Senior Clinical Research Associate - rekrutacja online

For our Client - an international, original pharmaceutical company, in connection with the development of structures we are looking for:

The Senior Clinical Research Associate (SCRA) acts as site manager between site staff and company, working within Polish Affiliate supporting one or more clinical trial(s) in a development programme. CRA is responsible for trial deliverables and ensuring the highest possible data quality in company.

The position is based in Warsaw, reports to Clinical Team Leader, Poland and will require travelling up to 60% of the time.

Essential Responsibilities

• Work within the respective country with one or more clinical trials, representing the local team in the trial team led by the Trial Manager
• The primary point of contact between site staff and company, act as an ambassador for the company and contributes to making company the preferred partner in clinical trials
• Leadership of site management for the selection and initiation of sites as well as conduct and closing activities of the appointed studies in compliance with local regulations, ICH-GCP, company procedures and protocol requirements to ensure data quality and study subject protection
• Overall site management, including site monitoring and remote monitoring
• Ensure that trial site staff is properly trained to conduct the trial(s), provide necessary training and identify and flag any development areas and implement mitigations
• Managing trial sites to meet patient recruitment and retention target, aimed at successful completion of the clinical programme
• Close collaboration with relevant roles to ensure successful conduct of the trial, such as Trial Manager, CTA and Team Leader
• Ownership of site management and trial conduct and timely flagging of any critical issues proactively to Trial Manager and relevant roles within local organization
• Agree on tasks responsibility split and timelines with CTA within the trial, including timely provision of trial documentation
• Contribute to or drive Scientific Recruitment and Retention (SRR) planning and execution, in collaboration with Trial Manager
• Responsible for site preparedness for audits and inspections and all related follow-up activities
• Other activities, such as Health Authority and/ or Ethics Committee communication, site contracts or local trial budget, as agreed with the Team Leader.

Qualifications

• Bachelor or master degree in Life Sciences or equivalent
• Experience from a similar position in the pharmaceutical industry or Clinical Research Organisation (CRO), preferably min. 2-3 years
• Ability to build and maintain relationships with sites
• High focus on delivery and quality
• Excellent communication and negotiation skills
• High degree of trustworthiness
• Adequate English, Polish verbal and writing skills, e.g. enabling understanding of the protocol and study documents as well as writing monitoring reports
• IT proficiency
• Proven decision making and problem-solving capabilities
• Ability to manage multiple priorities
• Team oriented personality with high degree of flexibility
• Ability and willingness to adjust quickly to new situations in a continuously developing environment
• Act as an ambassador for NN values
• Flexibility is very important due to the large number of minor and major tasks coming from different customers
• Valid driving license