Job Description
Job Title: Clinical Research Project Manager – CRO Liaison
Department: Research and Development
Reports to: CEO & Chief Scientific Officer Level
Position Overview
Pierian Bioscience is a personalized medicine company developing innovative diagnostic assays guiding physicians to improve cancer patient outcomes. The Clinical Research Project Manager (CRPM) serves as the primary liaison between R&D and CROs for multi-country clinical trials (UK, Greece, Poland, and Serbia), reporting to the CEO and collaborating closely with the Chief Scientific Officer. The role is focused on day-to-day operational management, milestone tracking, and ensuring the highest quality standards to support pivotal trials for Pierian’s novel medical devices and diagnostic platforms.
Essential Job Functions
- Primary operational point of contact with CROs and internal teams for coordinated logistics, scheduling, site activation, and communications.
- Lead and monitor study progress against project plans—track milestones, deliverables, decisions, and maintain rigorous documentation for audits and management review.
- Manage trial start-up (site selection, contracts, import permits, regulatory submissions); maintain updated forward plans for site-by-site go-live and patient recruitment.
- Establish assertive, proactive weekly reporting processes: updates provided in advance, focused meetings on issues, new actions tracked, minutes circulated promptly.
- Review CRO activity, reports, and feedback (status, monitoring, adverse events, inventory); escalate problems rapidly, champion corrective measures, and support risk forecasting and mitigation.
- Oversee compliance with study protocol, GCP, ISO 14155, ICH, and all relevant European regulations in each country.
- Motivate and support surgical/oncology teams in the UK/EU through training, recognition, feedback, and stakeholder communications—personally contribute to problem solving and team engagement.
- Monitor participant recruitment, screening, enrolment progress (using detailed metrics), and take action to address site-level enrolment challenges.
- Ensure resource allocation across staff, equipment, supplies, and troubleshoot operational challenges – address site contract/procedure irritations with PMs and CRAs.
- Oversee data accuracy, completeness, and timely reporting, support central data management processes and regulatory submissions.
- Liaise with investigators, regulatory bodies, and stakeholders; maintain high-quality documentation; prepare updates for senior management, stakeholders, and board reporting.
- Continuously identify, escalate, and mitigate risks to trial integrity and participant safety.
- Collaborate cross-functionally with internal regulatory, clinical, quality, and device development partners; support strategic planning for future Pierian studies and validation trials.
Technical Experience/Requirements:
- Minimum 3+ years hands-on clinical trial project management for multi-site/multi-national studies, preferably in diagnostics or medical devices.
- Direct operational experience with CROs and site management, including start-up, enrolment, and data reporting.
- Strong command of GCP, ICH, ISO 14155, and European regulatory standards for medical devices and diagnostics.
- Excellent organizational, problem-solving, communication, and interpersonal skills; proficiency in relevant trial/data management software systems.
- English fluency required; additional European languages are an asset. Willingness to travel in Europe as needed.
Education/Experience Requirements
- Bachelor’s degree in life sciences, biomedical engineering, nursing, or equivalent; advanced degree preferred.
Knowledge, Skills, and Abilities (KSAs)
- Methodical planning, execution, and troubleshooting of clinical trial operations.
- Assertive project/supplier management, with ability to escalate and resolve complex issues.
- Detail orientation, adaptability, and proven success working in international/regional clinical workflows.
- Experience leading teams, motivating stakeholders, and building strong collaborative relationships.
NOTE: This job description is not intended to be all-inclusive. Employees may perform other related duties as requested to meet the ongoing needs of the organization. Pierian Biosciences is an Equal Opportunity Employer with a strong commitment to the achievement of excellence and diversity.
To apply please forward your CV and Cover Letter to GeneralAttendant@pierianbio.com, your subject line should read ‘Clinical Research Project Manager/CRO Liaison Application – (Your Full Name)’
