Clinical Operations Manager (Karnataka)

Clinical Operations Manager (Karnataka)

31 Jul
|
MS CLINICAL RESEARCH
|
Karnataka

31 Jul

MS CLINICAL RESEARCH

Karnataka

Job DescriptionJob Summary NThe 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. NKey Responsibilitiesn1. Departmental Study Management Nn Lead the planningand execution of clinical studies across multiple domains (Skin, Hair, Oral). N Ensure studies are conducted in alignment with organizational goals, timelines, and budgets. N Oversee day-to-day operations of the Clinical Operations team. Nn2. Study Planning & Execution Nn Develop study plans, timelines, and resource allocation strategies. N Ensure all study activities are executed as per protocol schedules and client expectations. N Review study documents including protocols, CRFs, questionnaires, and monitoring plans. N Identify operational risks and implement mitigation strategies. Nn3. Site & Investigator Management Nn Conduct Site Initiation Visits (SIVs), monitoring visits, and close-out activities as per plan. N Ensure proper study delegation of responsibilities and oversight at all sites. N Maintain robust relationships with investigators and site personnel to ensure smooth project execution. Nn4. Training & Compliance Nn Oversee and ensure completion of protocol, SOP, and GCP training for internal teams and site staff.



N Monitor adherence to regulatory requirements and internal quality standards. N Ensure thorough documentation of training and compliance activities. Nn5. Sponsor & Multisite Coordination Nn Act as the primary point of contact for all study-related communication with sponsors. N Coordinate multisite studies, ensuring consistency in execution, data quality, and reporting. N Facilitate project updates, timelines, and deliverables with cross-functional teams and clients. Nn6. Quality & Documentation Nn Ensure timely completion of study documentation, including monitoring reports, study logs, and regulatory files. N Oversee audit readinessand support internal/external audits. N Drive continuous improvement in clinical operational processes. NnKey Skills & Competencies Nn Strong knowledge of clinical research processes, GCP, and regulatory guidelines. N Expertise in managing Skin, Hair, Cosmetic, or Dermatology-based clinical studies (preferred). N Excellent communicationand stakeholder management skills. N Ability to lead teams and manage multiple projects simultaneously. N Strong analytical thinking, documentation, and problem-solving skills. NnQualificationsn N Master's/Bachelor's degree in Life Sciences, Pharmacy, Cosmetic Technology, or related field. N 5–10 years of experience in clinical trials, with at least 2–3 years in a supervisory/managerial role. N Experience in cosmetic/dermatology clinical studies is highly desirable. NnReporting Ton N Director–Business Operations N

📌 Clinical Operations Manager (Karnataka)
🏢 MS CLINICAL RESEARCH
📍 Karnataka

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