Associate Director, Clinical Operations Enablement & Knowledge Systems
Behavioral Health Market Context
Apply Nowvia Ladders
Qualifications
- •The ideal candidate is a Clinical Operations leader who combines deep study execution experience with the ability to design scalable, user-centered systems that enable others to perform at their best
- •Track adoption, effectiveness and impact of learning and knowledge initiatives
- •RN or Bachelor's degree in biological sciences or health-related field required
- •11+ years direct Clinical Operations experience in the pharmaceutical or biotech industry, Relevant indirect experiences may also meet the requirement
- •Minimum of 5 years of line management experience
- •Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP
- •Demonstrated experience successfully developing and authoring Clinical Operations and cross-functional handbooks, guidances or process templates in support of clinical operations or clinical study team management
- •Experience with leading organizational change efforts
- •Minimum of 6 years of cross-functional study management or related leadership experience in life sciences
- •Demonstrated experience building or scaling learning programs, knowledge systems, or operational frameworks within Clinical Operations
- •Experience translating complex clinical workflows into practical tools, guidance, or training materials
- •Strong systems thinking and ability to design scalable, user-friendly solutions
- •Experience in selection and management of external resources (e.g., CROs, vendors, contractors)
- •Thrives in a collaborative team setting that demonstrates flexibility required to maintain a fast pace and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment
- •Be solution-oriented by anticipating obstacles and difficulties, and proactively providing risk assessment and mitigation strategies to achieve project goals
- •Ability to deal with time demands, incomplete information, or unexpected events
- •Outstanding organizational skills with the ability to multi-task and prioritize
- •Excellent interpersonal, verbal and written communication skills
- •High sense of priority and commitment to excellence in the successful execution of deliverables
- •Ability to contribute with a mind on quality, diligence, timeliness and fiscal responsibility, make and drive decisions, multi-task, prioritize tasks, anticipate challenges, and execute on goals as a member of the Clinical Operations Excellence team
- •Decision-making skills
- •Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities
- •Travel may be required (~25%)
- •20 more items(s)
Responsibilities
- •As an Associate Director (AD) Clinical Operations Enablement & Knowledge Systems, you will be a key member of the Clinical Operations Excellence team
- •You will be responsible for building and scaling the Clinical Operations "knowledge ecosystem"-including how information is structured, accessed, and applied-to enable consistent, efficient, and high-quality study execution across roles and programs
- •This is an execution-focused role that strengthens the capabilities of the Clinical Operations organization
- •Lead the design and deployment of a scalable Clinical Operations knowledge ecosystem, including playbooks, toolkits and structured resources that enable consistent high quality study execution
- •Develop role-based enablement frameworks aligned to Clinical Operations responsibilities, study activities, and key transition points
- •Design and deliver multi-modal learning solutions (e.g., live sessions, on-demand modules, short-form videos, playbooks, and interactive resources) to maximize accessibility and adoption
- •Apply adult learning principles and user-centered design to ensure content is practical, engaging, and immediately applicable
- •Apply knowledge of Clinical Operations workflows and regulatory context (e.g., GCP, ICH) to ensure learning content is relevant, practical, and aligned with real-world study execution (this role does not own SOP development, GxP training, or inspection readiness activities)
- •Support the successful onboarding of new Clinical Operations team members
- •Design and deliver targeted, "just-in-time" learning tools and experiences (e.g., checklists, quick guides, decision aids) to support critical activities and study milestones
- •Align learning and knowledge resources to key study lifecycle stages (e.g., study start-up, conduct, database lock, close-out)
- •Define and implement a scalable structure for Clinical Operations knowledge, including how resources, tools, and guidance is organized, accessed, and maintained
- •Create intuitive, role-based pathways for accessing information across study lifecycle stages
- •Establish standards for maintaining and continuously improving operational knowledge
- •Own day-to-day planning, coordination, and delivery of learning activities, ensuring timeline, quality and outcomes are met
- •Use feedback and performance insights to identify capability gaps and continuously improve tools, resources, and learning solutions
- •Evolve learning materials and resources to maintain alignment with Clinical Operations and cross-functional partner growth and needs
- •Partner with Clinical Operations and cross-functional team members to improve processes that will impact clinical trial management, quality and efficiency
- •Line management responsibilities including hiring, performance management, career development, and mentorship
- •This role does not own SOP authoring, GxP training delivery, or inspection readiness activities, but partners with relevant functions to ensure alignment
- •Participate in other Clinical Operations Excellence and Clinical Operations Activities as appropriate
- •18 more items(s)
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