Associate Director, Clinical Systems
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.
Summary:
The Associate Director, Clinical Systems will support and develop capabilities for clinical data acquisition and standardization, increase efficiency of database builds, data visualization, and enable compliance to CDISC standards (e.g. CDASH, SDTM) while implementing industry best practices.
Essential Duties & Responsibilities:
The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned.
Clinical Systems Support:
- Expert in clinical systems and platforms (e.g. Medidata, Veeva CDMS, Veeva CTMS, CliqSense, JReview) configurations, capabilities, and system behaviors. Lead and deliver new capabilities, innovative technical solutions and/or clinical system integrations that enable future proof study execution.
- Provide technical leadership focused on technology enablement for EDC, Data Visualization, and other data collection / display systems
- Technical support for system integration, patient facing technologies and data reporting tools (e.g., IRT, ePRO).
- Ensure continuous improvement of processes, tools and outputs to be used to facilitate advancement of study portfolio.
- Liaise with systems vendors to develop and maintain system environments to support the organization.
- Lead efforts to identify future system capability and enhancement opportunities.
Study Support:
- Technical study lead to work with study team counterparts on study deliverables from external partners (e.g. Functional Service Providers, CROs, technology providers) performing data collection and data visualization 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.
- Oversee the build, maintenance, and deployment of data visualizations to display clinical trial data, including configuring custom integrations if applicable.
- Manage 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, visualizations and the management of external data and reporting.
- Identify and resolve technical system issues which may negatively impact delivery of study databases and data visualizations. Escalate issues to leadership as needed.
Standards:
- Responsible for ensuring 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) are implemented
- 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 clinical systems performance metrics.
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 clinical systems.
- Participate in the development and implementation of new processes and procedures, updates SOPs as appropriate
- As needed, accountable for the management and development of direct reports including performance management and career development.
- Supports financial management of CDO vendors, i.e. budget and invoice review, forecasting of future work, etc.
- Encourage cross-functional team collaboration for consistency across projects
Supervisory Responsibilities:
- Potential supervision of Clinical Systems 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.
- 8 years of experience in clinical systems execution and support, including EDC, data visualization, and data standardization preferred
- Minimum 5 years of experience leading process management and innovation
- Experience leading technical cross-functional system and process initiatives required
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Knowledge, Skills, and Abilities:
- Expertise in the drug development process with proven expertise in clinical trial execution and data acquisition in a global arena
- Strong knowledge of Veeva and other industry leading data capture and reporting tools (e.g. Medidata Rave, CDMS, JReview, ClikSense, Spotfire, IRT, ePRO etc.) and well versed in industry trends and emerging technologies supporting data collection.
- Expert in clinical data standards related to capture, quality control and reporting of data ( e.g. CDISC)
- Strong communication skills; ability to work in a team environment with medical personnel, clinical monitors, statisticians, data managers and medical writers
- Ability to interpret end user requirements and develop appropriate data capture and visualization solutions
- 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.) Role model with high performance standards that exemplify professionalism
Physical Demands:
The physical demands described here are representative of those that must me met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Please see HR if you need assistance completing this section, this is an example and may be adjusted to suit job.
While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, reach with hands and arms and stoop. Close vision and the need to focus on computer screen, use of hands, fingers and wrist to type on keyboard and manipulate mouse.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Typical office setting, staff in cubicles, noise level is moderate with consistent printer, telephone ringing and conversation. Employee is located in private office.
Benefits:
- Medical, Prescription, Dental, Vision Coverage
- Flexible Spending Account & Health Savings Account with Company match
- Employee Assistance Program
- Mental Health Resources
- Disability Coverage
- Life insurance
- Critical Illness and Accident Insurance
- Legal and Identity Theft Protection
- Pet Insurance
- Fertility and Maternity Assistance
- 401(k) with company match
- Flexible Time Off (FTO) and 11 paid holidays
- Paid Parental Leave
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.
Agency Disclaimer:
Pacira Biosciences, Inc. (Hereafter, Pacira) does not accept unsolicited resumes from recruiters or employment agencies in response to the Pacira Careers page or a Pacira social media post. Pacira will not consider or agree to payment of any referral compensation or recruiter fee relating to unsolicited resumes. Pacira explicitly reserves the right to hire said candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Pacira.