Senior Manager, Clinical Trial Management Solutions; Trial Master File

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R&D Product Development

R&D Digital

People Leader

Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America

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We are searching for the best talent for a Senior Manager, Clinical Trial Management Solutions (Trial Master File) in Horsham, PA, Spring House, PA, or Raritan, NJ.

The Senior Manager, Clinical Trial Management Solutions (Trial Master File) will provide operational & strategic leadership related to resource, budget, and portfolio management for Trial Master File (TMF) including ownership of the global TMF Business Process role. The Senior Manager will manage the interface between stakeholders, system, and processes, to ensure that the TMF/eTMF capabilities are aligned and effectively executing against identified organizational goals.

The Senior Manager provides input to operational plans with measurable contribution towards the achievement of department results for the Digital Research and Development (R&D) area. This position plays a critical role in the growth and development of the group and contributes to organizational effectiveness, transparency, and communication as a matrix leader driving projects, innovation, and capability growth or as a People Manager, through the recruitment, onboarding, performance management, and development of people while building an inclusive and diverse working environment.

• Leading high-impact technology projects to enhance site staff engagement, digital health, patient recruitment, study management/oversight and digital collaboration across clinical trials.
• Providing business leadership around system release planning and communication including ad-hoc configuration release strategies with IT partners and TMF Vendor
• Facilitating the introduction of new partners into the eTMF system including internal partners and external partners such as CROs, Investigators.
• Managing a high-functioning and diverse team to enable industry-leading, inspection-ready practices for supported capabilities, with a focus on delivering measurable value for stakeholders.
• Exploring internal and external trends to identify emerging technologies and potential opportunities to enhance clinical trial support systems through agile experimentation and design thinking.
• Maintaining a strategic focus on customer satisfaction, ensuring solutions are beneficial, meet regulatory compliance standards and are tailored to the needs of clinical study teams.
• Oversees the application of project management best practices, ensuring all technology implementations follow structured processes, from planning to training.
• Leading anticipation, early detection, prevention and management of risks and issues impacting departmental deliverables and activities.
• Leading knowledge-sharing efforts, fostering lessons learned across the…