Manager, Clinical Operations

Overview

Manage and provide direct supervision to Clinical Operations staff across site selection, site contracts, regulatory/ethics submissions, site activation, monitoring and study close-out, while ensuring metric compliance, quality and customer requirements are met.

What you'll do

• Provide line management of Clinical Operations staff, including interviewing and selection, termination, professional development, performance appraisals and employee counselling.
• Review workloads for all staff in the reporting chain and manage resource availability so projects are suitably resourced.
• Set staff goals that increase knowledge and skill levels, and delegate tasks commensurate with skill level.
• Provide expert operational oversight, guidance and prioritization of activities, and monitor work performed, metric compliance and contingency plans.
• Assist in recruiting new staff, including participation in interviews and new hire onboarding, and proactively manage staff retention and turnover.
• Ensure quality and adherence to SOPs/Work Instructions and compliance with federal, local guidelines and ICH GCP; ensure staff complete required training and documentation.
• Work with the business unit/region to correct staff performance deficiencies identified by staff, customers and auditors, and contribute to BU-level process improvements.
• Develop and oversee training plans to address performance deficiencies, maintain training records and identify individual and corporate training needs.
• Organize and chair clinical staff meetings, manage issues and follow up on action items.
• Facilitate project and team/country reviews focusing on budget, schedule and risk analysis.
• Use department systems, reports and dashboards to identify performance issues and process gaps.
• Oversee all quality control efforts of assigned teams.
• Support senior management in operational-level planning, and may conduct sign-off and assessment visits and provide business development support as a subject matter expert.

What you'll need

• Bachelor's degree in life sciences or nursing, or equivalent related experience, plus extensive clinical research experience in a CRO, pharmaceutical or biotechnology company, including some time in a leadership capacity; or an equivalent combination of education, training and experience.
• Minimum 10 years of experience.
• Minimum 1+ year of people management/line management experience.
• Extensive knowledge of GCP/ICH guidelines and other applicable regulatory requirements.
• Excellent written and spoken communication, presentation, interpersonal and change management skills, with the ability to inform, influence, convince and persuade.
• Strong time management, technical and organizational skills.
• Ability to work independently and within a team environment.
• Knowledge of basic financial concepts related to forecasting and budgeting, and understanding of project budgets.
• Good computer skills and ability to embrace modern technologies.
• Ability to travel as necessary (up to 25%).

Nice to have

• Experience in Clinical Research, Clinical Operations or Clinical Project Management.

Details

• Location: Hyderabad, India.
• Work mode: Hybrid.
• Travel: up to 25% as necessary.