Clinical Systems Implementation Team Lead

Merck; North Wales (Montgomery County); On-site; USD 120,000 - 180,000; Full time

Job summary

Merck is seeking an experienced Clinical Systems Implementation Team Lead to drive validation, implementation, and adoption of trials support applications. The role partners with GCD, IT and vendors to deliver compliant, scalable solutions with strong data governance and SDLC adherence.

You will lead a team, mentor staff, and ensure training, audits, and KPI tracking are in place while advancing the technology roadmap for clinical operations and patient experience improvements.

Qualifications

• Must have 2–5 years of people management experience.
• Broad understanding of drug development, safety, regulatory, ICH and GCP requirements.
• Ability to quickly gain subject matter expertise in a new business area as needed.
• Strong verbal and written communication skills, able to present confidential information to leadership and teams.
• Ability to interact with management at all levels and influence results without formal authority.

Responsibilities

• Lead the Clinical Systems Implementation team in validation, implementation and operation of clinical trial applications.
• Partner with cross-functional SMEs and IT to identify innovative solutions and drive adoption.
• Monitor technology trends and map capabilities to business requirements within GCTO strategy.
• Create business cases for innovation and manage pilots to scale successful solutions.
• Ensure audit readiness and compliance with SDLC, governance, and training requirements.
• Oversee team resourcing, performance reviews, and succession planning.

Skills

People management

Drug development

Subject matter expert

Communication skills

Stakeholder management

Project management

Clinical trial processes

CTMS

eTMF

EDC

Clinical portal

MS Office

Education

BS degree

MS/MBA/JD or PhD

Job description

Job Description

Clinical Systems Implementation Team Lead within BEO manages the full range of activities related to the successful validation, implementation, and adoption of applications that support our company’s clinical trials.

Job Description

Clinical Systems Implementation Team Lead within BEO manages the full range of activities related to the successful validation, implementation, and adoption of applications that support our company’s clinical trials. These systems can be internally and/or externally facing, large or small, vendor or company developed and owned. The role also has people management responsibility for team members supporting similar activities. The team lead should have needed experience and knowledge related to the systems and processes being supported by the team or prioritize gaining this experience once in the role. Partner with various business areas within Global Clinical Development (GCD), with our Research & Development Division-IT and vendors to understand business needs, identify solutions to support those needs and implement solutions with quality focus. The role ensures compliance to company policies, agency regulations and related guidance around technology and applies data stewardship and data governance principles in the management of the applications. Accountable for supporting systems audits and inspections and follow-up of any findings and required CAPA management. Ensure systems quality lead is engaged early in process of upgrading or re-platforming of technology to ensure proper SDLC compliance. Ensure Clinical Systems Implementation team members are properly trained on SDLC requirements and maintain their training. As part of the BEO Leadership Team, identify topics and appropriate guest speakers for monthly department meeting agenda, propose projects/assignment for interns and support activities to identify appropriate candidates for internship, and schedule quarterly business review meetings to share team accomplishments and upcoming activities with other team leads.

Responsibilities

• Partner with a cross-functional team of functional SMEs and end-users to independently assess emerging business needs and work with our Research & Development Division-IT to identify innovative solutions to meet the need.
• Monitor technology trends to match the business needs, profile partners and vendors and map capabilities to requirements to enable business processes in alignment with the GCTO strategy.
• Partner with various business functional stakeholders and our Research & Development Division-IT and create high-impact & high-value business cases for innovation opportunities and advance selected solutions from proof of concept to pilot and implementation at scale, ensuring required due diligence has been carried out, and the solution is audit/inspection ready, if applicable.
• Collaborate with user experience experts and collect early and ongoing feedback from users to ensure solution being developed will provide optimum user experience once enabled.
• Engage with business and IT sponsors to understand overall strategy for existing technology solutions to be able to develop and drive the technology and innovation roadmap.
• Identify and manage the Key Performance Indicators (KPIs) to measure outcomes and success of technology solutions being implemented to improve clinical operations productivity and site and patient experiences.
• As needed, provide workstream or sub-stream leadership or serve as a member for larger technology initiatives.
• Create an effective change and communication plan for technology being enabled to support adoption of and to share best practices and lessons learned.
• Provide system ownership of assigned system(s) and all activities associated with such ownership. Such activities may include system migrations and decommissioning.

Team Management

• Manage team members that provide business system ownership of operational systems.
• Ensure proper allocation of resources to maintain effective system support.
• Identify need for and provide needed justification for additional headcount and if headcount is approved, work with HR recruiter to identify, interview and onboard the right candidate to fill the position.
• Conduct regular 1:1s and ad-hoc meetings to ensure priorities are defined and delivered as planned, provide ongoing constructive feedback, conduct performance reviews, and manage any risks and escalations.
• Obtain sufficient understanding of the applications being supported by team members to be able to proactively identify challenges, address any escalations, provide update to sponsors and serve as a back-up in case of staffing challenges.
• Discuss opportunities for development, job satisfaction and career planning with team members.
• Conduct check-in meetings with non-our Company's resources supporting the team about assignments and progress toward deliverables. Meet with partner line manager to discuss any relevant performance feedback.
• Ensure compliance to required training for all team members.

Accountable For Team Members

• Executing their role, with a focus on approving functional requirements, timely and quality completion of systems validation, implementation and operational activities; working with our Research & Development Division-IT and/or Vendor to prioritize enhancements and drive future roadmap to meet business needs.
• Working with our Research & Development Division-IT and vendors to establish secure and timely data flow from/to upstream/downstream systems and have monitoring in place as needed.
• Actively engaging in Platform and Information Governance teams as applicable.
• Ensuring adequate helpdesk support, case tracking and trending is in place to support business users for all applications in scope of the team.
• Performing business process impact assessments for new applications or enhancements to existing application and providing details to Business Process/Sub-process Owners to make necessary updates to the processes.
• Ensuring Inspection Readiness status, having and maintaining systems story boards, current BCP and SOPs and ongoing tracking of planned/completed system releases and Account reviews for applicable systems.
• Having ongoing collaboration with Regional Systems Business Leads and functional SMEs for optimum adoption and compliant use of applications.

Education

• BS degree with or above10 years' experience;

OR

• MS/MBA/JD degree with 8 years' experience; or PhD degree with 5 years' experience in Science, Clinical Research, Computer Science, or similar fields.

Experience And Skills

• 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 required.
• Ability to quickly gain thorough understanding and become subject matter expert in a new business area as needed, e.g. Risk Based Monitoring, Structured Content Authoring, clinical content standards.
• Strong verbal & written communication skills - able to present information confidentially and effectively to leadership, peers, and team.
• Ability to proficiently interact with all levels of management, exert influence to achieve results without authority and successfully manage senior/Executive level stakeholders.
• Project and Resource management experience.
• Deep knowledge and understanding of Clinical Trial processes as well as quality management and control tools.
• Experience with critical clinical systems such as CTMS, eTMF, Electronic Data Capture (EDC) system, clinical portal and basic reporting and MS Office tools.
• Understanding metrics and being able to identify trends.