Associate Director, Digital Clinical Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Improve productivity within Global Clinical Operations and decrease inefficiencies in clinical trials.

• Specify enhancements for CTMS and other digital solutions throughout the phases of clinical trial planning, initiation, management, and closure.

• Collaborate with clinical stakeholders across various locations and functions to identify CTMS enhancement requirements.

• Gather and document requirements while ensuring alignment with organizational, regional, and process standards.

• Prioritize requests, manage conflicting interests, communicate priorities, and transform them into actionable development plans.

• Compose and finalize business requirements and user stories.

• Coordinate with Development and IT teams regarding sprint planning, testing, software development lifecycle (SDLC) testing, and user acceptance testing (UAT).

• Ensure alignment of CTMS and digital applications with GCO processes and create necessary process flows.

• Assist in the development of both short-term and long-term technology roadmaps.

• Define, monitor, and communicate value metrics for digital investments.

• Represent GCO business interests on implementation teams.

• Evaluate proposed designs for suitability and anticipated value.

• Manage the demand backlog and maintain user stories and their priorities.

• Oversee the champion network and facilitate communication between end users and product teams.

• Establish and maintain a SharePoint website for communication with end-users and champions.

• Analyze technology and industry trends to uncover innovative opportunities.

• Monitor, assess, optimize, troubleshoot, and resolve issues related to technology solutions.

• Manage project progress, timelines, responsibilities, risks, and budgets.

• Collaborate with Development Data Science, QA, IT, Clinical Operations, Data Management, and Supply Chain teams.

• Identify pain points and manual workflows, and create technological solutions.

• Plan and execute communication, training, user communities, and adoption initiatives.

• Supervise consultants or analysts on a matrixed team as necessary.

⛳️ Requirements

• Bachelor’s or Master’s degree in computer science or a related field.

• Over 8 years of experience in drug development clinical trial operations.

• Expertise in Clinical Operations domain.

• Experience in business analysis for technology projects.

• Knowledge of core clinical systems.

• Familiarity with SDLC.

• Understanding of validated systems.

• Experience in requirement gathering and documentation.

• Proficiency in process modeling.

• Familiarity with clinical operations applications like CTMS.

• Knowledge of data processing/engineering is advantageous.

• Excellent stakeholder management and communication skills.

• Awareness of cross-cultural dynamics.

• Ability to collaborate across functions.

• Strong conceptual, analytical, problem-solving, and troubleshooting abilities.

🏝️ Benefits

• Eligibility for an annual bonus plan for non-commercial roles.

• Incentive compensation plan eligibility for commercial roles.

• Discretionary equity awards.

• Employee Stock Purchase Plan.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) plan.

• Flexible Spending Account/Health Savings Account.

• Life insurance.

• Paid Time Off.

• Wellness benefits.

• Travel as required.