Senior Director Data Management

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.

The Sr. Director is a key leadership role in the R&D organization. This individual will provide strategic direction, leadership and management in shaping operational excellence within the Data Management (DM) team. Directs the design, documentation, testing and implementation of clinical data collection studies, and clinical database reviews in support of company objectives. The Sr. Director will work with leadership across Acadia's functional areas on the continuous development and improvement of business processes to support Data Management. Ensures that the data management systems are business ready and of appropriate quality to fulfill those objectives. Leads outsourcing of data management and management of vendor/FSP alliance.

Primary Responsibilities

• Provide strategic leadership of data management function

• Development of department standards and procedures (e.g., SOPs, job aids)

• Identification and leadership of critical DM process improvement initiatives

• Development and management of department budget, resourcing and contracts

• Identification, evaluation and selection of DM vendors

• Lead vendor qualification and oversight audits as DM SME

• Establishment and management of key vendor partnerships

• Ensure department compliance with regulatory and industry process and quality standards

• Ensure program compliance with regulatory and industry process and quality standards, including representation of function in regulatory inspections

• Proactively identifies potential study or process issues/risks and spearheads solutions

• Reviews/approves study-related documents (e.g., eCRF and edit check requirements, Clinical Data Management Plan, CRF Completion Guidelines), as applicable

• Direct report management and mentorship, as applicable

• Participates in the selection, training and evaluation of DM personnel (internal and contract) to ensure efficient and effective department function

• Ensures that Clinical Data Management interfaces effectively with other Departments.

• Anticipates new challenges, risks, and needs for Data Management, and proactively mitigates to ensure business continuity and quality

• Identifies and resolved quality issues and mitigates future risk

• Responsible for ensuring data management timelines are met

• Provides strategic input into protocol design focused on data management issues

• Develops standards and process documentation, including SOPs and Work Instructions

Education/Experience/Skills

Bachelor's degree in the scientific, biological, statistical or computer science field or related discipline; advanced degree strongly preferred. Targeting 12-15 years of experience in the pharma/biotech industry, including 10 years direct report or vendor management experience. An equivalent combination of relevant education and experience may be considered.

Key Skills:

• Vendor evaluation, selection and management experience

• Experience in managing multiple direct reports, contingent workers and programs

• Experienced in resource planning

• Self-directed, technically strong, and a recognized leader maintaining a strategic prospective regarding data management processes, management of DM activities and customer management

• Experience managing data management activities outsourced to Clinical Research Organizations, Functional Service Providers, and other vendors

• Knowledge of lab/image data and other external data sources

• Strong understanding of clinical trials, pharmaceutical operations, and regulatory compliance

• Practical knowledge of FDA regulations/ICH guidelines, as related to data integrity

• Ability to manage time demands, incomplete information and unexpected events

• Ability to build and maintain positive relationships with management, peers, and direct reports

• Excellent communication and interpersonal skills

• Strong analytical and problem-solving skills. Attention to detail.

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 and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. Ability to travel independently overnight and work after hours if required by travel schedule or business needs

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