Clinical Trials Transparency/disclosure Team (remote - Us Or Eu Based) Job in Xogene Services Llc

Position Overview Offering a suite of transparency services, Xogene is a leader in innovative technologies and expert services to meet global clinical trial transparency requirements. Our team of experts provide comprehensive services to the pharmaceutical, biotechnology, and medical industries. Our consulting and strategic services help our clients navigate complex challenges and make informed decisions. As we continue to expand, we are seeking experienced Clinical Trials Analysts, Specialists and Managers to join our dynamic team and contribute to our ongoing growth and success. Our team provides quality control of various clinical trial transparency offerings including registration and results postings, redaction and anonymization of documents, and plain language summaries. Our Clinical Trial Transparency team is an integral part of the Company performing a diverse range of client-focused activities that directly impact the success of our engagement with clients. These roles require subject matter expertise, attention to detail, a positive and strong teamwork/leadership, excellent writing skills and experience interacting in multi-cultural, global working environment. Key Responsibilities Performs project coordination for one or more projects including tracking and corresponding/meeting with clients as needed. Performs and/or has oversight of clinical trial posting activities for ongoing drug, device, and biologic clinical trials including: receiving/reviewing documents, assessing requirements, authoring/reviewing plain language summaries, managing data entry on multiple global and local registries, performing quality control functions, maintaining document archives, and updating project tracking systems. Performs and/or oversees clinical trial document redaction projects to redact or anonymize commercially confidential and personal information. Provides EU CTIS, Health Canada, and EMA P0070 submissions support. Proactively stays informed on current disclosure compliance requirements and serves as subject matter expert in transparency activities including: researching, interpreting and applying global regulatory standards. Supports technology enablement/development for clinical trial transparency as subject matter expert. Proactively manages project timelines and ensures project team and management are informed when requirements cannot be met or deliverables are at risk. Acts as point of contact for inquiries both internal and external. Provides continuous process improvement and allow regular constructive feedback to project team members. REQUIREMENTS Qualifications and Experience Bachelor degree in a relevant field (S.T.E.M. preferred); Advance degree in S.T.E.M. is a plus 1-5 years of experience in Clinical Trial Transparency or Clinical Research Management or Medical Writing Strong interest in life sciences. Excellent organizational and time management skills and self-starter. Meticulous attention to detail. Strong proficiency with Microsoft Office (Excel, Powerpoint, Word, etc). Excellent communication skills. Strong sense of teamwork. Intercultural understanding with a global perspective. Knowledge of drug development or clinical science. Supervisory or line management experience a plus.