Study Start-Up Specialist

3 days ago


Kuala Lumpur, Kuala Lumpur, Malaysia IQVIA Argentina Full time
Job Description

The Study Start-Up Specialist will be responsible for directing and managing the delivery of site activation, maintenance, and regulatory activities for selected studies or multi-protocol programs. This includes 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.

The ideal candidate will 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. They 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.

Required Skills and Qualifications

• Strong knowledge of clinical trials regulations and guidelines

• Excellent project management skills

• Ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects

• Good regulatory and technical writing skills

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.

Others

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries.



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