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Global Trial Budget Manager

Secunderabad, Telangana
Job Code:
  • Biotechnology & Science
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Job Details

1. Using clinical expertise related to the therapeutic area provide direct clinical/operational inputas a member of several Clinical Trial Teams (CTT) to ensure efficient and effective delivery of budgetary objectives across franchises and therapeutic areas2. Provide clinical operational feedback to Clinical Trial Teams on the impact of study procedures, visit design and other operational issues affecting overall study budget3. Support clinical trial team(s) with the clinical operational input for the successful development of trial(s) budget and assist with securing approvals until final. Challenge program/trialtimelines, budget requirements and expenditures to ensure lifetime trial budget accuracy. 4. Collaborate with the Global Trial Lead (GTL) using clinical expertise to identify and defineclinical/operational issues within the study design and the overall impact of amendments and operational changes causing budgetary constraints and inefficiencies. Create, facilitate,implement and lead multiple operational trial budgets with global multidisciplinary line function support and stake-holder management5. As a member of and in collaboration with the Clinical Trial Team (CTT), provide early budget estimates for Operational Clinical Development Plan (CDP)6. Responsible for the accurate completion of clinical and operational portions of the trial commitment form and study Grant Plan Discuss and review clinical/operational issues with GTLand FinOM including the need and impact of clinical study amendments on the global budget 6. May serve on or act as Subject Matter Experts for training or SOP developmentMinimum requirementsEducation(minimum/desirable) Bachelor degree or equivalent education/ degree inlife science/healthcare required. Languages Fluent English (oral and written).Experience/Professional requirement1. At least 3 years experience in pharmaceutical industry including planning and operationalconduct of clinical trials. 2. Thorough medical / scientific knowledge of theassigned therapy area and associated trial design 3. Comprehensive clinical knowledge of the globalclinical study process within the assigned therapy area4. Ability to review, understand and provide clinical operational feedback for multiple large complexprotocols in global clinical trials 5. Demonstrated ability to influence withoutauthority 6. Excellent negotiation and conflict resolution skills7. Demonstrated success in budget planning and management.8. Working knowledge of clinical development process, regulatory requirements and GCP.9. Experience working with clinical data management systems, project managementsystems and reporting tools. 10. Organizational awareness, including experienceworking cross-functionally and in global teams. 11. Robust knowledge of the regulatory and localrequirements within regions and countries.
Additional Degree: B.Pharm. (Pharmacy)

Experience: 3-8


Admin Services/Medical Facilities | Clinical Research
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