CTT Member

ABOUT XOGENE

Xogene is a leader in innovative technologies and expert services to meet global clinical trial transparency requirements. Since 2010, Xogene has been offering a suite of transparency services to meet evolving regulatory needs, from helping to build a newly emerging transparency capability to augmenting an already mature process.

Combining deep transparency expertise with a modern technology stack, Xogene also provides software solutions to automate processes and track myriad studies, regulations and statuses.

Our expertise ranges from clinical trial registration and results reporting, document redaction and lay summary development, to SAS/XML support, data sharing, online study tracking solutions, and building/hosting websites.

Xogene is headquartered in New Jersey with offices in Vienna, Austria and Gurgaon and Pune, India. For more information, visit us at http://www.xogene.com.

POSITION OVERVIEW

Offering a suite of transparency services, Xogene is a leader in innovative technologies and expert services to meet global clinical trial transparency. Combining deep transparency expertise with a modern technology stack, Xogene provides software solutions to automate tedious processes and track myriad studies, regulations and statuses. Our four unique technology solutions offer different ways to streamline and enhance various aspects of the trial process, including study design, patient recruitment, data collection, monitoring, and analysis. These technologies contribute to improving the efficiency, quality and participant experience in clinical trials.

As we continue to expand, we are seeking an experienced Clinical Trials Transparency Specialist and Sr. Specialist (“Specialist”) to join our dynamic team and contribute to our ongoing growth and success. The Specialist is a fast-paced, detail-oriented role that provides quality control of various clinical trial transparency offerings including registration and results postings, redaction and anonymization of documents, and plain language summaries. The Xogene Specialist is an integral member of the organization, performing a diverse range of operational and/or client-focused activities that directly impact the success of the clinical trial transparency projects. This role requires 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 TASKS AND 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 hardcopy and electronic forms, assessing requirements, authoring/reviewing/QC of plain language summaries, managing data entry on multiple websites, performing quality control functions, maintaining document archives, and updating project tracking systems.
• Performs and/or oversees clinical trial document redaction projects to remove or anonymize confidential and personal information.
• Tracks status and communicates with the client-side Disclosure Coordinators, if needed

• Proactively stays informed on current 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 experts.
• Proactively manages project timelines and ensures project team and management are informed when requirements cannot be met, or deliverables are at risk.
• Supports all administrative aspects of maintaining US and international clinical trial registry and results database website postings.
• Acts as point of contact for inquiries both internal and external.
• Provides continuous process improvement and allows regular constructive feedback to project team members.

• Bachelor’s degree in science or commercial degree; Master’s degree preferred
• 2-4 years medical writing and/or experience in clinical trial transparency
• 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
• At least one year of supervisory or line management experience