Job details

Associate Director, Clinical Systems

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

By Pacira BioSciences, Inc.

Established in 1989 and headquartered in Parsippany, New Jersey, Pacira BioSciences, Inc. (Nasdaq: PCRX) is a provider of non-opioid pain management and regenerative health solutions manufacturing.

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Private

DEPARTMENTS

Operations

SENIORITY LEVEL REQUIREMENT

Senior

INDUSTRY

Health Care

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