Central Monitor (India/China)

About The Role:

The Central Monitor is primarily responsible for high quality risk-based monitoring analytics supporting an approach to clinical trial monitoring which utilizes patient data and site/country/project level information to determine needs for performing on-site, remote and centralized activities and focuses resources on potential risks that impact to data quality and patient safety.

Minimum Qualifications & Experience:

Education:

• Minimum bachelor’s degree with concentration in Clinical, Life Sciences, Mathematics, Statistics, or related field.

Knowledge, Skills, And Abilities:

• Good GCP knowledge, good clinical trial related knowledge, experience in clinical study.
• Ability to identify risk and trends. Data analysis and technical skills in clinical trials/clinical data are preferred.
• Good interpersonal skills allowing professional communication with all levels of the organizations.
• Can work independently as well as a good team player.
• Demonstrate the leadership in the cross-function work.
• Can be multitasked and can complete the work efficiently.

• Good Problem-Solving Capability.

• Fluent English both in written and oral.

Experiences:

• Experience in clinical trials with a minimum of 3 years or equivalent combination of education, training, and experience.

Responsibilities

• Planning the central monitoring in accordance with the SOP and GCP.
• Providing input into the Integrated Quality Risk Management Plan (IQRMP)
• Work with stakeholders for setup and activation of Central Monitoring system
• Conducting ongoing/periodic monitoring of patient data, site/country/project level data, quality etc. centrally using appropriate technology.
• Propose suggestions for signal and action management.
• Keeping track of action items and follow ups with relevant team members for closure of action items.
• Timely communicate with stakeholders for any significant non-compliance or other outstanding issues.
• Support in building overall efficiencies in clinical trial monitoring strategies by identifying risk trends to critical study processes and data.
• Responsible for documentation of centralized monitoring activities.
• Facilitating and attending central monitoring outcome review meetings with relevant stakeholders for tracking/controlling/solving of risk/issues.

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.
We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.
We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.

Novotech is a global full-service clinical Contract Research Organization (CRO).

Headquartered in Sydney, Australia, Novotech has 34 offices across Asia-Pacific, North America, and Europe. Novotech employs over 3000 employees and has over 5000 site partnerships and the resources and infrastructure to scale regionally and globally as clinical programs advance.

Novotech provides clinical development services across all clinical trial phases and therapeutic areas including feasibility assessments, ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management. Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies.