Global Clinical Development Operations Trial Leader | partially home based | Zuid-Holland
Location: NetherlandsSIRE® 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, Biotechnology and Clinical Research organisation, based in Zuid-Holland Netherlands.
Furthermore, you serve as the single point of end-to-end accountability for assigned programs leading the program teams on a global, regional level or local level, while partnering with the Global Clinical Development Operations Program Leader, Operations Head, and Global -Clinical Trial Assistant to ensure overall program delivery at the global, regional and country level.
Must be available on-site in Leiden 3 days a week, can work flexible on other days.
2. Being accountable for delivery of assigned programs within agreed budget.
3. Monitor patient enrolment at global and or regional level and ensure timely and accurate documentation and communication of project progress.
4. Maintain project compliance within all applicable health authority regulations, guidelines, internal SOPs and processes.
5. Ensure correct and timely reporting AEs/SAEs/PQCs, as appropriate.
6. Ensure Inspection readiness by maintaining complete, accurate and timely data and essential documents in systems utilized for program management (e.g. CTMS and VTMF) according to expectations (metrics) and archiving retention requirements where applicable.
7. Keep yourself inspection ready and knowledgeable for current work by complying with relevant training requirements.
8. Identify and proactively manage issues in a timely manner.
• Minimum of 8 years of clinical research experience in the pharmaceutical industry or CRO. Other relevant experiences and skills may be considered.
• Project management skills and proficient communication skills are required.
• Ability to work in a virtual and highly matrixed environment.
• Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures.
• Full time strongly preferred, 36 hours in case of strong fit is discussable.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees Roffelsen.
The Company
They develop vaccines that are the first or best in their class and protect against some of the world's most life-threatening infectious diseases. The pathogens against which vaccines are developed include Ebola, Respiratory Syncytial Virus (RSV), Human Immunodeficiency Virus (HIV), Extra-intestinal Pathogenic E. coli (ExPEC), Methicillin-Resistant Staphylococcus Aureus (MRSA), polio and influenza.Role Description
You are accountable for end-to-end operational management of data generation activities or managed access requests. This includes start-up, execution, close-out, analysis and reporting according to planned timelines and budget, and with high quality standards per company procedures and regulatory requirements.Furthermore, you serve as the single point of end-to-end accountability for assigned programs leading the program teams on a global, regional level or local level, while partnering with the Global Clinical Development Operations Program Leader, Operations Head, and Global -Clinical Trial Assistant to ensure overall program delivery at the global, regional and country level.
Must be available on-site in Leiden 3 days a week, can work flexible on other days.
Responsibilities
1. Single point of accountability for end-to-end operational management of the assigned programs2. Being accountable for delivery of assigned programs within agreed budget.
3. Monitor patient enrolment at global and or regional level and ensure timely and accurate documentation and communication of project progress.
4. Maintain project compliance within all applicable health authority regulations, guidelines, internal SOPs and processes.
5. Ensure correct and timely reporting AEs/SAEs/PQCs, as appropriate.
6. Ensure Inspection readiness by maintaining complete, accurate and timely data and essential documents in systems utilized for program management (e.g. CTMS and VTMF) according to expectations (metrics) and archiving retention requirements where applicable.
7. Keep yourself inspection ready and knowledgeable for current work by complying with relevant training requirements.
8. Identify and proactively manage issues in a timely manner.
Requirements
• Bachelor’s degree or equivalent required, preferably in Life Sciences.• Minimum of 8 years of clinical research experience in the pharmaceutical industry or CRO. Other relevant experiences and skills may be considered.
• Project management skills and proficient communication skills are required.
• Ability to work in a virtual and highly matrixed environment.
• Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures.
• Full time strongly preferred, 36 hours in case of strong fit is discussable.
Other information
You can submit your application until the 12th of November.Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees Roffelsen.
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