Clinical Systems Implementation Team Lead

Location: Hybrid; primary location in North Wales, Pennsylvania, USA. The role has an additional listed location. No relocation is provided. Travel requirements are 10%.

Base salary: $173,200–$272,600 per year for the primary location; annual bonus and long-term incentive may apply.

Company

hirify.global develops pharmaceutical and healthcare solutions, including systems supporting global clinical development and clinical trials.

What you will do

• Lead validation, implementation, adoption, operational ownership, migration, and decommissioning of clinical trial applications.
• Partner with Global Clinical Development, R&D IT, functional subject-matter experts, end users, and vendors to assess needs and implement compliant solutions.
• Develop business cases, technology and innovation roadmaps, proof-of-concept initiatives, pilots, and scaled implementations.
• Ensure system quality, SDLC compliance, data stewardship, data governance, secure data flows, audit and inspection readiness, and CAPA follow-up.
• Establish KPIs, change and communication plans, user feedback processes, helpdesk support, release tracking, SOPs, BCPs, and system account reviews.
• Manage team members, allocate resources, support hiring and onboarding, conduct performance reviews, provide feedback, and ensure required training.

Requirements

• BS degree with 10 or more years of experience, or MS/MBA/JD degree with 8 years of experience, or PhD degree with 5 years of experience in Science, Clinical Research, Computer Science, or a similar field.
• Two to five years of people management experience.
• Broad understanding of drug development, including safety, clinical trials, trial design, data management, trial operations, regulatory requirements, privacy, ICH, and GCP.
• Strong verbal and written communication skills, including the ability to present information effectively to leadership, peers, and teams.
• Ability to interact with all management levels, influence outcomes without authority, and manage senior and executive stakeholders.
• Project and resource management experience, analytical ability, good judgment, multitasking, conflict resolution, discretion, and leadership skills.
• Deep knowledge of clinical trial processes, quality management, and control tools.
• Experience with CTMS, eTMF, Electronic Data Capture systems, clinical portals, reporting, and MS Office tools.
• Experience in system validation, implementation, systems analysis, maintenance, support, user training, metrics, trend identification, and cross-functional process and data-flow dependencies.
• Experience working in global, multicultural, and organizationally diverse environments, including understanding country requirements versus US standards.
• Ability to work effectively with clients, third-party vendors, quality teams, IT management, and staff.

Nice to have

• Ability to quickly gain subject-matter expertise in new areas such as Risk-Based Monitoring, Structured Content Authoring, or clinical content standards.
• Experience monitoring technology trends, profiling vendors, and mapping capabilities to business requirements.

Culture & Benefits

• Hybrid work arrangement with first-shift daytime hours.
• Medical, dental, vision, and other insurance benefits for employees and families.
• Retirement benefits, including a 401(k), paid holidays, vacation, compassionate leave, and sick days.
• Inclusive environment that values diverse experiences, perspectives, and collaborative problem-solving.