Job Overview
- 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
Essential Functions
- 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. Reviews and signs off monitoring reports
Experience 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
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
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe
The potential base pay range for this role, when annualized, is $93,100.00 - $232,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.