Opening for Assoc Mgr, Medical Data Review @ Quintiles Transnational - Bangalore, Karnataka
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 Project
Management and viewed as an expert in data management. To drive the
delivery of end-to-end study data quality and integrity. To provide
medical, clinical, and scientific advisory expertise.
Responsibilities
•
Conducts in-stream data trend analysis in support of data quality and
integrity (includes protocol compliance and targeted review of patient
data)
• Ensures data quality focus to audit readiness with Clinical Compliance and Systems Validation Compliance. .
• Defines data capture requirements in line with protocol and reporting needs.
• 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.
• 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)
• Continuously look for opportunities to improve efficiency of tasks and quality of deliverables
P a g e | 2
• Provides therapeutic area/indication training for the project clinical team.
• Attends Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
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
Minimum required education & experience
+5
yrs of work experience in Clinical practice or clinical research
related field, Bachelor's degree, or educational equivalence, in
clinical, biological, preferably a Medic with 5 year college degree or
MBBS.
A background 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
Qualifications
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 Project
Management and viewed as an expert in data management. To drive the
delivery of end-to-end study data quality and integrity. To provide
medical, clinical, and scientific advisory expertise.
Responsibilities
•
Conducts in-stream data trend analysis in support of data quality and
integrity (includes protocol compliance and targeted review of patient
data)
• Ensures data quality focus to audit readiness with Clinical Compliance and Systems Validation Compliance. .
• Defines data capture requirements in line with protocol and reporting needs.
• 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.
• 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)
• Continuously look for opportunities to improve efficiency of tasks and quality of deliverables
P a g e | 2
• Provides therapeutic area/indication training for the project clinical team.
• Attends Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
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
Minimum required education & experience
+5
yrs of work experience in Clinical practice or clinical research
related field, Bachelor's degree, or educational equivalence, in
clinical, biological, preferably a Medic with 5 year college degree or
MBBS.
A background 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
Click here to apply
