Sr. Clinical Project Manager

WorldCare Clinical, now Voiant, is seeking a Senior Clinical Project Manager to provide strategic operational leadership across a portfolio of clinical trials. The role includes managing complex studies, overseeing team performance, and driving process improvements within Clinical Operations.

Responsibilities:

• Oversees a portfolio of complex and strategically significant clinical studies across assigned service lines; ensures each study is delivered on time, within budget, and to the highest quality standards
• Develops and executes integrated project plans and other key documents for assigned studies; supports governance preparation and strategy in collaboration with Associate Directors and Directors
• Maintains accountability for the overall health of assigned projects; intervenes proactively when risks materialize and leads recovery planning as needed
• Serves as the escalation point for complex operational, sponsor, and cross-functional issues from study PMs on assigned studies; escalates unresolved or high-impact issues to Associate Directors and Directors as appropriate
• Manages a team of direct reports; provides ongoing coaching, mentorship, and performance feedback to support individual development and team effectiveness
• Conducts timely and substantive performance evaluations; develops and oversees individual development plans and manages time and attendance for direct reports
• Takes corrective action as needed; escalates performance concerns to Associate Directors, Directors and department head with appropriate documentation
• Assigns team members to projects considering staff skill sets, workload, and cross-service-line development opportunities; monitors workload balance and effects change when necessary to keep projects on track
• Assists in designing, implementing, and evaluating training programs that improve the overall performance and capability of Clinical Operations staff across assigned service lines; reviews and evaluates the cost and effectiveness of such programs; ensures all training materials are technically accurate, documentation is complete, and instructors are competent and prepared to deliver training in a professional manner
• Collaborates with senior management and the Head of Operations to standardize project management processes, tools, and best practices across assigned service lines and study types; develops and maintains departmental SOPs and Work Instructions to ensure all trial workflows conform to applicable regulatory standards
• Works with management to establish onboarding procedures for new hires; assists senior management with balancing and optimizing resources across clinical operations
• Maintains strong client relationships for assigned studies; supports sponsor communication and ensures a high standard of customer service throughout the engagement
• Assists Associate Directors and Directors in preparation for governance meetings, steering committees, and project review calls; prepares supporting materials including status updates, performance data, risk summaries, and forward-looking project plans
• Assists project managers in communications with clients when deliverables are at risk; escalates to Associate Directors and Directors when cross-project prioritization or VP-level involvement is required
• Oversees study vendor management, ensuring CROs, imaging vendors, labs, IRT providers, and adjudication committees meet contractual obligations and performance standards
• Ensures TMF completeness, inspection readiness, and compliance with all applicable SOPs, Work Instructions, and study-specific procedures across all assigned studies; consistently performs duties in accordance with current GxP standards and applicable regulations (e.g., Good Clinical Practices, Good Documentation Practice, 21 CFR Part 11/Annex 11, MHRA, GDPR, HIPAA)
• Leads or participates in internal and external audits and inspection-readiness activities; oversees CAPA development and implementation
• Assists BD and senior management with capability presentations, proposal development, RFP input, and project scoping; may present at bid defense meetings as a subject matter expert
• Supports management of departmental budget contributions; participates in financial activities including billing, forecasting, scope reviews, amendments, and change order management
• Contributes to departmental metrics development, review, and analysis; identifies trends and recommends operational improvements
• Assists with all other departmental requests as needed and upon request

Requirements:

• Bachelor's degree required or equivalent experience; degrees in life sciences, pharmacy, nursing, or a related healthcare field strongly preferred
• Minimum 5–10 years of progressive clinical trial experience within a CRO, pharmaceutical setting, or reading center; multi-service-line expertise highly desirable
• Minimum 2 years of people management or functional management experience; demonstrated ability to mentor, develop, and retain clinical operations talent
• Demonstrated project management abilities in clinical research, pharmaceuticals, or a related technical field required
• Strong understanding of the drug development process and applicable regulatory frameworks including ICH GCP, FDA 21 CFR, ICH E6(R2), MHRA, GDPR, and HIPAA
• Strong financial acumen: proven experience managing project budgets, forecasting, and change order processes
• Exceptional leadership, communication, and stakeholder management skills; demonstrated ability to influence at all levels of an organization
• Proven track record of driving process improvement, training program development, and operational standardization in a clinical operations environment
• Proficient in Microsoft Office Suite; advanced proficiency in project management and CTMS tools preferred
• High attention to detail and responsiveness to requests
• Valid passport and ability to travel approximately 10%
• Experience contributing to BD activities including RFP responses, scoping, and bid defense preferred
• ACRP-PM, PMP, or equivalent certification strongly preferred