Clinical Study Manager at IQVIA

Durham, North Carolina, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotech, Pharma, CROIndustries

Requirements

Bachelor's Degree required
4 or more years of progressive experience in clinical research within biotech, pharma or CRO industry
Proven experience in clinical research including relevant experience as team lead in clinical functions
Experience as CRA is preferred
Recent (within 1-2 years) oncology experience as a study manager, focused in solid tumor or hematological oncology studies
Experience with site management and engagement

Responsibilities

Accountable for regional study delivery with appropriate inspection readiness quality, within agreed timelines and budget
Leads the regional clinical operations team (including oversight of external partners working on the regional level) and acts as point of escalation for resolution of issues within the region for the assigned study
Ensures alignment of regional deliverables with overall study goals
Leads the regional clinical operations team effectively, ensures effective decision making and acts as point of escalation for resolution of issues within the region for the assigned study
Collaborates with key stakeholders in the region and provides regular updates on study progress in the region to senior management and Global Clinical Study Manager as required
Manages regional study budgets
Monitors regional resource utilization over study lifecycle and liaises with functional managers as needed
Leads planning and management of the assigned clinical study(ies) from feasibility through closeout activities for region, in line with global study timelines
Ensures that the clinical study is operationally feasible in the region, drives trial feasibility, country allocation and site selection process for assigned region in collaboration with feasibility managers, country heads, medical affairs and any other stakeholders
Prepares sites for quality assurance audits and inspections, drives responses to audit and inspection findings as appropriate
Collaborates closely with CRAs in the region to ensure proper study execution at the sites and reviews and signs off monitoring reports

Skills

Clinical Research

Study Management

Team Leadership

CRA Oversight

Trial Feasibility

Site Selection

Budget Management

Oncology

Inspection Readiness

Quality Assurance

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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