Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. Our network of 23,000 engaged professionals in 60 countries around the globe works with an unwavering commitment to patients, safety and ethics — ensuring a higher level of healthcare for people. For our biopharmaceutical customers, we help them navigate risk and seize opportunities in an environment where change is constant. Quintiles is consistently cited as the most favored contract research organization (CRO) in independent surveys of the bio pharma industry and was recently named “2009 CRO of the Year” by the prestigious SCRIP Awards.
Post : Assistant Medical Data Review Manager
Job Description
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
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
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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
Additional Information:
Experience: 3 years
Location: Karnataka-Bangalore
Education: MBBS; or Bachelor's degree
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Data Review
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