Leader - Clinical Research Operations

NovoBliss Research®️ Private Limited; Ahmedabad District; Sur place; INR 1 500 000 - 2 500 000; Plein temps

Résumé du poste

NovoBliss Research®️ Private Limited in Ahmedabad is seeking a Leader – Clinical Research Operations to oversee end-to-end planning, execution, and delivery of clinical studies on-site. You will manage study timelines, resources, and budgets while coordinating clinical, data management, and QA teams.

You will develop SOPs, supervise site initiation, support regulatory submissions and audits, mentor staff, and drive continuous process improvement, maintaining strong relationships with

Qualifications

• Strong clinical research operations expertise, including study planning, site management, monitoring, and multicenter coordination.
• Regulatory and quality compliance knowledge, including GCP/ICH guidelines, SOPs, and audit readiness.
• Experience in project and team leadership, covering resource allocation, timelines, cross-functional collaboration, and mentoring.
• Proficiency in data management and documentation practices, including CRF review and data integrity oversight.
• Excellent communication and stakeholder management skills with investigators, sponsors, and regulatory bodies.
• Prior CRO or clinical research experience, preferably in consumer healthcare or pharmaceutical studies.
• Strong analytical, problem-solving, and decision-making abilities focused on efficiency and improvement.

Responsabilités

• Oversee end-to-end planning, execution, and delivery of clinical studies, ensuring regulatory compliance.
• Manage study timelines, resources, and budgets, coordinating cross-functional teams (clinical, data management, QA).
• Develop and implement SOPs; supervise site selection, initiation, and monitoring to address operational challenges.
• Review study protocols and regulatory submissions; support audits and sponsor communications.
• Mentor team members and drive continuous process improvement while maintaining relationships with investigators and stakeholders.

Connaissances

Clinical operations

Regulatory compliance

Project leadership

Data management

Stakeholder management

GCP/ICH familiarity

Team mentoring

CRO experience

Formation

Master’s or bachelor’s degree in life sciences or related field

Description du poste

Company Description

NovoBliss Research®, based in Ahmedabad, India, is a CDSCO-registered and ISO 9001:2015 certified Contract Research Organization specializing in clinically validated safety and efficacy studies for consumer healthcare products. The organization works across multiple sectors, including nutraceuticals, pharmaceuticals, cosmetics, dental, OTC, and personal healthcare products. As a member of the Advertising Standards Council of India (ASCI) and the Indian Society for Clinical Research (ISCR), NovoBliss Research® maintains strong ethical and regulatory standards. The company is committed to advancing global clinical research through scientific excellence, innovation, and integrity. Its approach emphasizes robust study design, streamlined data collection, and rigorous analysis to deliver precise, high-quality research outcomes.

Role Description

The Leader – Clinical Research Operations will oversee end-to-end planning, execution, and delivery of clinical studies, ensuring adherence to regulatory requirements and internal quality standards. This full-time, on-site role in Ahmedabad involves managing study timelines, resources, and budgets, as well as coordinating cross-functional teams including clinical, data management, and quality assurance. The role includes developing and implementing standard operating procedures, supervising site selection and initiation, and monitoring study progress to address operational challenges proactively. The leader will review study protocols, operational plans, and documentation, and support regulatory submissions and audits. They will also mentor team members, foster continuous process improvement, and maintain strong relationships with investigators, sponsors, and other external stakeholders.

Qualifications

• Strong clinical research operations expertise, including study planning, site management, monitoring, and coordination of multicenter trials.
• Demonstrated ability in regulatory and quality compliance, including GCP, ICH guidelines, SOP development, and audit readiness.
• Experience in project and team leadership, covering resource allocation, timeline management, cross-functional collaboration, and performance mentoring.
• Proficiency in data management and documentation practices, including CRF review, data integrity oversight, and report preparation.
• Excellent communication and stakeholder management skills, with the ability to work effectively with investigators, sponsors, and regulatory bodies.
• Master’s or bachelor’s degree in life sciences, pharmacy, medicine, or a related field; advanced qualifications in clinical research are an advantage.
• Prior experience in a CRO or clinical research setting, preferably in consumer healthcare, nutraceuticals, or pharmaceutical studies.
• Strong analytical, problem-solving, and decision-making abilities, with a focus on operational efficiency and continuous improvement.