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1. Member of the Clinical Trial Team, support the trial Lead to ensure trial deliverables are met according to timelines, budget, quality standards and operational proce-dures.
2. Work with the Trial Lead on investigators meeting organization and all internal meetings related to the clinical trial execution and operational excellence
3. In collaboration with the GBS or Sponsor Medical representative, contribute to the trial data ongoing medical/scientific quality review,
4. Project / trial allocation plans within given indications and implementation to ensure optimum patient accessibility, resource utilization / allocation and country. Work closely with the Regional Monitoring Managers on trial feasibility and subsequent patient enrolment. Develop contingency plans as appropriate.
5. Ensure and sign off high quality Monitoring Plans and other study plans and reports.
6. Work with GBS Line Functions and partners to identify potential operational issues and implement actions to resolve them. Work with GBS Clinical Data Sciences team to ensure timely availability of reports / activities needed to track trial performance. Escalate issues endangering data quality and deliverables to the next level if no solution can be achieved
7. Work with Trial Lead and trial Coordinator for the development, management and tracking of trial budget (internal and external costs) working closely with the GBS Finance and Sponsor representative. Accountable for accuracy of trial information in all trial databases and tracking systems. Support the Trial Lead in the preparation and presentation of the trial budget to Sponsor representatives. Ensure cost reconciliation after trial completion in appropriate payment systems,
8. Work with Drug Supply Management to ensure appropriate planning and of trial medication as well as keep overview of drug availability.
9. In collaboration with trial Lead, may contribute to the development of protocol as well as clinical sections of regulatory documents like Investigators Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions, review of clinical trial application packages (as needed).
Minimum Requirements
Advanced degree or equivalent education/degree in life science/healthcare is required. Fluent English (oral and written).
1. 8 years Clinical Operations experience with at least 4 years managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organization.
2. Proven ability to work independently in a complex matrix environment (including remote).
3. Good project management skills
4. Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and global clinical development process.
5. Demonstrated presentation and diplomacy skills. Negotiation and conflict resolution skills.
6. Strong customer oriented mindset
7. Ability to resolve issues with minimal supervision and understand when to escalate.
8. Willingness to act accountably in project / trial management
,Keyskills :
trialmanagement projectmanagement goodclinicalpractice budgeting qualitystandards paymentsystems functional digitalconversion dataquality cardiology mentoring adobecreativesuite clinicaldata clinicalresearch conflictresolution qualitymonito