Sr. Clinical Project Manager

Job Description:

The Senior Clinical Project Manager provides strategic operational leadership across a portfolio of clinical trials spanning assigned service lines. In addition to managing complex studies, the Sr. CPM is accountable for people management of direct reports, development, and delivery of training programs, and driving process standardization and departmental improvement across Clinical Operations. This role serves as a subject matter expert and senior operational resource, supporting organizational growth, consistency, and quality across assigned service lines. Reporting structure reflects portfolio complexity and organizational assignment.

Responsibilities & Accountabilities:

• 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.

Education & Experience:

• 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.
• Experience contributing to BD activities including RFP responses, scoping, and bid defense preferred.
• 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%.
• ACRP-PM, PMP, or equivalent certification strongly preferred.

Benefits:

• Competitive salaries
• Flexible work schedules 
• Comprehensive health, vision, and dental insurance (FSA/HAS)
• EAP, Health Advocates, and Ancillary Benefits available 
• Generous paid time off and holiday
• 401(K) with employer matching plan
• Annual Incentive Plan (AIP)
• Paid employer life insurance, a voluntary life and disability insurance
• Tuition Reimbursement 
• Ongoing training and development
• Internet allowance for remote workers  
• Company on site meals and stocked snacks
• Corporate Perks Program 
• Community Service Opportunities

Candidates can send their CV to hr@voiantclinical.com. Please feel free to reach out to HR Talent & Culture with any questions.