- Location
- Bangalore, India
- Department
- Healthcare
- Seniority
- Manager
- Experience
- 5+ years
- Source
- Keka
Description
About the job
Job Summary
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.
3. Site & Investigator Management
- 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.
Key Skills & Competencies
- 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.
Reporting To
- Director–Business Operations
Skills
GCPClinical TrialsCompliance