Clinical Systems Implementation Team Lead

Merck & Co.; Rahway (NJ); Hybrid; USD 173,000 - 273,000; Full time

Benefits offered by this job

Hybrid work

Job summary

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.

Responsibilities

• 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.

Skills

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

Education

BS degree + 10 years exp

MS/MBA/JD + 8 years exp

PhD + 5 years exp

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. 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.

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;
• 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.
• Experience in System Validation and Implementation, systems analysis and systems maintenance /support.
• Fluency with the respective cross-functional interdependencies, roles and enabling tools/technologies.
• Able to identify critical input and outputs that drive business processes and dependencies on process (workflow) vs. technology (dataflow).
• Exposure to a global environment, with multi-cultural and organizational operating models; appreciation for country requirements/needs vs. US standards.
• Management and leadership skills, analytical ability, good judgment, ability to multi-task, conflict resolution expertise and discretion.
• Customer service orientation and the ability to work effectively with clients, third party vendors, quality and IT management/staff.
• Experience in training user community.

Required Skills

Adaptability, Benchmarking, Business Process Re-Engineering (BPR), Clinical Systems Implementation, Cross-Functional Teamwork, Data Analysis Tools, Decision Making, Good Manufacturing Practices (GMP), Innovation, IT Implementation, People Leadership, Professional Integrity, Quality Control Management, Risk Management, Strategic Planning

Preferred Skills

Adaptability, Benchmarking, Business Process Re-Engineering (BPR), Clinical Systems Implementation, Cross-Functional Teamwork, Data Analysis Tools, Decision Making, Good Manufacturing Practices (GMP), Innovation, IT Implementation, People Leadership, Professional Integrity, Quality Control Management, Risk Management, Strategic Planning

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.

For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

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The primary location for this posting is: USA - Pennsylvania - North Wales (Upper Gwynedd)

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is: $173,200.00 - $272,600.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

Additional location(s)

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information

San Francisco Residents Only

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Employee Status: Regular

Relocation: No relocation

VISA Sponsorship: No

Travel Requirements: 10%

Flexible Work Arrangements: Hybrid

Shift: 1st - Day

Valid Driving License: No

Hazardous Material(s): N/A

Job Posting End Date: 10/30/2026

A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.