Senior Manager, Clinical Trial Management Solutions (Trial Master File)

Johnson & Johnson•Horsham, PA

5d•Hybrid

About The Position

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.

Requirements

Minimum of a Bachelor’s degree is required, preferably in Health, Science, Information Technology or another relevant field.
Minimum of 8 years of relevant experience in clinical trial execution with a Pharmaceutical, Medical Device company, and/or a Clinical Research Organization (CRO)
Demonstrated track record of leadership in Trial Master File (TMF) strategy, operations, and capability development.
Experience supporting regulatory inspections and ensuring TMF compliance in accordance with global regulatory requirements and industry standards.
Proficiency supporting IT systems and related processes that support clinical development, reporting tools, Office 365 applications, and database administration
Solid understanding of the drug development process, including Good Clinical Practices (GCPs) and FDA Code of Federal Regulations
The ability to partner with all levels of management and influence decision making across a matrix organization
Superior communication, business partnering, problem solving, and prioritization skills

Nice To Haves

Project Management or Process Improvement certification
Experience with Veeva Vault eTMF
Experience leveraging Generative AI (GenAI) technologies to identify opportunities for process improvement, automation, and operational efficiency is preferred.

Responsibilities

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 department and with IT to improve system utilization and engagement strategies.
Representing the department during System/Process audits and Sponsor Inspections for supported capabilities.
May serve as Global Development Process Owner for specific capabilities

Benefits

Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year (or 48/56 hours in CO/WA)
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year