Software Architect

Descripción del trabajo

Director, PM / Global Clinical Operations Manager

TEMPORARY position (1 year contract)

About this role

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.

The Global Clinical Operations Manager is responsible to develop, implement and manage assigned clinical trials (CT) of the client (own research and under license products). Collaborates with the Global Clinical Program Lead and Clinical Scientist on the required tasks of the clinical development of new drugs.

Some responsibilities of the role

• Contribute to build Clinical Development plans (evaluate outlines, contribute on synopsis development, timelines, study cost, recruitment rates, geography, etc.)
• Support in the design and execution of the operational strategy of a clinical trial regarding but not limited to countries, sites and CRO selection including all vendors, including preparation, review or approval of all associated documentation (synopsis, protocol, report, timelines, all study plans –statistical, data management, monitoring,…-, technical specifications, IMP related documents, and any other study-related documentation) and management of study budget, including approval of invoices payment and forecast planning.
• Support in the CRO oversight ensuring quality standards and performance indicators defined per program, and also identification of main risks and mitigation activities.
• Responsible for managing Global Clinical Trials low to mid complexity level. CRO selection and management for Phase I to Phase II trials, and low complexity Phase III, including vendors (Photos, Lab, ePRO / eCOA, etc), several geographies, etc. Management of Phase IV interventional trials.
• CRO and other vendors selection for the outsourcing of Clinical Trials and other activities task according to Project needs. Responsible for contracting the Insurance for Clinical Trials thought the accredited broker.
• Leadership of some activities within the “Clinical Study Team” (CST), and organisation of periodic meetings.

Qualifications / Requirements

• At least 4-years of experience in Lead CRAs (or similar), managing clinical trial activities (overall management not required).
• Pharmaceutical Industry business
• Project Management
• Basic Statistics and / or Biometry
• Basic Pharmacokinetics, Clinical Toxicology and Pharmacology
• Preferably Doctor’s degree

A Bit More About Us

Our journey began over 27 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 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 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.