Director, Clinical Assessments - Neurology or Psychiatry

Cognitive Research Corporation

About The Position

The Director, Assessments provides leadership within the research and assessments team across Cognitive Research Corporation. Guides and supervises team members related to assessment, data analytics, and research. Assists with advancing assessment and data-driven decision making, and ensuring that assessment, data analytics, and research align with company objectives and effectively supports the clinical trial studies performed by CRC.

Requirements

MA/MS in Life Sciences, Statistics, computer science, or a related field, Doctoral degree preferred, or equivalent education, training and experience.
3 years plus experience working in pharmaceutical industry, biotechnology or CRO industry, or an equivalent combination of education and experience.
Experience providing rater training and prior hands on CNS therapeutic experience, specifially Alzheimer’s, MDD, Schizophrenia, GAD, Parkinson’s, etc...
Regulatory familarity and understanding with FDA and ICH guidelines regarding clinical end points, validation and data integrity
Understanding of and experience with psychological assessments.
Ability to work independently with minimal supervision.
Strong organizational skills.
Strong computer skills including but not limited to proficiency with Microsoft Office (Word, Outlook, and PowerPoint) and project management software (i.e.,Monday.com); advanced proficiency with Excel (e.g., creating and managing formulas; use of macros, pivot tables, and v-lookup; etc.).
Strong written and verbal communication skills; ability to communicate effectively with a wide variety of stakeholders in a professional manner via different means of communication (i.e., face to face, on the telephone, email, etc.).
Strong interpersonal skills with the ability to work with all levels of management and employees; ability to gain credibility, provide effective customer service, and foster positive working relationships with internal and external stakeholders
Excellent attention to detail, including problem solving and decision-making skills
Able to work accurately to identify, analyze, prevent, and solve issues
Able to collaborate closely and keep a running line of communication with other team members; ability to self-motivate with a strong work ethic
Unquestioned integrity and ethics with a confident but well-grounded approach to doing work.

Responsibilities

Reports directly to the Executive Director of Clinical Sciences, who provides oversight of the Assessments Department and must approve all final decisions, deliverables, and content developed and delivered to clients.
Oversees the coordination of Assessments operations and Sponsor project deliverables, in alignment with the direction and approvals of the Executive Director of Clinical Sciences.
Responsible for department quality delivery in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions, ensuring alignment with Executive Director expectations and final approvals.
Supervisory responsibilities include but are not limited to technical and operational guidance and direction, ensuring deliverables are met, timesheet approvals, and performance management, in collaboration with and under the oversight of the Executive Director of Clinical Sciences.
Ensures the department provides agreed upon deliverables while remaining within scope and allocated hours, escalating any scope, budget, or resource concerns to the Executive Director of Clinical Sciences as needed.
Assists Clinical Monitoring staff with site management activities, including serving as a project team liaison for sites on assigned studies, and communicating with sites as directed and/or approved by the Executive Director of Clinical Sciences when appropriate.
Serves as primary point of escalation for project teams and sponsors regarding Assessment-related issues, keeping the Executive Director of Clinical Sciences informed and engaged in resolution as appropriate.
Evaluates Assessment-related software and provides recommendations to the Executive Director of Clinical Sciences for input on selection and implementation.
Provides operational input into proposals, including participation in strategic Sponsor presentations; exhibits credibility and expertise in Business Development activities with existing and potential new Sponsors, in coordination with the Executive Director of Clinical Sciences.
Creates and assists with maintenance of Trial Master File (TMF) and project files, including participation in file audits. Prepares and maintains site manuals, reference tools and other documents.
Maintains, updates, and inputs clinical tracking information into relevant CRC systems, ensuring alignment with departmental standards approved by the Executive Director of Clinical Sciences.
Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client. Manages shared mailbox, processes site requests and routes correspondence appropriately, escalating matters to the Executive Director of Clinical Sciences as necessary.
Coordinates with Data Management and other cross functional departments with data received from electronic and non-electronic sources, ensuring alignment with departmental priorities and Executive Director guidance.
Coordinates the ordering of scales and testing materials.
Assists with coordination of team meetings, attends meetings and prepares agenda, meeting minutes, and action items, as appropriate.
Effectively collaborates with other CRC departments, administration and reports regularly to the Executive Leadership Team (ELT) and Senior Leadership Team (SLT), in partnership with the Executive Director of Clinical Sciences.
Assists in the analysis and interpretation of research data, in coordination with relevant stakeholders and under the oversight of the Executive Director of Clinical Sciences.
Provides oversight for all CRC psychometric offerings and services, in alignment with strategic direction set by the Executive Director of Clinical Sciences.
Authors and/or reviews Assessment-related Standard Operating Procedures (SOPs) and related controlled documents, with final approval from the Executive Director of Clinical Sciences prior to issuance or client use.
Perform other duties as assigned by the Executive Director of Clinical Sciences.