Clinical Research Operations Lead

1 day ago


Kuala Lumpur, Kuala Lumpur, Malaysia IQVIA Argentina Full time
Key Responsibilities

As a Clinical Research Operations Lead at IQVIA, you will be responsible for directing and managing the delivery of site activation, maintenance, and regulatory activities for selected studies or multi-protocol programs. Your key responsibilities will include overseeing the execution of site activation, developing and implementing management plans, ensuring collaboration across regulatory and site activation teams, creating technical and administrative documentation, providing specialist regulatory and technical scientific support, and determining regulatory strategy and expectations.

You will also be responsible for assessing and reviewing the regulatory landscape, contributing to the collection and dissemination of accurate regulatory intelligence, executing operational strategy and expectations for maintenance of clinical study approvals, and mentoring and coaching colleagues as required.

In addition, you may take a lead role in developing long-standing relationships with preferred customers, deliver presentations and training to clients and colleagues, and be involved in monthly study budget planning and reviews.

Required Skills and Qualifications

To be successful in this role, you will need to have a Bachelor's degree in a life science or related field, with 3-5 years of regional experience in a clinical research environment, ideally in regulatory and study start-up capacity. You will also need strong negotiation and communication skills, excellent interpersonal skills, and the ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects.

You will also need a thorough understanding of the regulated clinical trial environment, in-depth knowledge of drug development processes, demonstrated proficiency in using systems and technology to achieve work objectives, good regulatory and technical writing skills, and strong knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines.

Benefits

IQVIA offers a range of benefits to its employees, including opportunities for professional growth and development, a collaborative and dynamic work environment, and a competitive compensation package.

As a Clinical Research Operations Lead at IQVIA, you will have the opportunity to work on exciting and challenging projects, develop your skills and expertise, and contribute to the success of our business.

Others

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments, improving patient outcomes and population health worldwide.



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