Senior Clinical Systems Implementation Lead

Merck & Co.; Rahway (NJ); Hybride; USD 173 000 - 273 000; Plein temps

Avantages offerts par ce poste

Hybrid work

Résumé du poste

Merck & Co. is seeking an experienced Clinical Systems Implementation Team Lead to oversee validation, implementation, and adoption of clinical trial applications. You will manage a team, partner with IT and business stakeholders, and ensure SDLC compliance.

Responsibilities include driving change, building business cases for innovation, and coordinating audits and inspections. This role requires global collaboration and strong leadership in a hybrid work environment.

Qualifications

• Two to five years of people management experience is required.
• Broad understanding of drug development - safety, clinical trials, trial design, data management, trial operations, regulatory, privacy, ICH, and GCP.
• Ability to quickly gain thorough understanding and become subject matter expert in a new business area as needed.
• Strong verbal & written communication skills - able to present info confidentially and effectively to leadership, peers, and team.
• Ability to interact with all levels of management, exert influence to achieve results without authority and manage senior/Executive stakeholders.
• Project and Resource management experience.
• Deep knowledge of Clinical Trial processes and quality management and control tools.
• Experience with critical clinical systems such as CTMS, eTMF, EDC, clinical portal and MS Office tools.
• Understanding metrics and being able to identify trends.
• Experience in System Validation and Implementation, systems analysis and maintenance / support.
• Fluency with cross-functional interdependencies and enabling tools/technologies.
• Able to identify critical inputs/outputs that drive business processes and dependencies on workflow vs dataflow.
• Exposure to a global environment with multi-cultural and country requirements awareness.
• Leadership skills, analytical ability, good judgment, multi-tasking, conflict resolution, discretion.
• Customer service orientation and ability to work with clients, vendors, quality and IT staff.
• Experience in training user community.

Responsabilités

• Lead cross-functional SMEs and end-users to assess needs and identify solutions with IT.
• Monitor technology trends and map capabilities to requirements to enable processes.
• Create high-impact business cases for innovation and advance solutions to scale.
• Collaborate with UX experts to gather early and ongoing user feedback.
• Engage sponsors to develop and drive technology and innovation roadmaps.
• Identify KPIs to measure outcomes and improve operations.
• Provide workstream leadership as needed for larger initiatives.
• Create change and communication plans to drive adoption and share lessons learned.
• Own assigned systems, including migrations and decommissioning.

Connaissances

Adaptability

Benchmarking

Business Process Re-Engineering

Clinical Systems Implementation

Cross-Functional Teamwork

Data Analysis Tools

Decision Making

Good Manufacturing Practices

Innovation

IT Implementation

People Leadership

Professional Integrity

Quality Control Management

Risk Management

Strategic Planning

Formation

BS degree + 10 years exp

MS/MBA/JD + 8 years exp

PhD + 5 years exp

Description du poste

Merck & Co. is seeking an experienced Clinical Systems Implementation Team Lead to oversee validation, implementation, and adoption of clinical trial applications. You will manage a team, partner with IT and business stakeholders, and ensure SDLC compliance.

Responsibilities include driving change, building business cases for innovation, and coordinating audits and inspections. This role requires global collaboration and strong leadership in a hybrid work environment.