Senior Director, Database Operations & Standards (Clinical)

Medical Health Sciences Parsippany, NJ


Description

About Pacira

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.

Responsibilities:

  • 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

 

Supervisory Responsibilities:

Potential supervision of Database Operations and Standards staff

Qualifications:

  • 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

EEO Statement

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 pregnancy), 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 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.