Global Study Director

Join Our Team as aGlobal Study Director

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

About this role

The Global Study Director (GSD) is a businesscritical role within Study Management
whose main accountability is the operational planning and delivery of high priority and complex clinical studiesor multiple studies within or across program(s).

As part of our SRS team you will be dedicated to one sponsor a global patientfocused pharmaceutical company

Key Responsibilities:

• Accountable from setup through maintenance closeout and study archiving for the operational planning leadership and delivery of multiple studies or overseeing (either within an asset or across assets) single complex/novel studies (such as platform basket etc.) to time cost and quality.
• Contributes expert clinical operational input into project strategy and study design/or documents (e.g. Protocol Concept Sheet).
• May contribute to operational interactions with external entities including regulatory agencies preferred partners/suppliers and external collaborators
• May perform Study Management department leadership tasks as delegated by the Senior Director Study Management
• Lead provide guidance and delegate appropriately to a crossfunctional study team or oversee outsourced delivery activities to ensure the clinical study progresses as planned driving achievement of milestones according to timelines budget and quality standards. May hold accountability and/or oversight of several studies.
• Lead and facilitate communication across all functions. Collaborate with other functions to establish strategies and identify synergies aimed at increasing efficiency of global study teams.

Qualifications:

• University degree (or equivalenteducational/work experience) preferably in
  medical or biological sciences or disciplineassociated with clinical research
• Minimum of 7 years progressive experience in clinical research with at least 5 years of clinical development project management experience (or equivalent)
• Extensive knowledge of ICHGCP relevant regulatory/ethics requirements and clinical/drug development and demonstrated abilities in clinical study management processes and clinical/drug development
• Thorough understanding of crossfunctional clinicalprocesses including data management biostatisticsmedical writing drug safety and regulatory affairs
• Extensive and proven experience project management and in driving operational delivery to timelines cost and quality

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 27 years ago in Sweden in the city of Lund. As a fullservice global Contract Research Organization (CRO) we build solutiondriven teams working towards a healthier future. Bringing together over 800 professionals TFS delivers tailored clinical research services in more than 40 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 decisionmaking 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.