Clinical Operations

• Accountable for and provides management support and direct supervision to Clinical Operations staff in the assigned areas including Site Selection support, site contracts support, regulatory/ethics submissions, site activities including site activation as well as On-Site Monitoring and/or Central Monitoring through Study Close Out.
• Provides training, consultation and oversees metric compliance and quality related to operating activities of assigned staff to ensure project deliverables are met.
• Collaborates and oversees Clinical Operations Team to ensure fulfillment of customer requirements and compliance with related regulations.
• Supports senior management in operational level planning.
• May participate in business development presentations as a subject matter expert in Clinical Operations functions within the Company.
• Line management of Clinical Operations staff, responsibilities including interviewing and selection, termination, professional development, performance appraisals, and employee counselling. May be involved in assignment of project work and will review workloads for all direct reports.
• Manages staff by establishing goals that will increase knowledge and skill levels, and by delegating tasks commensurate with skill level.
• Review workload for all staff in reporting chain, participate in managing the resource availability for the assigned staff, providing support that projects are suitably resourced and staffing needs are identified in a timely fashion.
• Provide expert operational oversight and guidance to support prioritization of activities, review and monitor the work performed, metric compliance, and development of contingency plans, among others.
• Assist in recruiting new staff, including participation in interview process and new hire on boarding. Proactively work to ensure staff retention and turnover rates remain within expected levels.
• Ensure quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WIs) and compliance with federal and local guidelines and ICH GCP. Ensure all staff follow required training and complete required documentation. Provide regular updates to management accordingly.
• Work closely within appropriate business unit/region to ensure staff performance on studies and correct deficiencies as identified by staff, customers, and auditors. Able to contribute to BU level process improvements. May provide business development support.
• May conduct several types of sign off and assessment visits to ensure Clinical Operations on-site performance. Develop and oversee training plans to address performance deficiencies. Ensure staff adhere to training guidelines, training records maintenance, and individual and corporate training needs are identified and addressed.
• Organize and chair clinical staff meetings at regular intervals. Manage issues and provide follow up for action items requiring resolution.
• Facilitate and support project and team/country reviews with Clinical Operations staff, focusing on budget, schedule, and risk analysis. Use department systems, reports, and dashboards to identify performance issues, process gaps and monitor overall performance progress in line with departmental goals and metric targets. Oversee all quality control efforts of assigned teams.

Manager, Clinical Operations

• Supports the Product Owner and squad by collecting requirements, documenting processes, and helping translate business needs into actionable backlog items.
• Partner with Clinical Operations stakeholders and the Product Owner to understand user needs and translate business needs into clear business and functional requirements for digital solutions.
• Build and maintain user stories, acceptance criteria, use cases, visualizations, process flows, and supporting documentation for the squad backlog.
• Support backlog refinement and stay ahead of sprint execution by helping ensure features are clearly defined, aligned to business priorities, and ready to enter development.
• Work with developers, testers, and business stakeholders to clarify requirements, explain functional intent, and support a strong user experience for clinical operations users.
• Assist with user acceptance testing by helping define test scenarios, documenting encouraged results, coordinating feedback, and tracking outcomes to support high-quality releases.
• Document confirmed business processes to serve as reference for development, support, harmonization, and continuous improvement.
• Track team, product, or process metrics and prepare reports that help stakeholders measure progress, adoption, and improvement opportunities.
• Collaborate with peer analysts, Product Owners, and cross-functional teams to manage dependencies, communicate impacts, and support aligned delivery across squads or related teams.
• Apply compliance requirements within scope of responsibility and help ensure SDLC documentation, system-related documentation, and required quality activities remain current.

Clinical Operations jobs in India

See all jobs on JobTailor

Manager, Clinical Operations

Technical Product Analyst, Clinical Operations