The Director, Clinical Data Operations is responsible for shaping, directing and leading all Data Management activities including Data Programming and Data Analytics/Data Science across the Digital Physiology business unit. The position will lead and retain a global team to ensure optimal performance and on-time, high quality study delivery for our clients. Will identify and lead initiatives (workstreams) aimed at transformative change for data collection, analysis, reporting and visualization for the organization resulting in driving operational excellence, lower cost, and improving overall staff / sponsor satisfaction and engagement. This includes maintaining therapeutic areas expertise but ensuring harmonization and consistency across TAs and functional areas to create a cohesive CDM team. The position will be responsible for achieving financial goals including but not limited to budget adherence, integration of new service(s) / value creation, and cost containment. The position requires a high level of innovative thought, proactive management, and problem-solving skills.

Primary Responsibilities

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Establish and drive global data management, data programming and data science strategy related to resourcing, technologies and processes to maximize efficiency, innovation and data quality.
• Conduct Analytical Deep-Dives: Perform in-depth analyses to proactively identify product opportunities, inform experimentation, and shape product roadmaps.
• Offer expert guidance and oversight on clinical data management practices.
• Lead Clinical Data Management and Clinical Programming including Scheduling, Resource assignment, Development, and Validation.
• Actively partner with the Commercial teams to ensure there is awareness and alignment of capabilities and offerings, Go to Market strategies are supported and reflected in our approach to service delivery, assist in bid defenses and strategic opportunity planning, product positioning and pricing and executive governance for key customer accounts.
• Develop a ‘Quality First’ culture that ensures all services are delivered in a manner that is consistent with industry best practices and regulatory requirements, including ensuring the effective remediation of quality issues as and when they occur.
• Increase customer satisfaction and overall profitability through improved execution of implementations.
• Improve the company's competitive position through improved execution, efficiency, and productivity.
• Motivate, coach, and lead a high performing, geographically dispersed team fostering a community of excellence, accountability, and continuous learning.
• As necessary, develop organization strategies to ensure service delivery capability supports company’s growing global footprint and customer demand for services.
• Develop, monitor, and continuously improve delivery methodologies, programs, and strategies to ensure effective, repeatable, and scalable, project management and resource utilization practices.
• At departmental, product and project level actively manage a P&L to include budgeting, forecasting, capacity planning and regular reporting and analysis on Key Performance Indicators (KPIs). Including working towards aggressive KPI targets.
• Foster global knowledge transfer, resource sharing, and standardization.
• Assess risks, anticipate, and remove bottlenecks and resolve escalations impeding customer success.
• Coordinate with other groups to ensure smooth execution, identify gaps and resolve.
• Serve as point contact for escalations for services customers, while coordinating with team.
• Provide success measurements and drive continuous improvement.
• Work closely to streamline and unify processes across platforms implementing best practices.
• Ensure staff are clear on their responsibilities under Clario SOPs and confirm their compliance and understanding at suitable intervals.
• Understand and contribute to the AI initiatives to optimize the workflow and data cleaning process.

Maintains Quality Service and Departmental Standards by

• Reading, understanding, and adhering to organizational Standard Operating Procedures (SOPs)
• Assisting in establishing and enforcing departmental standards
• Participating in user acceptance testing for new tools and software enhancements  
• Participating in the modification of company SOPs related to the department.

Secondary Responsibilities

Contribute to Team Effort by:

• Exploring new opportunities to add value to organization and departmental processes
• Helping internal and external customers to achieve results
• Communicating with different internal departments regarding image quality, deliverables, data discrepancies, and issues needing resolution
• Attending project specific, system and team focused trainings
• Training employees on imaging modalities and system applications, including proprietary and 3rd party
• Performing other duties as assigned

Qualifications

Education: 

• Bachelor’s degree computer science, life sciences or related field required. Master's degree preferred

Experience:

• 10+ years’ leadership experience in SAS Programming/data management required, including data import, data cleaning, and custom report generation
• 10+ years clinical trials experience within a CRO or pharmaceutical research organization
• Understanding of medical and/or clinical trial terminology required
• Proven ability in analyzing data
• Experience managing global teams
• Working knowledge of GCP, ICH guidelines and FDA regulations
• Working knowledge of other clinical trial data management tools such as Oracle Clinical, etc.
• Experience working with computer software including Word, Excel and Access preferred
• Experience with SDTM model a plus

Additional Skills:

• Strong interpersonal and communication skills, both verbal and written
• Strong organizational and leadership skills
• Goal oriented
• Ability to promote and maintain a positive and professional and positive attitude

                                                     

Working conditions

Travel: 0-5%

Lifting: 0-10 lbs.

Other: Computer work for long periods of time

This JOB description should not be deemed all-inclusive.  Additional requirements and expectations may be assigned.  At all times, employees are expected to adhere to company policies and company SOPs.

EEO Statement

Clario is an equal opportunity employer.  Clario evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.