Study Process Lead

Location: Mexico City Mexico

Hybrid role

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 customers 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

• 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

• Minimum 4-5 years of experience in the clinical trial industry (previous CRO employment).

• Excellent command of English language.

• Excellent command of Microsoft Office.

• Advanced knowledge of Project Management principles Planning Resourcing Execution Oversight Risk Management (completed Project Management Fundamentals course is preferred Advanced is a plus).

• At least 3 years of experience with Clinical Trial Management systems (CTMS) and/or Veeva Vault eTMF and/or EDC (Medidata).

• Preferably with previous client facing roles in Project Management / TMF Management / Clinical Operations Management / Site Management / Site Activation Management / Real World Evidence.

• Experience as Subject Matter Expert (SME) and/or Trainer and/or Mentor.

• Previous leadership role is a plus (Assoc Clinical Lead Assoc Site Activation Manager Centralized Monitoring Lead TMF Manager or Project Management Analyst / Senior or Principal Project Support Coordinator with minimum 2 years of experience in the role).

• Experience with Regulatory Management systems and Contract Management systems is a plus.

• Experience with advanced Excel features is a plus (Macros Analytics).

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

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements misrepresentations or material omissions during the recruitment process will result in immediate disqualification of your application or termination of employment if discovered later in accordance with applicable law. We appreciate your honesty and professionalism.