Manager, Clinical Trial Transparency

About the job

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.

THE ROLES:

The Manager, Clinical Trial Transparency (“CTTM”) provides subject matter expertise on clinical trial transparency activities. The Manager supervises teams in their support of transparency services, oversees the quality of work performed, and liaises with clients/stakeholders. This role is a line management role and has direct reports.

Responsibilities

• Serves as operations expert in clinical trial transparency activities including interpreting and applying global regulatory requirements
• Serves as subject matter expert for and supports technology enablement for clinical trial transparency
• Provides project management and co-ordination expertise to the Xogene transparencies teams on one or more projects
• Provides line management support for transparency staff at one or more Xogene sites and/or projects
• Performs and/or has oversight of clinical trial posting activities for ongoing drug, device, and biologic clinical trials including: receive & review hardcopy and electronic forms, requirements assessment, authoring, data entry on multiple websites, quality control functions, maintenance of document archives, and updating project tracking systems
• Performs and/or has oversight of clinical trial document redaction to remove or anonymize confidential and personal information
• Tracks status of all active clinical trials and records clinical trial transparency activity and compliance for assigned clients/projects
• Manages all administrative aspects of maintaining US and international clinical trial registry and results database website postings
• Manages the day-to-day planning and activities of the projects and identifies/mitigates risks
• Organizes team meetings and team events, including new project team member on-boarding and training
• Provides continuous process improvement and allow regular constructive feedback to project team members

Required Knowledge, Skills and Abilities

• Bachelor degree in Science or commercial degree; Masters degree preferred
• 5-7 years post-graduate experience in clinical trial transparency
• Excellent organizational and time management skills
• Team management skills/experience
• Meticulous attention to detail
• Strong computer skills with Microsoft Excel, Powerpoint, Word
• Excellent communication skills
• Intercultural understanding with a global perspective
• Knowledge of drug development or clinical science
• At least two years of supervisory or line management experience