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: Medical Data Review Mgr -1613756
Job 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 expert skills as part of a Medical Data Review team to provide efficient, quality Medical Data Review products that meet customer needs; Provide Project management to the team in the area of clinical data review and viewed as an expert in data management; Drive the delivery of end-to-end study data quality and integrity; Provide medical, clinical, and scientific advisory expertise.
Responsibilities
Conduct in-stream data trend analysis in support of data quality and integrity (includes protocol compliance and targeted review of patient data) 1. Ensure data quality focus to audit readiness with Clinical Compliance and Systems Validation Compliance. .
2. Define data capture requirements in line with protocol and reporting needs.
3. Represent clinical data scientist at multi-disciplinary team meetings and external meetings.
4. Maintain strong customer relationships
5. With guidance, track service performance and provide leadership to identify root causes of issues and implement remedial actions
6. Ensure timely follow-up and resolution of compliance issues
7. Serve as Subject Matter Expert (SME)
8. Continuously look for opportunities to improve efficiency of tasks and quality of deliverables
9. Provide therapeutic area/indication training for the project clinical team.
10. Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
11. Manage staff in accordance with organization’s policies and applicable regulations. appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters.
Required skills, knowledge & abilities
- Good understanding of clinical/medical data
- Proven expertise in the proactive identification of issues
- Demonstrated ability to plan, organize and manage resources to bring to successful completion specific study or project goals and objectives in accordance with defined quality and time based metrics
- Proven ability to work within a matrix team environment requiring minimum level of supervision
- Attention to detail
- Interpersonal and analytical skills,
- Ability to represent clinical data scientist at multi-disciplinary team meetings and external meetings
- 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
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Qualifications
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Medic with 5 year college degree or MBBS; or Bachelor’s degree in clinical, biological, mathematical sciences, or related field, or nursing qualification, with 7 years of relevant work experience; or equivalent combination of education, training 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
Additional Information:
Experience: 7 years
Location: Karnataka-Bangalore
Education: B.Pharm, B.Sc, M.Pharm, M.Sc, BDS, BHMS, BAMS, MBBS
Industry Type: Pharma/ Biotech/Clinical Research
Last Date: 20th July, 2016
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