Clinical Systems Implementation Team Lead

MSD•Rahway, PA

1d•Hybrid

About The Position

The Clinical Systems Implementation Team Lead within BEO manages activities related to the validation, implementation, and adoption of applications that support the company’s clinical trials. The systems may be internal or external, large or small, and vendor- or company-developed. The role also manages team members responsible for similar activities and requires relevant experience with the systems and processes supported by the team, or the ability to gain that experience after joining. The Team Lead partners with Global Clinical Development (GCD), Research & Development Division - IT, business stakeholders, and vendors to understand business needs, identify suitable solutions, and implement them with a focus on quality. The role ensures compliance with company policies, agency regulations, and related guidance, and applies data stewardship and governance principles. It is accountable for supporting system audits and inspections and managing follow-up findings and required CAPAs. The role ensures that the systems quality lead is engaged early in upgrades and re-platforming to support SDLC compliance, and that team members receive and maintain required SDLC training. As a member of the BEO Leadership Team, the Team Lead contributes to monthly department meeting agendas, proposes projects and assignments for interns, supports internship candidate identification, and schedules quarterly business reviews with other team leads to share accomplishments and upcoming activities. The role manages team members who own operational business systems, including resource allocation, hiring support when approved, performance management, development discussions, risk and escalation management, and compliance training. It ensures that systems are supported through quality requirements management, validation, implementation, operations, secure data flows, governance engagement, helpdesk support, process impact assessments, inspection readiness, current system documentation, release and account review tracking, and collaboration with regional systems leads and functional SMEs. The position is based primarily in North Wales, Pennsylvania, and is listed as hybrid with a first-shift schedule. Travel requirements are 10%. The position is regular employment, and relocation and visa sponsorship are not offered. The stated base salary range for the primary location is $173,200 to $272,600, with eligibility for an annual bonus and long-term incentive, if applicable. Benefits include medical, dental, vision, and other insurance benefits, retirement benefits including a 401(k), paid holidays, vacation, compassionate days, and sick days.

Requirements

BS degree with at least 10 years of experience; or MS, MBA, or JD degree with at least 8 years of experience; or PhD degree with at least 5 years of experience in Science, Clinical Research, Computer Science, or similar fields.
Two to five years of people management experience.
Broad understanding of drug development, including safety, clinical trials, trial design, data management, trial operations, regulatory matters, privacy, ICH, and GCP.
Ability to quickly gain a thorough understanding and become a subject matter expert in new business areas as needed.
Strong verbal and written communication skills, including the ability to present information effectively to leadership, peers, and teams.
Ability to interact proficiently with all levels of management, influence outcomes without authority, and manage senior and 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, electronic data capture (EDC) systems, and clinical portals, as well as basic reporting and MS Office tools.
Ability to understand metrics and identify trends.
Experience in system validation and implementation, systems analysis, and systems maintenance and support.
Fluency in cross-functional interdependencies, roles, and enabling tools and technologies.
Ability to identify critical process inputs and outputs and distinguish workflow dependencies from technology and data-flow dependencies.
Experience or exposure in a global environment with multicultural and organizational operating models, and appreciation of country requirements compared with US standards.
Management and leadership skills, analytical ability, good judgment, ability to multitask, conflict-resolution expertise, and discretion.
Customer-service orientation and ability to work effectively with clients, third-party vendors, quality teams, and IT management and staff.
Experience training a user community.
Required skills listed: 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, and Strategic Planning.

Responsibilities

Partner with cross-functional functional SMEs and end users to assess emerging business needs and work with Research & Development Division - IT to identify solutions.
Monitor technology trends, profile partners and vendors, and map capabilities to business requirements and the GCTO strategy.
Develop business cases for innovation opportunities and advance selected solutions from proof of concept through pilot and scaled implementation, ensuring due diligence and audit or inspection readiness where applicable.
Collaborate with user experience experts and gather early and ongoing user feedback to help ensure solutions provide an optimum user experience.
Work with business and IT sponsors to understand technology strategy and develop and drive technology and innovation roadmaps.
Identify and manage KPIs to measure outcomes and the success of technology solutions intended to improve clinical operations productivity and site and patient experiences.
Provide workstream or sub-stream leadership, or participate as a team member, on larger technology initiatives as needed.
Create change and communication plans to support technology adoption and share best practices and lessons learned.
Own assigned systems and related activities, which may include system migrations and decommissioning.
Manage team members responsible for business ownership of operational systems and allocate resources to maintain effective support.
Justify additional headcount when needed and, if approved, work with HR recruiters to identify, interview, and onboard candidates.
Conduct regular one-to-ones and ad hoc meetings, set and monitor priorities, provide constructive feedback, conduct performance reviews, and manage risks and escalations.
Understand team-supported applications sufficiently to identify challenges, address escalations, update sponsors, and provide backup during staffing challenges.
Discuss employee development, job satisfaction, and career planning with team members.
Check in with non-company resources supporting the team and meet with partner line managers to discuss relevant performance feedback.
Ensure required training is completed and maintained by team members, including training on SDLC requirements.
Ensure team members approve functional requirements and complete system validation, implementation, and operational activities in a timely and high-quality manner.
Ensure team members work with Research & Development Division - IT and vendors to prioritize enhancements and drive roadmaps that meet business needs.
Ensure secure, timely data flows between upstream and downstream systems and appropriate monitoring is in place.
Engage with Platform and Information Governance teams as applicable.
Ensure adequate helpdesk support, case tracking, and trending for business users of applications in the team’s scope.
Ensure business process impact assessments are performed for new applications and enhancements, and provide details to Business Process/Sub-process Owners for process updates.
Maintain inspection readiness, system storyboards, current BCPs and SOPs, and tracking of planned and completed releases and account reviews for applicable systems.
Collaborate with Regional Systems Business Leads and functional SMEs to support effective adoption and compliant use of applications.
Support system audits and inspections, follow up on findings, and manage required CAPAs.
Engage the systems quality lead early in technology upgrades and re-platforming to ensure appropriate SDLC compliance.
As a BEO Leadership Team member, identify monthly meeting topics and guest speakers, propose intern projects and assignments, support internship candidate identification, and schedule quarterly business review meetings with other team leads.