Lead assigned clinical projects and programs across the full lifecycle: planning, execution, monitoring, reporting, stabilization and closure (or lifecycle management).
Apply established and evolving project management methodologies to streamline processes and improve consistency across the Clinical Affairs portfolio.
Develop, document, and implement project plans, budgets, timelines, resource forecasts, risk and mitigation plans, and communication plans.
Design and develop industry-leading quality control operating practices for project execution and deliverable acceptance.
Develop, implement and maintain systems and dashboards to monitor project, portfolio and organizational goals (e.g., milestones, key performance indicators, resource capacity, financial health), providing timely, accurate status reporting to appropriate stakeholders.
Drive and coordinate project-related activities such as process documentation, knowledge transfer, and cross-functional readiness.
Serve as primary contact for internal stakeholders and external partners for assigned projects; manage expectations and escalate issues appropriately.
Coach and train junior team members and onboard contractors, as applicable, on techniques, processes, responsibilities, and project tools to foster capability development and drive consistency of work.
Identify opportunities for process improvement, standardization, and automation across project and portfolio activities.
Present Clinical Affairs project and portfolio health summaries to senior leadership, as applicable.
Integrate Johnson & Johnson’s Credo and Leadership Imperatives into project planning, decision making, and team objectives.
Ensure adherence to applicable regulatory, ethical and compliance requirements in clinical programs (e.g., ALCOA+, GCP principles, documentation standards).
Responsible for communicating business-related issues or opportunities to next management level
Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
Responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

Requirements

Minimum of a Bachelor’s degree in Life Sciences, Nursing, Clinical Research, Engineering, Business, or related field required
Advanced degree (MS/MBA) or equivalent experience in clinical operations, clinical affairs, or related discipline highly desired
At least 5+ years of project management experience, with at least some experience in clinical, medical device, or regulated healthcare environments required
Experience with clinical trial operations, external research, post-market clinical studies and / or real-world evidence strongly preferred
Demonstrated ability to manage multiple, concurrent projects and interact with cross-functional clinical, regulatory, R&D, and commercial teams.
Strong working knowledge of project management principles and tools (e.g., scheduling, budgeting, risk management, stakeholder management).
Proven verbal and written communication skills with experience preparing and delivering status updates and executive-level summaries.
Strong problem solving skills with the ability to identify issues early, implement appropriate corrective actions, and escalate concerns effectively when needed
Ability to work independently with minimal supervision and to serve as a trusted point of contact for teams and internal / external stakeholders.
High proficiency with standard office and project management tools (e.g., MS Project, Excel, PowerPoint, Smartsheet, or comparable tools).
Project management certification (PMP, PMI-ACP, or equivalent) strongly preferred.
High knowledge of regulatory requirements for medical devices and clinical documentation standards preferred.
Strong demonstrated experience with portfolio management frameworks and tools preferred.
A minimum of 25% travel is required, domestic and global, may be required.

Benefits

Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Eligible for the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

project managementclinical trial operationsrisk managementbudgetingschedulingstakeholder managementportfolio managementprocess improvementquality controlregulatory compliance

Soft Skills

communicationproblem solvingleadershipcoachingindependencecross-functional collaborationexpectation managementtrainingprocess documentationknowledge transfer

Certifications

PMPPMI-ACP