from pipeline through portfolio to population health™. A career with Quintiles connects you to great opportunity to achieve professional success and impact healthcare around the world.
Description
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.
Purpose
Provide comprehensive Medical Review expertise to provide efficient, quality data management products that meet customer needs. Provide project management support in the areas of structured patient data review per clinician's perspective.
Responsibilities
• Serve as a Subject level Data reviewer (SLDR) and identify patient anomalies by performing Subject Level Data Review to ensure medical congruency/plausibility of a subject data per protocol.
• With minimal guidance, provide project management expertise working with clinical study teams, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise
• Maintain strong customer relationships
• With guidance, track service performance and provide leadership to identify root causes of issues and implement remedial actions
• Ensure timely follow-up and resolution of compliance issues
• Serve as Subject Matter Expert (SME)
• Serve as POC/ Back-up POC
• Continuously look for opportunities to improve efficiency of tasks and quality of deliverables
• Provide therapeutic area/indication training for the project clinical team.
• Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
• May act as a Clinical Data Scientist for performing data analytics by reviewing the visualizations and identify potential issues of concern
Required skills, knowledge & abilities
• Good understanding of clinical/medical data.
• Knowledge of Medical Terminology, Pharmacology, Anatomy, and Physiology
• Must have Medical but also an operational focus towards metrics and status information to take the appropriate actions to resolve.
• Excellent communication, interpersonal, customer service, and teamwork skills
• Excellent organizational and problem-solving skills
• Excellent project management skills and coaching skills
• Ability to work with minimal supervision, using available resources,
• Ability to work on multiple projects and manage competing priorities
• Strong customer focus skills
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
If you want to make an impact in the global research market, where we’re working to make a real difference in patient health, we ask you to apply now and join our team.
Qualifications
Minimum required education & experience
Medic with 5 year college degree or MBBS; or Bachelor's degree in clinical, biological area with 3 years of work experience in Clinical practice or clinical research related field; or equivalent combination of education, skills, and experience.
Experience in clinical data sciences at a CRO, pharmaceutical company or other medical environment with demonstrated leadership experience
Physical Requirements
• Extensive use of telephone and face-to-face communication requiring accurate perception of speech
• Extensive use of keyboard requiring repetitive motion of fingers
• Regular sitting for extended periods of time
Primary Location: India
Organization: IND02 - India - CDS/Product Devel
Posts
