Scientist-Jobs in Singapur

Heads, a global CRO and part of Veeda Lifesciences, is seeking a Clinical Research Associate (CRA) based in Germany for its expanding international hematology/oncology clinical trials program.

This is a full-time position.

The CRA is responsible for ensuring that the conduct of clinical trials at selected investigational sites complies with the approved protocol/amendments, ICH GCP guidelines, SOPs, and applicable laws and regulations. They serve as the primary communication link between the Sponsor, Investigators, and study personnel, fostering successful working relationships. The key responsibility is to ensure the rights of subjects are respected and that all clinical trial data are accurate, complete, and verifiable from source documents.

• Ensure compliance with the company's Quality and Information Security Management Systems, ICH GCP guidelines, local and international legislation, including data protection laws.
• Report deviations from protocols, guidelines, or legislation to the Line Manager according to SOPs.
• Conduct pre-study visits to evaluate potential investigational sites.
• Collaborate with Regulatory Affairs and Clinical Operations for submissions and contracts, managing hospital IEC submissions and approvals.
• Prepare study contracts and relevant documentation for financial management.
• Explain study purposes, setup, and procedures to Investigators; provide training and support.
• Maintain and update Clinical Trial Files, ensuring proper collection of documents.
• Supply sites with study medication, verify drug accountability, and oversee shipment, storage, and disposal.
• Monitor trial conduct at sites, ensuring Investigator compliance and qualifications, verifying data, and verifying informed consent procedures.
• Manage safety reporting, AE/SAE training, and ensure timely submissions to authorities.
• Verify proper dispensing of study drugs and document all monitoring activities.
• Participate in meetings, support audits and inspections, and collaborate on feasibility assessments.
• Assist with financial issues, manage subject enrollment, and optimize patient procedures.
• Participate in departmental planning, SOP development, and provide coaching to less experienced CRAs.
• Monitor the DACH region.

• Bachelor’s or Master’s degree in Health Sciences preferred.
• 6-12 months’ CRA work experience.
• Fluent in English and German, both oral and written.
• ICH GCP training (desirable).
• Proficient in computer skills.
• Strong communication and organizational skills.
• Ability to work independently and as part of a team.
• Effective communication with site personnel.
• Ability to handle stressful situations, flexible with timelines, and multitask.
• Adherence to SOPs, guidelines, regulations, and ethical principles.
• Willingness to travel frequently, including evenings and overnight stays.

Join our multidisciplinary team of scientists and healthcare professionals in a friendly work environment. We offer a competitive remuneration package.

We respect your privacy and consider Data Protection a core operational principle. For details on data processing, visit our Privacy Notice to Candidates: https://heads-research.com/candidates-privacy-notice/