Associate Director IT Business Partner

Please note that this position is based in Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.

This position will serve as a technology partner in the Research and Development (R&D) and Technology Development & Operations (TD&O) domains, providing technology leadership, operational support and project management for key projects. The IT Business Partner will work both on projects, as a critical team member, and with operational teams to help ease the introduction of new technologies and to maintain and further improve upon operational processes. The IT Business Partner will help define and document key processes, requirements, knowledge articles, and user documentation.

Primary Duties & Responsibilities:

• Act as operational lead for existing systems including holding recurring operational meetings with business partners and vendors, tracking and evaluating change requests, initiating change controls for implementation of changes, coordinating routine system patches and escalating issues as appropriate

• Work with Lead IT Business Partners to establish and enhance key relationships with business stakeholders and provide input to systems roadmaps

• Work with Business and IT Business Partners to help define and document business processes and requirements including, but not limited to, data flow, data storage, application usability, infrastructure, reporting and analytics

• Support IT project management in the implementation of technology solutions according to Acadia's IT governance processes, including intake assessment and standard PMO reporting

• Facilitate RFP initiatives for evaluating new technology solutions

• Perform vendor management activities such as establishing contracts (e.g., NDA, MSA, SOW) and managing ongoing licensing and renewals

• Create training materials, "How To," and knowledge items to ease user adoption of new technology

• Define standard operating procedures and perform periodic review activities for R&D systems

• Facilitate UAT with business partners

• Define, coordinate and/or execute system integration testing as needed

• Triage and facilitate resolution of application issues and escalate to vendor support as needed

• Conduct source systems data quality analysis as needed

• Perform computer systems validation activities adhering to 21 CFR Part 11 guidelines

• Provide configuration support for key ( systems, if required

Education/Experience/Skills:

Bachelor's degree in Information Systems or equivalent technical discipline. A minimum of 8 years of progressively responsible experience in the pharmaceutical industry with a focus on R&D, Quality, and Manufacturing systems and processes, as well as computer system validation. An equivalent combination of relevant education and applicable job experience may be considered.

Must possess:

• Experience working in a regulated environment following GxP processes

• Solid domain knowledge of business processes and related data types in functional areas (Pre-clinical, clinical development, clinical operations, regulatory, pharmacovigilance, biostatistics, data management, quality, and manufacturing), to support technology solutions

• Ability to be highly organized, self-motivated with the capability to prioritize projects and workload

• Skilled at effectively leading IT projects with cross-functional team effort and organizing resources to achieve project goals

• Adaptability to quickly and proactively implement change initiatives

• Excellent attention to detail

• Excellent interpersonal and communication skills, including tact, diplomacy, and flexibility

• Excellent skills in defining and documenting processes, requirements, and training materials

• Experience documenting SOPs and other controlled documents

• Experience with change management and computer systems validation processes

• Experience with operational systems support for key systems providing issue resolution through internal resources and vendor support

• Experience with standard systems development life cycle (SDLC) and SaaS deployment models

• Familiarity with EDC, IRT, eTMF, CTMS, SAS, Argus, clinical analytics, safety, LMS, QMS, TraceLink, Veeva Vault and/or regulatory systems

The following considered a plus:

• Familiarity with global GCP, GVP, GMP. and GLP regulations

• Experience in clinical, manufacturing, quality, and regulatory systems

• Experience supporting clinical trials in an outsourced model (working with CROs, FSPs, CSPs)

• PMP certification

Physical Requirements:

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment. Employee must occasionally lift and/or move up to 15 pounds.

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