Clinical Operations Manager

MS Clinical Research; Bengaluru; On-site; INR 1,500,000 - 2,500,000; Full time

Job summary

MS Clinical Research in Bengaluru, India is seeking a Clinical Operations Manager to oversee clinical study execution in Skin, Hair, and Oral domains. The role involves managing operations, ensuring compliance with protocols, and coordinating with teams and sponsors.

The ideal candidate should possess a Master’s/Bachelor’s degree in relevant fields and 5-10+ years of experience in clinical trials, including supervisory roles. Strong skills in regulatory compliance and study management are essential.

Qualifications

• 5–10+ years of experience in clinical trials, with at least 2–3 years in a supervisory role.
• Expertise in managing Skin, Hair, Cosmetic, or Dermatology-based clinical studies.

Responsibilities

• Lead planning and execution of clinical studies across multiple domains.
• Ensure adherence to protocols, SOPs, and regulatory guidelines.
• Coordinate multisite studies ensuring consistency in execution.

Skills

Clinical study management

Regulatory compliance

Stakeholder management

Analytical thinking

Problem-solving

Education

Master’s/Bachelor’s degree in Life Sciences, Pharmacy, Cosmetic Technology

Job description

The Clinical Operations Manager will lead and oversee end-to-end clinical study execution across Skin, Hair, and Oral domains. This role is responsible for managing study operations, ensuring compliance with protocols, SOPs, and regulatory guidelines, and coordinating with internal teams, investigators, and sponsors. The candidate will ensure high-quality delivery of clinical projects within defined timelines and quality standards.

Key Responsibilities

1. Departmental Study Management

• Lead the planning and execution of clinical studies across multiple domains (Skin, Hair, Oral).
• Ensure studies are conducted in alignment with organizational goals, timelines, and budgets.
• Oversee day-to-day operations of the Clinical Operations team.

2. Study Planning & Execution

• Develop study plans, timelines, and resource allocation strategies.
• Ensure all study activities are executed as per protocol schedules and client expectations.
• Review study documents including protocols, CRFs, questionnaires, and monitoring plans.
• Identify operational risks and implement mitigation strategies.
• Conduct Site Initiation Visits (SIVs), monitoring visits, and close-out activities as per plan.
• Ensure proper study delegation of responsibilities and oversight at all sites.
• Maintain strong relationships with investigators and site personnel to ensure smooth project execution.

4. Training & Compliance

• Oversee and ensure completion of protocol, SOP, and GCP training for internal teams and site staff.
• Monitor adherence to regulatory requirements and internal quality standards.
• Ensure thorough documentation of training and compliance activities.

5. Sponsor & Multisite Coordination

• Act as the primary point of contact for all study-related communication with sponsors.
• Coordinate multisite studies, ensuring consistency in execution, data quality, and reporting.
• Facilitate project updates, timelines, and deliverables with cross-functional teams and clients.

6. Quality & Documentation

• Ensure timely completion of study documentation, including monitoring reports, study logs, and regulatory files.
• Oversee audit readiness and support internal/external audits.
• Drive continuous improvement in clinical operational processes.
• Strong knowledge of clinical research processes, GCP, and regulatory guidelines.
• Expertise in managing Skin, Hair, Cosmetic, or Dermatology-based clinical studies (preferred).
• Excellent communication and stakeholder management skills.
• Ability to lead teams and manage multiple projects simultaneously.
• Strong analytical thinking, documentation, and problem-solving skills.

Qualifications

• Master’s/Bachelor’s degree in Life Sciences, Pharmacy, Cosmetic Technology, or related field.
• 5–10+ years of experience in clinical trials, with at least 2–3 years in a supervisory/managerial role.
• Experience in cosmetic/dermatology clinical studies is highly desirable.