Medical Data Review Mgr

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.

Essential Functions
Conduct in-stream data trend analysis in support of data quality and integrity (includes protocol compliance and targeted review of patient data)
Ensure data quality focus to audit readiness with Clinical Compliance and Systems Validation Compliance. .
Define data capture requirements in line with protocol and reporting needs.
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
Provide therapeutic area/indication training for the project clinical team.
Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
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.

Qualifications
Other Medic with 5 year college degree or MBBS Req
Bachelors Degree Clinical, biological, mathematical sciences, or related field, or nursing qualification, with 7 years of relevant work experience Req
Equivalent combination of education, training and experience in lieu of degree Req
Experience in clinical data sciences at a CRO, pharmaceutical company or other medical environment with demonstrated leadership experience Req
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
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