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Trial Master File (TMF) Operations Senior Manager

Achieva Group Ltd
Closing date
20 Apr 2021

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Job Details

Our global pharmaceutical client has a vacancy for a TMF Operations Senior Manager.

Our client is looking for candidates based in Switzerland/ EU.

This is an initial 12-month full time contract.

As Senior Manager in TMF Operations, you will support and guide strategy for TMF advice consistent with global goals.
You will support resource planning activities as well as develop, mentor and coach team. As a Senior Manager, you will ensure operational efficiency and compliance with R&D Standards and training requirements.

• Support and guide strategy for TMF Record Management advice consistent with global goals
• Develop, mentor and coach TMF Operations team through people management, and training activities
• Support TMF Operations resource planning activities and respond effectively to changing priorities
• Ensure operational efficiency and compliance with R&D standards and training requirements

Role Description:
Responsible for:
• Line-management of TMF Operations team members as required
• Ensuring consistent, high quality record management advice for all clinical trial content
• Manage and effectively allocate TMF Operations resources to meet project needs
• Mentoring staff to ensure awareness and consistent following of current operating procedures and best practices

Role Qualifications, Knowledge and Competencies:
Basic Qualifications:
• Doctorate degree & 2 years of directly related experience
• Master's degree & 6 years of directly related experience
• Bachelor's degree & 8 years of directly related experience
• High school diploma / GED & 12 years of directly related experience
• 4 years of direct managerial and/or leadership experience

Preferred Qualifications:
• BA/BS/BSc or RN
• 9 years work experience in life sciences or medically related field, including 6 years of biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)
• Previous management experience of direct reports, including management level staff

• Mastery of global regulatory requirements and guidelines for conducting clinical research and safety monitoring/reporting
• Knowledge of relevant GCP, external and internal regulatory requirements/guidelines
• Understanding of resource management and organizational capacity
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