Manager, Clinical Operations

Jobtailor; Hyderabad; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Jobtailor in Hyderabad, India seeks an experienced Clinical Operations Manager to lead and supervise the Clinical Operations staff across sites. You will oversee site selection support, regulatory submissions, and on‑site monitoring through study close‑out, ensuring quality and compliance with ICH GCP guidelines.

You will train and mentor teams, manage budgets and resources, and collaborate with senior management on operational planning. Travel up to 25% is required as projects demand it.

Qualifications

• Bachelor's degree plus extensive clinical research experience in CRO/pharma/biotech.
• Leadership experience overseeing teams of 15–16 direct reports.
• Strong knowledge of GCP/ICH guidelines and regulatory requirements.
• Excellent written and spoken communication and change-management skills.
• Ability to travel up to 25%.

Responsibilities

• Accountable for and provides management support to Clinical Operations staff in assigned areas including site selection support, site contract support, regulatory/ethics submissions, site activities and monitoring.
• Provides training, consultation, and oversees metric compliance and quality related to operating activities to ensure project deliverables are met.
• Collaborates with Clinical Operations Team to ensure customer requirements and regulatory compliance are fulfilled.
• Supports senior management in operational level planning.
• May participate in business development presentations as a SME in Clinical Operations within the company.
• Line-manages Clinical Operations staff including interviewing, selection, performance appraisals, and workload review.
• Manages staff with goal setting and delegation aligned to skills; reviews resource availability and staffing needs.
• Provides expert oversight to prioritize activities, monitor performance, and develop contingency plans.
• Assists in recruiting new staff and onboarding; works to retain staff and manage turnover.
• Ensures adherence to SOPs/WIs and compliance with federal/local guidelines and ICH GCP; tracks training and documentation.
• Collaborates with business units to ensure staff performance on studies and drives process improvements.
• May conduct sign-off and assessment visits to ensure on-site performance and develops training plans.
• Organizes and chairs clinical staff meetings and follows up on action items.
• Facilitates project and team reviews focusing on budget, schedule, and risk analysis; uses dashboards to identify issues and monitor progress.

Skills

People management

Regulatory expertise

GCP/ICH knowledge

Leadership

Communication skills

Education

Bachelor's degree in life sciences, nursing or equivalent

Job description

Responsibilities

• Accountable for and provides management support and direct supervision to Clinical Operations staff in the assigned areas including site selection support, site contract 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‑manages Clinical Operations staff, including interviewing and selection, termination, professional development, performance appraisals, and employee counselling; may be involved in assignment of project work and review workloads for all direct reports.
• Manages staff by establishing goals that increase knowledge and skill levels, and by delegating tasks commensurate with skill level.
• Reviews workload for all staff in the reporting chain, participates in managing resource availability, and ensures projects are suitably resourced with timely staffing needs identified.
• Provides expert operational oversight and guidance to support prioritization of activities, reviews and monitors work performed, ensures metric compliance, and develops contingency plans.
• Assists in recruiting new staff, participates in interview process, and onboarding of new hires; proactively works to ensure staff retention and turnover rates remain within expected levels.
• Ensures quality and adherence to SOP/WIs and compliance with federal and local guidelines and ICH GCP; ensures all staff complete required training and documentation and provides regular updates to management.
• Works closely within the appropriate business unit/region to ensure staff performance on studies and correct deficiencies as identified by staff, customers, and auditors; contributes to BU‑level process improvements and may provide business development support.
• May conduct several types of sign‑off and assessment visits to ensure clinical operations on‑site performance; develops and oversees training plans to address performance deficiencies and ensures staff adhere to training guidelines, record maintenance, and individual and corporate training needs.
• Organizes and chairs clinical staff meetings at regular intervals; manages issues and follows up for action items requiring resolution.
• Facilitates and supports project and team/country reviews with Clinical Operations staff, focusing on budget, schedule, and risk analysis; uses department systems, reports, and dashboards to identify performance issues, process gaps, and monitors overall performance progress in line with departmental goals and metric targets; oversees all quality control efforts of assigned teams.

Requirements

• Bachelor’s degree in life sciences, nursing degree, or equivalent related experience, plus extensive clinical research experience in a contract research organization, pharmaceutical, or biotechnology company, including some time in a leadership capacity or equivalent combination of education, training and experience is required.
• Preference for experience in the industry, managing clinical portfolios, and in clinical operations.
• Strong experience in Regulatory & Startup process.
• People management experience in managing 15–16 direct reports.
• Extensive knowledge of GCP/ICH guidelines and other applicable regulatory requirements.
• Excellent communication, presentation, interpersonal, and change‑management skills, both written and spoken, with an 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 as related to forecasting and budgeting. Understands project budgets.
• Must demonstrate good computer skills and be able to embrace modern technologies.
• Ability to travel as necessary (up to 25%).