Job Description

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.

Join Our Team as an Associate Director, Study Start Up

About this role

As part of our Ophthalmology team, you will work alongside passionate and innovative professionals to ensure our customers achieve their goals.

The Associate Director, Study Start Up is responsible for managing country-level deliverables, timelines, and results for assigned clinical study protocols, ensuring quality, compliance, and efficient study start-up execution.

Key Responsibilities:

• Oversee and deliver the study start-up phase for assigned projects on time, within scope, budget, and quality standards.

• Develop and maintain study start-up plans and track progress across assigned protocols.

• Provide proactive guidance to staff on site selection, submission strategy, amendment strategy, and customer management.

• Support staff in resolving significant study or site issues and escalate risks appropriately.

• Manage assigned budgets, maintain profitability, and ensure timely invoicing aligned with scope of work.

• Provide oversight to local vendors/contractors as applicable.

• Participate in business development activities, including proposals, budget development, and strategic input on country and site selection.

• Line manage staff in an international environment, including training, coaching, mentoring, and identifying process/training gaps.

• Lead process improvement initiatives and act as a key relationship manager for assigned customers.

• Collaborate closely with global functions such as Project Management, Data Management, Statistics, Medical Writing, Regulatory, and Safety.

Qualifications:

• Bachelor’s degree, preferably in life sciences or nursing, or equivalent.

• Minimum 8 years of industry experience in clinical research, including at least 5 years in global clinical trials.

• Thorough knowledge of the clinical drug development process and study start-up phases.

• Strong understanding of GCP/ICH guidelines and applicable regulatory requirements.

• Excellent organizational, communication, customer service, and problem‑solving skills.

• Proven ability to deliver results to quality, time, and financial metrics.

• Strong judgment and decision‑making abilities.

• Ability to build and maintain effective working relationships with colleagues, managers, and customers.

• Ability and willingness to travel.

For candidates based in Italy - we welcome applications from candidates belonging to protected categories under art. 1 L. 68/99.

For candidates based in Sapin - TFS is committed to equal opportunities. All our vacancies are open to people with disabilities, in accordance with the General Law on the Rights of Persons with Disabilities (Royal Legislative Decree 1/2013).

What We Offer

We provide a competitive compensation package, comprehensive benefits and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients

A Bit More About Us

Our journey began over 30 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology and Ophthalmology.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration.

Together we make a difference.