Study Manager

Job Overview

Responsible for the successful planning, implementation and execution of clinical study (ies) to verify and validate clinical software, instrument platforms, assays and biomarkers developed. Functionally responsible for all clinical monitoring activities throughout the duration of each clinical trial. Assures clear external/internal team communication, process documentation, and compliance with sponsor and departmental processes along with Good Clinical Practices and procedures set forth.

DISTINGUISHING CHARACTERISTICS:

This is a multiple incumbent job.

TECHNICAL RESPONSIBILITIES:

● Plans and conducts clinical trial programs for assigned area of focus for registrational trials and/or non-registrational and/or research studies for US or outside US with minimal supervision.

● Responsible for the implementation and maintenance of the clinical trial-related policies, as well as processes and procedures related to the Product Development Process.

● Works with the project manager to define and manage budgets and timelines for each study and is accountable for delivery of documentation to meet study milestones. Manages investigational site and clinical study agreements.

● Provide technical expertise on the development of clinical trial documents and records (clinical validation plan, protocols, monitoring plans, manual of operations, investigator training materials, clinical trials report, study forms, templates and monitoring reports, Instructions for Use etc.). Ensures informed consent form is prepared, if applicable.

Serves as subject matter expert with external resources and contacts at various management levels concerning clinical operations or scheduling of specific phases of clinical studies.

● Oversees the review and monitoring of clinical study data and data quality in collaboration with Biometrics and Clinical Science Lead as needed.

● Outline safety issues and planned mitigations in collaboration with the Clinical Science Lead.

● Maintains strong, collaborative relationships with cross-functional leaders, key internal and external stakeholders and other alliance partners in meeting business goals and ensure operational excellence.

● Leads site selection activities.

● Acts as liaison with the Clinical, Medical and Regulatory groups and other Diagnostics / Pharma partners to identify and implement collaborative studies, regulatory activities, and other programs.

● Responsible for adhering to regulations, guidelines and departmental standard operating procedures.

● Manages relationships with international opinion leaders, investigators and key customers.

● Manages internal and external resources to support scheduled studies.

● Oversees all study related activities for complex studies with minimal supervision.

● Represents the department at cross-functional project teams and at the Business Unit level.

● Implements global study support strategies and initiatives with minimal supervision.

● Regularly interacts with executive management on work of area(s) that affect larger organizational goals.

● Responsible for assessing processes and establishing plans for improvements with input from senior management.

PEOPLE LEADER RESPONSIBILITIES (if applicable):

● Provides effective leadership of direct reports.

● Ensures direct reports comply with regulations, SOPs and protocols.

● Develops Clinical Research Associates and ensures training, development and qualification.

● Provide direction and mentorship to staff including setting goals that align with corporate, functional and project goals.

● Positions with people management responsibility have HR responsibility for workforce planning, interviewing, selection decisions, performance management, corrective action, termination decision, compensation decisions, and handling employee concerns or complaints.

● May review technical deliverables of direct reports to provide feedback

MINIMUM QUALIFICATIONS:

Formal Training/Education:

● Bachelor degree in scientific discipline or related field required.

Experience:

● 8+ years of experience in clinical trials is required, 10+ preferred

Experience in diagnostics, biotechnology and/or pharmaceutical clinical research with responsibilities for managing all major aspects of strategic planning, organization, implementation, and delivery of clinical programs.

Knowledge, Skills, and Abilities:

● Demonstrated ability to work collaboratively across all levels of an organization and to lead influentially

● Ability to operate and lead efficiently in a heavily matrixed and multi-site organizational structure.

● Ability to build, manage, and maintain high performing clinical operations’ teams in a fast-paced, dynamic and global environment.

● Understands the US and European Medical Testing environments and relevant professional societies and guidelines (e.g. FDA, CE-Mark IVD Directives, CAP, CLIA, WHO, IASLC, ASCCP, etc.).

● Excellent knowledge of applicable standards and regulations for clinical trials and laboratory conduct (CFR, ICH-GCP, Federal guidelines, GMP, GLP, ISO, etc.)

● Ability to initiate and effectively lead change efforts, and ensure people accountability.

● Strong communication, presentation, and interpersonal skills and ability to build close working relationships across the organization and with alliance partners.

TRAVEL REQUIREMENTS:

Travel Requirement: Approximately 20% of time travel domestic and/or international.

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

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.