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Job Overview

Leads and oversees the execution of clinical projects and research studies in accordance with global and local regulations to best meet customer needs while working toward organizational goals and strategies.

Manages the operational elements of clinical projects to deliver contracted clinical services to the customer’s satisfaction. Develops and maintains clinical project plans; accountable for subject recruitment, site management, and data integrity; and ensuring that appropriate recruitment strategies are in place.

Essential Functions:

• Registration on clinicaltrials.gov
• TMF Management Plan
• Perform Functional checks and eTMF maintenance for study
• Activate sites in GILDA
• Preparing, handling, distributing, filing, and archiving of clinical documentation and reports as per the scope of work and standard operating procedures.
• Assist the Study lead  in providing a periodic review of the prospective principal investigators to be selected for participation in the study.
• To ensure that the CRA transition documentation is complete.
• Assist with periodic review of study files for accuracy and completeness.
• Perform close out activities for study in close out phase. Perform administrative tasks to support team members with clinical trial execution as needed.
• Assist the Quality Team with Monthly Investigator Quality reviews, mitigation strategy calls and preparation of Meeting minute

The Study Process Lead is a member of the core project team responsible for clinical delivery of clinical studies to meet contractual requirements in accordance with Standard Operating Procedures (SOPs), policies and practices. Clinical Leads partner with Project Leaders and other functional teams to secure delivery requirements are met at all times.

Study Process Leads ensure clinical delivery to customers, lead clinical teams and partner with Project Leaders and other functional teams ensuring projects meet delivery requirements at all times.

Qualifications

• Bachelor's Degree Life sciences or related field Req
• 3-5 years of relevant experience.
• Good knowledge of, and skill in applying applicable clinical research regulatory requirements; i.e., ICH GCP and relevant local laws, regulations and guidelines
• Advanced English level
• Strong written and verbal communication skills
• Results and detail-oriented approach to work delivery and output
• Good problem solving, time management and prioritization skills
• Proven ability to work on multiple projects balancing competing priorities
• Good leadership skills
• Ability to work across cultures and geographies with a high awareness and understanding of  cultural differences

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 to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com