Senior Manager, Clinical Trial Management Solutions (Trial Master File)
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
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- 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 period10 days
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
- Consolidated retirement plan (pension)
- Savings plan (401(k))
- Long-term incentive program
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What This Job Offers
Job Type
Full-time
Career Level
Senior
