Associate Director Study Start Up

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:

• Bachelors 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 problemsolving skills.

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

• Strong judgment and decisionmaking 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. Youll 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.