Global Trial Manager
Opis stanowiska pracy
SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical organisation, based in Antwerpen Belgium.
The CompanyThe company is a multinational healthcare leader with a diversified portfolio of prescription medicines, vaccines, innovative medicines and medical devices.
Role DescriptionYou will be working in the role of a Global Trial Lead (GTL) within the Global Clinical Operations (GCO) organization with a focus on the oversight of documentation, support, feedback, etc. GCO is a service organization which performs clinical studies for all pharmaceutical products under development by one of the company's branches. The clinical studies are often global studies, and the data generated in these studies are collected to become part of the marketing authorization application dossier which is prepared and submitted by Global Regulatory Affairs (GRA). GCO is organized, just as GRA, along therapeutic areas: Immunology, Oncology, Infectious Diseases, Cardiovascular disease and CNS.
From the digital technology aspect, you will be working specifically on the Integrated Smart Trial Engagement Program (iSTEP). This is a program combining smart technologies (smart packages, smart phones, scanning devices) with an integrated platform, and is designed to enable personalized end-to-end patient engagement plus automated clinical supplies and data management in clinical studies. Not only will iSTEP transform the way clinical trials are done, this initiative has also been a testimonial of excellent collaboration, creativity and dedication of a “first-class” cross-departmental and cross-sector team, as well as state-of-art external partnerships with platform, digital and package vendors.
The iSTEP program is being implemented and verified within the organization and, as the Digital Global Trial Lead (Digital GTL), this profile will be executing the iSTEP program on one or more clinical studies from within Enabling Business Information Solutions (EBIS), a department who supports operationalizing new technologies into the business. In this role you will lead all iSTEP activities needed for the clinical study ensuring study team oversight & engagement (change management) as also providing explanation, training, escalation etc. where needed.
Responsibilities- Represent the company and the organization adequately to the customers and other external parties.
- Base all actions on Credo.
- Protect the rights of others; protect privacy and company assets, particularly information as the key asset.
- Conduct business in line with the HCC, company policies and procedures, including applicable SOPs, always having the ethical aspect in mind.
- Maintain adequate communication with relevant parties within and outside the company
- Comply with ICH-GCP and all applicable local laws and regulations.
- Report (suspicion of) fraud or scientific/ethical misconduct as appropriate.
- Regularly update information in applicable systems and templates.
- Contribute to the development and improvement of departmental procedures and processes and templates in the scope of the company’s effort towards Continuous quality improvement.
- Maintain quality standards and timelines that are consistent with business needs.
RequirementsLeadership and Team working:
- Ability to manage and support the activities of the Local trial and Site Managers and other local staff assigned to the trials
- Managing workloads
- Passion for digital technologies and how these are implemented in clinical studies
- Ability to organize multiple complex priorities and projects and use a range of techniques to identify and resolve trial-related problems
- Understand and apply coaching theory and skills and select appropriate coaching structure to suit individual needs
- Change management – understand how to cope with change and influence/motivate others to deal with change
Procedures and Processes:
- Possess a comprehensive knowledge of and comply with Company SOPs, ICH-GCP, (where appropriate, global) and local national regulations
- Experience and proficiency in the conduct and management of clinical trials
- Clinical Drug Development – thorough understanding of clinical drug development and regulatory procedures and processes within GCO
- Excellent spoken and written English, good presentational and motivational skills
- Computer skills - understand and use a range of computer-based systems to track, monitor and report on investigational site and local trial activity and status
Other informationSome flexibility in working hours is required and possibility to work from home with limited /monthly on-site presence!
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Alexander Wielemaker.
SIRE Life Sciences® is the market leader in life science recruitment. We believe the... recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Rozwiń
- Ostatnia aktualizacja:
- Wymiar etatu:
- Pełny etat
- Rodzaj umowy:
- Własna działalność gospodarcza
- Liczba wakatów:
- Min. doświadczenie:
- 2 lata
- Min. wykształcenie:
- Wyższe licencjackie
- Branża / kategoria:
Praca Medycyna / Służba zdrowia