Associate Director, Database Operations & Standards at Pacira Pharmaceuticals Inc in parsippany, New Jersey

Job Description:

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 Associate Director, Database Operations & Standards will support and develop capabilities for clinical data standardization, increase efficiency of database builds, and ensure compliance to CDISC (SDTM) while implementing industry best practices.

Essential Duties & Responsibilities:

Standards:

• Owner of the clinical data standards library. Responsible for performing the activities required to build out standard objects (e.g., eCRF forms, edit checks, eCRF entry guidelines, standard data review reports) that are compliant with CDISC (SDTM).


• Develop governance structure and lead governance committee for global library standards with a view toward re-usability and data integration.


• Collaborate with cross functional core roles (Data Managers, Medical Monitors, Statisticians, Programmers, etc.) to implement new or modified global library objects.


• Develop and monitor key standard Database Operations performance metrics.

Study Support:

• Technical study lead to work with CRO counterparts on study deliverables from external partners (e.g. Functional Service Providers, CROs, technology providers) performing database development services on behalf of Pacira.


• Oversee the build, maintenance, and deployment of study databases to collect clinical trial data, including configuring custom integrations if applicable.


• Managing work assignments to ensure timely delivery of study databases, data review reporting, external data management, and other study related technical components.


• Collaborate with Data Management to develop appropriate timelines for development and deployment of study databases including the management of external data and reporting.


• Identify and resolve issues which may negatively impact delivery of study databases. Escalate issues to leadership as needed.

Electronic Data Capture (EDC) and associated tools:

• Provide technical leadership (EDC & beyond) focused on technology enablement, continuous improvement to be used to facilitate advancement of study portfolio.


• Liaise with IT and EDC vendor to identify, acquire, develop, and maintain EDC systems to support the organization.


• Maintain overall health of EDC platform by overseeing future enhancement opportunities.


• Lead change management initiatives with broad impact.


• Expert in Medidata platform configurations, capabilities, and system behaviors. Lead and deliver new EDC capabilities, innovative technical solutions and/or clinical system integrations that enable future proof study execution.


• Technical support for system integration and patient facing technologies (e.g., IRT, ePRO).

General:

• Adhere to procedural documents and participate in reviewing, authoring and/or updating documents reflective of industry standards.


• Develop strong and productive working relationships with key stakeholders with the ability to think strategically across a broad portfolio and effectively express his/her views to senior management.


• Represent Pacira in interactions with key external partners as part of any committee or industry group relating to database development.


• As needed, accountable for the management and development of direct reports including performance management and career development.

Supervisory Responsibilities:
Potential supervision of Database Operations and Standards staff

Interaction:
The incumbent works closely with internal and external partners to provide database operations and standards expertise. The incumbent participates in interactions and presentations.

Education and Experience:

• BS/BA degree in a relevant scientific discipline required.


• Minimum of 5 years of experience in database development and programming.


• Minimum 5 years of project team leadership experience, as well as process


• management and innovation


• Experience leading technical cross-functional system and process initiatives required

Qualifications:

• Expertise in the drug development process with proven expertise in clinical trial execution and data acquisition in a global arena


• Expert in clinical data standards related to EDC, CDISC


• Strong knowledge of industry leading eCRF tools (e.g. Medidata Rave, ePRO etc.) and well versed in industry trends and emerging technologies supporting data collection.


• Strong communication skills; ability to work in a team environment with medical personnel, clinical monitors, statisticians, data managers and medical writers


• Strong project management skills


• Knowledge of FDA/ICH/GCP guidelines and industry standard practices regarding data capture, clinical data structure, relational database, data processing, analysis programming, and data exchange with alternate formats


• Proficient in programming languages / software


• Computer skills: detailed knowledge of multiple data management systems, reporting tools, basic familiarity with SAS datasets and conversion procedures


• Proficiency in Systems Development Lifecycle (SDLC) principles.


• Leverage networks to achieve influence with others


• Diverse and sufficient technical expertise to be a credible interface to all business partners (medical, development, commercial, regulatory & quality etc.)


• 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.