Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Our in-depth knowledge of non-opioid pain management, coupled with our passion for advancing patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results.
Why work with us?
Rarely do you have an opportunity to do work that really matters. What drives us is our mission. What makes us successful are our people. At Pacira, you are part of an inclusive culture that fosters collaboration, growth, and innovative thinking - a place where you can make an impact and help change the standard of care in non-opioid pain management. Be part of our movement, let's pursue excellence together.
The Senior Director, Data Operations & Standards will establish Database Operations and Standards as a key component of the Data Acquisition and & Strategic Operations function, including strengthening and aligning activities and capabilities to increase efficiency of database build and compliance to CDISC, while implementing industry best practices.
Create a center of excellence focused on database development specifications and data standards compliant with CDISC
Develop, maintain and implement governance of global library standards with a view toward re-usability and data integration
Develop medical coding approach that will allow for data consolidation across multiple EDC systems
Coordinate and align data structure with external organizations
Support the functional development of a risk management plan for audits with a goal of being inspection ready
Prioritize and develop scalable capabilities that will allow for future growth with a view toward identifying core/non-core activities and a plan to retain those of strategic importance in-house
Liaise with IT to identify, acquire, develop and maintain systems to support Data Acquisition & Strategic Operations including organizing and leading change management initiatives with broad impact
As needed, accountable for the management and development of teams including performance management and career development
Key strategic member of the Data Acquisition and Strategic Operations Leadership Team
Proactively anticipate problems, identify root causes and implement creative solutions
Collaborate effectively with other functions
Responsible for development and monitoring of performance metrics
Support VP in development of CRO sourcing strategy (including core/non-core definition) specific to Database Operations & Standards; actively work towards improvements over time that drive improvements in time, cost and quality
Participate in Study Team meetings as needed
Author, review and approve Database Operations & Standards related SOPs and Working Practices
In collaboration with IT and Biometrics, participate in the development and maintenance of the statistical computing environment to support global usage
Oversee the creation, maintenance, and validation standards for programming tools, outputs, and macros
Seek and continually implement best practices
Potential supervision of Database Operations and Standards staff
Bachelor's degree in Health Science, Pharmacy or Life Sciences from accredited college or university. Advanced degree preferred
BS/BA degree or equivalent in a relevant scientific discipline with a minimum of 15 plus years experience in database programming
Minimum 10 years of line management and project team leadership experience, as well as process management and innovation
Prior experience with clinical trials leading to NDA submissions
Experience leading technical cross-functional system and process initiatives required
BS/BA degree or equivalent in a relevant scientific discipline with a minimum of 15 plus years of experience in database development
Strong communication skills; ability to work in a team environment with medical personnel, clinical monitors, statisticians, data managers and medical writers
Knowledge of FDA/ICH guidelines and industry standard practices regarding data capture, clinical data structure, relational database, data processing, analysis programming, and data exchange with alternate formats
Detailed knowledge and experience in CRF design, central laboratories, programming databases, query resolution, data validation
Computer skills: detailed knowledge of multiple data management systems, basic familiarity with SAS datasets and conversion procedures
Understanding of the requirements for electronic data capture, SDTM, ADaM, Data Definition Table, and e-submission
Knowledge of statistical terminology, clinical tests, medical terminology and protocol design
Experience managing database developers/programmers
Proficient in programming languages / software
Advanced knowledge of reporting tools
Advanced knowledge of database design practices
Solid understanding of clinical data and pharmaceutical development
Ability to research new technologies and ensure alignment with regulatory agencies and industry standards
Leverage networks to achieve influence with others
At Pacira we are committed to intentionally cultivating a culture of inclusion where all feel welcomed and valued for their background, perspectives, and experiences. We hold one another accountable to promote trust and transparency in support of our communities and collective purpose.
Pacira is proud to be an Equal Opportunity Employer and does not discriminate against applicants because of race, color, religion, sex (including gender identity, sexual orientation, and p regnancy), national origin, age (40 or older), veteran status, disability or genetic information, or any other characteristic protected under applicable federal, state, or local law.
At Pacira Pharmaceuticals, controlling postsurgical pain is the key to improving patient outcomes. Our in-depth knowledge of the needs of the postsurgical pain market, coupled with our passion for delivering improved patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results.