Role OverviewThe Study Start Up Specialist coordinates and oversees all activities related to achieving the goal of site activations in accordance with the contract, trial protocol, and other study-specific requirements. They take leadership and act as the primary point of contact for Sponsor and internal stakeholders during the study start-up process.
What You Will Do
The Study Start Up Specialist assumes leadership during the study set-up process, ensuring the development of a start-up strategy, effective and rapid coordination and management of regulatory deliverables, driving the team to meet agreed targets and comply with agreed procedures, trackers, and templates.
Why It Might Be a Fit
The Study Start Up Specialist provides regulatory strategic input to internal and external customers, promptly identifies and addresses any risk/potential risk by implementing preventive measures, and prepares regulatory information to support regulatory submissions for initial authorization and maintenance.
Requirements
- Bachelor's Degree in Chemistry or Life Sciences, Nursing or equivalent experience
- Minimum 5 years within pharmaceutical/CRO industry
- Proven ability to successfully manage multi-country projects in start-up
- Excellent organizational and management skills
- Strong planning, strategizing, managing, progress monitoring, scheduling, problem-solving, and critiquing skills
- Good interpersonal skills in a fast-paced, deadline-oriented, and changing environment
- Excellent self-motivation and motivation skills
- Outstanding knowledge of ICH GCP across all areas
Benefits
- Training and career development opportunities internally
- Strong emphasis on personal and professional growth
- Friendly, supportive working environment
- Opportunity to work with colleagues based all over the world, with English as the company language
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