
SALVAVIDAS PHARMACEUTICAL
Urgently Required
Clinical Research Manager
Experience : 1 to 5 years
No of vacancies : 1
Job Description: The Clinical Research Manager plays a pivotal role in managing the operations of clinical research projects within healthcare settings. This individual is responsible for overseeing the planning, implementation, and completion of clinical trials, ensuring compliance with regulatory standards, and maintaining the integrity and quality of research data. The role involves coordinating with multiple stakeholders, including clinicians, researchers, and regulatory bodies, to facilitate the smooth execution of clinical studies aimed at advancing medical knowledge and patient care.
Key Responsibilities: Project Management: Oversee the planning, execution, and completion of clinical trials, ensuring projects are delivered on time, within budget, and in accordance with scientific and ethical standards.
Regulatory Compliance: Ensure all clinical research activities comply with institutional policies, as well as local, national, and international regulatory requirements, including IRB approvals and patient consent.
Team Coordination: Lead and manage a multidisciplinary team of clinical research coordinators, data managers, and other support staff, facilitating effective communication and collaboration.
Participant Management: Oversee patient recruitment, enrollment, and follow-up, ensuring participant safety and adherence to study protocols.
Data Management and Analysis: Supervise the collection, management, and analysis of research data, ensuring accuracy and integrity. Collaborate with statisticians and data analysts to interpret results.
Budget and Resources: Develop and manage study budgets, negotiate contracts with vendors and sponsors, and oversee resource allocation to ensure efficient use of funds and equipment.
Quality Assurance: Implement quality control processes throughout the lifecycle of clinical trials to ensure compliance with protocols and standards.
Stakeholder Communication: Serve as the primary point of contact for all stakeholders, including sponsors, regulatory bodies, and institutional leadership, providing regular updates on research progress and outcomes.
Education Qualifications: Education: Bachelor’s degree in a life sciences or healthcare-related field; a master’s degree or higher is often preferred.
Experience: Significant experience in clinical research, including roles with increasing responsibility in clinical trial management.
Skills: Strong project management, leadership, and communication skills; thorough understanding of regulatory requirements and ethical guidelines in clinical research; proficiency in data management and analysis tools.
Certifications/Licenses: Certification as a Clinical Research Coordinator (CRC) or Clinical Research Associate (CRA) is highly beneficial.
Key Attributes: Analytical and Detail-Oriented: Ability to meticulously plan and execute clinical trials, paying close attention to details and data integrity.
Leadership and Teamwork: Strong leadership qualities to manage and motivate a diverse team, fostering a collaborative and productive work environment.
Ethical Judgment: A commitment to upholding the highest ethical standards in all research activities, ensuring the safety and dignity of study participants.
Adaptability: Flexibility to handle the dynamic challenges of clinical research, including changes in regulatory standards, project scopes, and participant needs.
Problem-Solving Skills: Capable of identifying and resolving issues that arise during the research process, ensuring the continuity and success of clinical trials.
About the Role: Advocate for Innovation: By managing clinical trials, the Clinical Research Manager contributes to the development of new treatments, therapies, and medical devices, driving innovation in healthcare.
Quality and Safety Promoter: Ensures that clinical research adheres to the highest quality standards and regulatory requirements, promoting patient safety and the validity of research outcomes.
Educator and Mentor: Provides training and guidance to clinical research staff, contributing to the professional development of team members and fostering a culture of excellence in research.
Communicator and Liaison: Acts as a key liaison between the research team, study sponsors, and regulatory authorities, facilitating communication and collaboration across the healthcare ecosystem.
The Clinical Research Manager is essential for ensuring that clinical trials are conducted efficiently, ethically, and in compliance with all regulatory standards, thereby contributing significantly to advances in medical research and patient care.