About the Role
Early Phase Project Manager responsible for the development, conduct, and completion of research projects in accordance with the reasonable requirements of the originator, including study management activities such as cross‐functional team leadership and coordination, client communication, financial management, and overall study delivery. Must ensure effective resourcing, efficient management, and adherence to Good Clinical Practice (GCP), regulatory requirements, and standard operating procedures (SOP). Mentor and coach junior staff, and work independently or with support from portfolio delivery leads.
Responsibilities
All activities must be conducted in accordance with project‐specific documentation, applicable SOPs, ICH GCP, and regulatory requirements.
* Maintain professional relationships with external customers, investigators, vendors, and internal project team members.
* Provide clear guidance to the project team on deliverables.
Project Kick‐off
* Attend relevant project‐specific meetings, including formal kick‐off meetings.
* Develop project plan and other internal project management documents.
* Assist the originator in developing protocol and participant information forms as requested.
* Coordinate feasibility planning and selection of project sites.
* Identify activities to outsource and participate in vendor selection.
Project Implementation and Closure
* Contribute to project budget preparation where applicable.
* Track budget and scope; propose changes when necessary.
* Oversee site feasibility, set‐up, and training according to SOPs and regulatory guidelines.
* Monitor progress, deliver milestones, and coordinate project administration (e.g., committee meetings, newsletters).
* Ensure patient safety, reporting of adverse events, and proper filing and archiving of data.
* Coordinate with data management and statistics to support data integrity and quality.
* Provide progress reports to originator and stakeholders.
* Maintain regular contact with national coordinators and be available as a backup contact for site staff.
Study Start‐up
* Coordinate feasibility and selection of all centers.
* Ensure each center has necessary materials, contracts, and trained staff.
* Develop trial management systems, monitoring plans, and investigator meetings.
Study Close‐out
* Ensure timely completion of trial and coordinate close‐out visits.
* Reconcile clinical supplies and ensure complete documentation.
* Coordinate final archiving of study documents.
Data Management
* Ensure accurate and timely data collection, quality, and resolution of queries.
* Adhere to protocol, SOPs, regulations, and ICH‐GCP.
* Manage distribution of essential documents and reports to sites.
Financial and Contractual
* Analyze monthly financial reports for trends and issues.
* Ensure correct project financial responsibilities and escalation pathways.
* Maintain project utilization, revenue forecast, and gross margin.
* Review forecasts and develop contingency plans for project slippage.
* Manage pass‐through reports and billing timelines.
* Maintain documentation of scope changes and collaborate with proposal teams on pricing.
Customer Focus and Business Development
* Build and maintain relationships with stakeholders including sponsors, key opinion leaders, hospitals, and professional societies.
* Contribute to scope change proposals and participate in bid defense presentations.
Quality Management
* Ensure projects align with Emerald Clinical's quality management strategy.
* Prepare for audits and inspections, ensuring readiness of team members.
* Maintain file review plans and co‐monitoring activities as required.
About You
* Bachelor's or master's degree in science or related field.
* Previous experience on clinical projects in academic, CRO, or pharmaceutical environments.
* Approximately seven (7) years of industry experience, with 1–2 years of project management experience.
* Prior CRA experience preferred; experience in trial coordination or equivalent role.
* Experience managing early‐phase and healthy volunteer studies is a plus.
* Experience managing studies across multiple regions and therapeutic indications.
* Strong knowledge of ICH GCP and applicable regulations in relevant regions.
* Client‐facing interaction and client management exposure.
* Project finance management experience.
* Excellent interpersonal, presentation, and team leadership skills, including virtual and cross‐cultural environments.
* Strong written and verbal communication skills.
Why Join Us?
* Purpose‐driven work: contribute to trials that improve lives in renal, cardiometabolic, and oncology areas.
* Global reach with local expertise: collaborate with diverse teams and build community trust.
* Collaboration and innovation: a culture that values innovation and diverse perspectives.
What We Offer
* Competitive compensation tailored to your skills and experience.
* Flexibility: hybrid or remote work arrangements depending on location and role.
* Career growth: learning opportunities and a global network of scientific leaders.
* Employee wellbeing: health, work‐life balance initiatives, recognition, and team‐building events.
* Global opportunities: exposure to diverse projects and clients.
* We are an equal‐opportunity employer and encourage applications from all qualified candidates.
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