Clinical Trial Manager

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Summary:

We are seeking a dedicated individual to oversee the comprehensive management of sponsored clinical trial(s). The role involves contributing to the strategic implementation of operational trials, ensuring successful execution within established timelines and budget. Responsibilities encompass various facets, including feasibility assessment, site selection, study documentation, recruitment, data integrity, and team coordination.

Duties and Responsibilities:

• Accountable for on-time, budget-conscious delivery of trial(s) with unwavering emphasis on quality
• Aid in the creation, refinement, and composition of clinical trial materials, such as Protocols, Case Report Forms, Informed Consent Forms, Study and Communication plans, and Risk Management strategies
• Lead the evaluation of viable countries and research sites for study feasibility
• Coordinate, monitor, and oversee vendor activities
• Develop, manage, and track trial timelines and budgetary allocations
• Facilitate data cleaning and review processes
• Ensure optimal setup and functionality of tracking systems for monitoring trial progress
• Generate comprehensive reports to apprise management of trial conduct status
• Implement effective plans for clinical trial supplies
• Devise recruitment strategies and risk-mitigation tactics, taking prompt action as necessitated
• Contribute to monitoring study safety
• Scrutinize key quality indicators, making informed decisions in tandem with the study team
• Perform preliminary evaluation of vendor invoices for adherence to scope of work
• Assist in instructing CRAs and third-party vendors on protocol specifics
• Spearhead interdisciplinary trial team(s)
• Act as a pivotal point of contact for trial(s), bridging Drug Development and other internal units
• Engage in special projects and working groups as assigned
• Ensure unwavering compliance with Good Clinical Practice and relevant international/local regulations.

Requirements:

• Hold a BS/BA degree or a related scientific qualification
• Possess a minimum of two years' experience within the biopharmaceutical sector or equivalent involvement in global clinical research management
• Proficient understanding of ICH Good Clinical Practices and pertinent regulatory/health authority engagement
• Skillful management of concurrent tasks spanning multiple protocols and therapeutic domains
• Demonstrated aptitude for leadership and creative problem-solving
• Competence in executing diverse clinical trial phases (from initiation to study report)
• Familiarity with collaborative, multidisciplinary work settings; adept at flexible adaptation to evolving environments
• Strong organizational, prioritization, and planning skills, underscored by a customer-focused approach
• Effective communicator accustomed to engaging a diverse range of stakeholders and cultivating positive relationships.

Darwin Recruitment AG is a Zurich based, SECO licensed, privately owned subsidiary of Darwin Professional Staffing Group Ltd (a Global IT Recruitment Consultancy).

Darwin Recruitment AG manages client relationships whilst also utilising Darwin Professional Staffing Group databases and networks to source Candidates and fulfil client requests.

We do not ask for a placement fee from Candidates/Employees.

If you wish to contact a specialist regarding this role, or your job search in general, please contact +41 (0)43 456 29 09

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