Job Summary
The Clinical Project Manager II provides independent, end-to-end project management across assigned clinical studies within one or more Voiant service lines, including Medical Imaging (IMG), Endpoint Adjudication Committees (EAC), and Ophthalmology (OPH). Operating with a high degree of autonomy, the CPM II is accountable for the delivery, quality, and client experience across a complex and varied study portfolio. This role serves as a step below Sr. CPM and is expected to demonstrate the leadership behaviors, cross-functional ownership, and operational depth required for advancement to that level.
Responsibilities
· Independently manages a portfolio of clinical studies across assigned service lines (IMG, EAC, and/or OPH) from startup through closeout; accountable for on-time, on-budget delivery and the highest standards of quality and sponsor satisfaction.
· Develops and executes integrated project plans, imaging charters, and study-specific documents; leads cross-functional teams across service line functions including imaging, reading center operations, data management, EAC coordination, and regulatory affairs as applicable.
· Serves as the primary internal and external point of contact for assigned studies; independently manages sponsor communication, chairs project calls, and navigates complex or difficult sponsor conversations without routine escalation to the Associate Director.
· Serves as an informal mentor and resource to CPM I staff; provides day-to-day guidance on study execution, escalation decisions, and sponsor communication; supports onboarding of junior team members within assigned service lines.
· Proactively identifies study risks across operational, sponsor, timeline, and quality dimensions; develops and implements mitigation plans independently and escalates appropriately to the Associate Director when cross-project prioritization or senior intervention is required.
· Monitors and reports on study-level KPIs and deliverable status; contributes to departmental metrics development and analysis; identifies trends and recommends operational improvements within assigned service lines.
· Leads UAT and build specification reviews across assigned studies, including complex multi-service-line and multi-sponsor builds; coordinates cross-functional input, manages review cycles, documents outcomes, and drives resolution of issues to closure; accountable for ensuring all system builds meet study requirements prior to go-live; escalates critical issues to the Associate Director immediately when go-live timelines or study integrity are at risk
· Participates in governance and steering committee meetings; contributes to sponsor-facing status updates, risk summaries, and performance data packs under Sr. CPM or Associate Director direction.
· Contributes to the development and review of departmental SOPs and Work Instructions; proactively identifies and flags process gaps or inefficiencies to the Associate Director or Sr. CPM for review; may lead a focused training module or onboarding segment within an assigned service line under Sr. CPM or Associate Director guidance.
· Participates in internal and external project-related audits for assigned studies; serves as the study-level point of contact for audit documentation requests; prepares study files for audit readiness and follows up on audit findings under Associate Director guidance.
· Maintains thorough knowledge and understanding of client contracts, deliverables, business practices, and key performance indicators, including all key client agreements such as Service Level Agreements, Governance Agreements, and Rate Cards.
· Consistently performs all duties in accordance with established Policies, SOPs, Work Instructions, and Study-Specific Procedures and applicable regulations including GCP, Good Documentation Practice, 21 CFR Part 11/Annex 11, MHRA, GDPR, and HIPAA.
· Manages financial performance of assigned studies including monthly billing, revenue forecasting, scope reviews, change order identification and management, and budget variance tracking; escalates out-of-scope activity proactively to the Associate Director.
Qualifications
· Bachelor's degree in life sciences, nursing, pharmacy, business, or a related field required; equivalent combination of education and experience considered.
· Minimum 3–5 years of progressive clinical trial experience within a CRO, imaging core lab, or pharmaceutical setting, with demonstrated growth from CPM I or equivalent; prior independent management of a study from startup through closeout required.
· Demonstrated ability to manage a complex, multi-study portfolio independently with minimal day-to-day oversight; proactively identifies issues and drives resolution without requiring managerial direction.
· Strong working knowledge of applicable regulatory frameworks including ICH GCP, FDA 21 CFR Part 11/Annex 11, ICH E6(R2), MHRA, GDPR, and HIPAA; familiarity with imaging-specific and EAC-specific regulatory requirements a plus.
· Experience in one or more Voiant service lines strongly preferred: medical imaging (IMG), endpoint adjudication committees (EAC), or ophthalmology (OPH); cross-service-line exposure highly desirable.
· Proficient in Microsoft Word, Excel, and PowerPoint; experience with project management or CTMS platforms required; proficiency in Voiant Hub and/or familiarity with OEM systems and platforms commonly used in clinical trial management strongly preferred
· Strong written, verbal, and interpersonal communication skills; demonstrated ability to manage sponsor relationships independently, including complex or difficult conversations.
· Ability to manage multiple priorities and competing deadlines across a complex portfolio while maintaining accuracy and attention to detail.
· Working knowledge of project financial processes including monthly billing, forecasting, scope reviews, and change order management; demonstrated proficiency expected at this level.
· Flexibility to accommodate hours outside of typical business hours as study needs require; occasional travel may be required.
· PMP, ACRP-PM, or equivalent certification preferred; active pursuit expected at this level.
Pay: $75,000.00 - $85,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee discount
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Professional development assistance
- Referral program
- Tuition reimbursement
- Vision insurance
Application Question(s):
- It is preferred that the candidate has previous experience with Ophthalmology, Medical Device, Pharmaceutical or the Clinical Research Industry and with regulations & standards such as GCP, FDA 21 CFR 320 and 812.
How many years of experience do you have?
- What types of projects have you managed in the past?
What was the outcome?
- Have you participated as an SME on audits and inspections?
If yes, please elaborate on your role supporting the audit/inspection
- Do you have experience in reviewing study budgets – forecasting and reconciliation, and how the scope of work translates to operational deliverables for a study?
- Are you authorized to work in the U.S without employer sponsorship assistance?
Work Location: Remote
