Study Start-Up Manager (Home-based) – IQVIA Biotech

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

In anticipation of future growth, IQVIA Biotech is proactively seeking to identify a Study Start Up Manager.

Internal Job Description

IQVIA Biotech is now hiring for a Study Start – Up Manager, this is a home-based position.

The SSU Manager is responsible for providing customer-focused leadership in the execution of operational strategy and management of start-up activities for projects or programs. This includes the overall management and oversight of the following processes: site feasibility, regulatory approval, and site contracts.  May be assigned to manage the site start-up activities for a country, region, or entire global trial.

The SSU Manager also has responsibility for maintaining internal tracking for study site status from initial site contact through site initiation. This position works directly with Director of Clinical Monitoring, VP Operations, Project Managers and Clinical Trial Managers in setting priorities for study start up.  This individual works with the VP of Operations to set forward looking strategy for the Department as it strives to meet its internal objectives to support overall IQVIA Biotech top and bottom-line performance.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

• Serve as SSU Manager within region for project(s) or programs or service line. Lead SSU team or service line in all the activities. Monitor team efficiency, quality and adherence to project timelines, budget, SOPs and WPs.

• Develops, with the input of regulatory and contracts, a study specific SSU plan.

• Communicates overall site activation status to project manager and Client

• Directs the process for the selection of study sites and investigators.  Attend project meetings with cross functional department leads to provide strategy for identifying potential investigators.

• Works with sponsors and internal team members to establish regulatory requirements and contracts necessary for start-up.

• Where applicable, provide work instructions to team members in preparation of regulatory submissions.

• Establishes processes for the collection and initial review of regulatory packets and site contracts for investigator sites.

• Facilitates communication within the clinical team (e.g. SSU Specialist, Project Managers, Clinical, Regulatory Affairs, Vendors, and Contracts Department) during site start up, closely monitoring site visit schedule to ensure site activation timelines are met.

• Works with SSU Leadership team to implement QC/QA processes that are effective in providing high quality deliverables to our internal and external teams.

• Directs the development of study start up Review plans. Assures team members incorporate required elements of the Regulatory Plan and Monitoring Plan in accordance with Good Clinical Practices (GCP).  Works with SSU Leadership Team to implement processes that assures compliance.

• Works with SSU Leadership Team to design, develop, and update Standard Operating Procedures & WP’s for all SSU functions.

• Maintain and manage SSU data tracking entries in database. Review for completeness and accuracy.

• Review and provide feedback to management on site performance metrics.

• Developing appropriate early warning systems of potential obstacles to the successful completion of study start-up; analyzes information and develops innovative solutions to challenges

• Responsible for escalation of issues and reporting progress to study teams and clinical management weekly, including plans for addressing/mitigating risks/gaps.

• Reviews and approves reports and manuscripts, as necessary.

• Maintains current knowledge of relevant country regulations, and GCP and ICH Guidelines for clinical research.

• Participates in business development activities to grow IQVIA Biotech ’s business.

• Facilitate process improvement efforts both within the department and in cooperation with other departments.

External Job Description

External Job Description

IQVIA Biotech is now hiring for a Study Start – Up Manager, this is a home-based position.

The SSU Manager is responsible for providing customer-focused leadership in the execution of operational strategy and management of start-up activities for projects or programs. This includes the overall management and oversight of the following processes: site feasibility, regulatory approval, and site contracts.  May be assigned to manage the site start-up activities for a country, region, or entire global trial.

The SSU Manager also has responsibility for maintaining internal tracking for study site status from initial site contact through site initiation. This position works directly with Director of Clinical Monitoring, VP Operations, Project Managers and Clinical Trial Managers in setting priorities for study start up.  This individual works with the VP of Operations to set forward looking strategy for the Department as it strives to meet its internal objectives to support overall IQVIA Biotech top and bottom-line performance.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

• Serve as SSU Manager within region for project(s) or programs or service line. Lead SSU team or service line in all the activities. Monitor team efficiency, quality and adherence to project timelines, budget, SOPs and WPs.

• Develops, with the input of regulatory and contracts, a study specific SSU plan.

• Communicates overall site activation status to project manager and Client

• Directs the process for the selection of study sites and investigators.  Attend project meetings with cross functional department leads to provide strategy for identifying potential investigators.

• Works with sponsors and internal team members to establish regulatory requirements and contracts necessary for start-up.

• Where applicable, provide work instructions to team members in preparation of regulatory submissions.

• Establishes processes for the collection and initial review of regulatory packets and site contracts for investigator sites.

• Facilitates communication within the clinical team (e.g. SSU Specialist, Project Managers, Clinical, Regulatory Affairs, Vendors, and Contracts Department) during site start up, closely monitoring site visit schedule to ensure site activation timelines are met.

• Works with SSU Leadership team to implement QC/QA processes that are effective in providing high quality deliverables to our internal and external teams.

• Directs the development of study start up Review plans. Assures team members incorporate required elements of the Regulatory Plan and Monitoring Plan in accordance with Good Clinical Practices (GCP).  Works with SSU Leadership Team to implement processes that assures compliance.

• Works with SSU Leadership Team to design, develop, and update Standard Operating Procedures & WP’s for all SSU functions.

• Maintain and manage SSU data tracking entries in database. Review for completeness and accuracy.

• Review and provide feedback to management on site performance metrics.

• Developing appropriate early warning systems of potential obstacles to the successful completion of study start-up; analyzes information and develops innovative solutions to challenges

• Responsible for escalation of issues and reporting progress to study teams and clinical management weekly, including plans for addressing/mitigating risks/gaps.

• Reviews and approves reports and manuscripts, as necessary.

• Maintains current knowledge of relevant country regulations, and GCP and ICH Guidelines for clinical research.

• Participates in business development activities to grow IQVIA Biotech ’s business.

• Facilitate process improvement efforts both within the department and in cooperation with other departments.

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IQVIA is an EEO Employer – Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.