About The Role
The Project Manager is responsible for the development, conduct, and completion of research projects in accordance with the requirements of the originator of the project, ensuring studies are resourced effectively, managed efficiently, and delivered within allocated budgets and agreed timelines. The role covers all aspects of study management activities, including cross‐functional team leadership, client communication, financial management, and overall study delivery. The Project Manager also mentors and coaches junior staff or Clinical Delivery Leads, and may work independently or with support from Portfolio Delivery Leads or Line Manager.
Responsibilities
Project Kick‐off
* Attend relevant project‐specific and formal kick‐off meetings.
* Develop project plans and internal project management documents.
* Assist the originator in developing protocol and participant information forms.
* Coordinate feasibility planning and site selection.
* Identify project activities that require outsourcing and involve vendor selection.
Project Implementation and Closure
* Prepare and manage project‐specific budgets, track financials, and forecast invoicing.
* Track project scope, propose changes, and coordinate with relevant personnel.
* Identify and select clinical sites, oversee feasibility, and conduct site visits.
* Supervise site setup according to SOPs, protocol, and regulatory guidelines.
* Calculate staffing levels, source materials, and monitor project progress.
* Deliver milestones, coordinate project administration, and drive team compliance with deadlines.
* Maintain contact with centre staff, National Coordinators, and data management/statistics teams.
* Lead quality control of data, ensuring clean, accurate, verifiable data for analyses.
* Sign off monitoring visit reports and ensure patient safety and adverse event reporting.
* File, archive, and maintain project deliverables, and provide progress reports to stakeholders.
* Ensure back‐up contact for site staff and liaise as needed with other departments.
Study Start‐up
* Coordinate feasibility planning and site selection for all centers.
* Manage establishment of study centers, ensuring trial materials, contracts, and agreements are in place.
* Equip site research coordinators and train staff on data management tools.
* Submit ethics and regulatory applications in a timely manner.
* Develop trial management systems and monitoring plans.
* Plan and conduct investigator meetings, preparing and presenting materials.
Study Close‐out
* Ensure timely and successful completion of the trial, including final reconciliation of supplies.
* Coordinate close‐out visits and archive all study documents.
Data Management
* Ensure accurate, timely collection of data and resolve data queries efficiently.
* Maintain compliance with protocol, SOPs, regulations, and ICH‐GCP.
* Distribute essential documents and reports to clinical sites.
* Analyze monthly financial reports, identify trends, and manage escalation.
* Maintain project utilization, revenue forecast, and gross margin goals.
* Review forecasts, manage pass‐through reports, and oversee billing within timelines.
* Update pricing tools, collaborate on scope changes, and seek expansion opportunities.
Customer Focus and Business Development
* Maintain high‐level relationships with internal and external stakeholders, including sponsors and key opinion leaders.
* Contribute to scope change proposals and participate in bid defense presentations.
* Lead presentations for smaller regional studies.
Quality Management
* Ensure projects conform to the Emerald Clinical Quality Management Strategy.
* Facilitate audit and inspection readiness, complete follow‐up, and maintain documentation.
* Ensure compliance with file review plans and monitoring activities per sponsor requirements.
* Maintain quality control of all relevant processes and activities.
About You
* Bachelor's or Master's degree in a science or related field.
* Experience working on clinical projects within an academic, CRO, or pharmaceutical environment.
* Approximately seven (7) years of industry experience, with 2‐3 years of project management experience.
* Prior CRA experience or site management role preferred; full‐service study management and phase 2‐3 trials in Renal domain mandatory.
* Strong knowledge and ability to implement project activities in accordance with ICH/GCP and regional regulations.
* Client‐facing and client‐management exposure.
* Project finance management experience.
* Excellent interpersonal, presentation, and team leadership skills; experience leading virtual teams in a cross‐cultural environment.
* Strong written and verbal communication skills.
Benefits
* Competitive compensation and tailored benefits package.
* Hybrid or remote working arrangements, depending on location and role.
* Career growth opportunities and access to global learning resources.
* Employee wellbeing programs, team‐building events, and engagement surveys.
* Global opportunities for exposure to diverse projects and clients.
We are an equal‐opportunity employer and encourage applications from all qualified candidates.
#J-18808-Ljbffr