DESCRIPTION

Clinical Project Manager I provides project management support across assigned clinical studies within one or more Voiant service lines, including Medical Imaging (IMG), Endpoint Adjudication Committees (EAC), and Ophthalmology (OPH). Operating under regular guidance from the Associate Director or Sr. CPM, the CPM I is accountable for executing study deliverables, maintaining cross-functional coordination, and developing toward increasingly independent study management. This role serves as the entry point to the Clinical Delivery career track and is expected to build foundational competency across Voiant systems, sponsor communication, and regulatory standards.

RESPONSIBILITIES & ACCOUNTABILITIES

· Manages an assigned portfolio of clinical studies under regular guidance from the Associate Director or designee, developing toward increasingly independent study execution as experience and competency grow.

· Develops, maintains, and manages all study-specific documentation and deliverables applicable to assigned studies, including study execution plans, data review plans, imaging charters, timelines, and status reports; may consult with the Associate Director or designee for guidance as needed.

· Serves as the primary internal and external point of contact for assigned studies; leads cross-functional study teams in executing against protocol requirements, project timelines, and quality standards; escalates issues and risks to the Associate Director or designee in a timely manner.

· Proactively identifies potential study risks and contributes to the development and implementation of mitigation actions; communicates findings to the Associate Director or designee and relevant internal stakeholders.

· Supports user acceptance testing (UAT) and build specification reviews for applicable systems and platforms used in assigned studies; documents findings and escalates issues to the Associate Director or designee and relevant internal teams as needed.

· Escalates complex operational, sponsor-facing, or cross-functional issues to the Associate Director and/or department head in a timely manner.

· Maintains working knowledge of assigned client contracts, deliverables, key performance indicators, and key client agreements including Service Level Agreements, Governance Agreements, and Rate Cards.

· Consistently performs all duties in accordance with established Policies, SOPs, Work Instructions, Study-Specific Procedures, and applicable regulations including GCP, Good Documentation Practice, 21 CFR Part 11/Annex 11, MHRA, GDPR, and HIPAA; raises observed gaps or inconsistencies to the Associate Director or designee for review.

· Participates in financial tasks including monthly billing, forecasting, scope reviews, and amendments under the guidance of the Associate Director.

· Participates in internal and external project-related audits in a supporting capacity; provides study documentation and responds to auditor queries as directed by the Associate Director or Sr. CPM.

· Assists with all other departmental requests as needed.

EDUCATION & EXPERIENCE

· Bachelor's degree in life sciences, nursing, pharmacy, business, or a related field preferred; equivalent combination of education and experience considered.

· Minimum 3 years of clinical trial experience within a CRO, pharmaceutical, or reading center environment, with at least 1 year of that experience in a project management or project coordination role.

· Working knowledge of GCP and applicable regulatory frameworks including FDA 21 CFR, GDPR, and HIPAA; familiarity with additional regulatory standards developed on the job.

· Familiarity with CTMS platforms and clinical data management systems preferred; Voiant-specific systems training provided during onboarding.

· Medical imaging knowledge or experience a plus.

· Proficient in Microsoft Word, Excel, and PowerPoint; experience with project management or CTMS platforms preferred.

· Strong written and verbal communication skills; demonstrated ability to work effectively within a cross-functional team environment, collaborating with internal stakeholders and external sponsors in a professional manner.

· Ability to manage multiple priorities and competing deadlines while maintaining accuracy and attention to detail.

· Comfortable working in a structured, process-driven environment with regular manager guidance; flexibility to accommodate hours outside of typical business hours as study needs require.

· Basic understanding of project financial processes including monthly billing and forecasting; willingness to develop proficiency in these areas as part of the role.

· Valid driver's license required; occasional travel may be required as study needs dictate.

· Project management certification (PMP, ACRP-PM, or equivalent) not required but encouraged as part of professional development.

Job Type: Full-time

Pay: 65.000,00€ - 68.000,00€ per year

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 are some of the tools/applications you have used in your role as project manager to support study management, study timelines etc.

Do you have experience with tools/applications supporting CTMS and TMF maintenance?

• 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?

Work Location: Remote