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  • Clinical Project Manager - EU Zagreb
  • ProPharma in Zagreb, , Croatia
  • jobs
  • 1 week ago

jobs description

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Due to growth, we have an opportunity for an experienced Clinical Project Manager to join ProPharma in one of our Central Eastern European locations.

The Clinical Project Manager position is responsible for oversight... and conduct of clinical research trials. They will ensure that clinical trials are executed in accordance with applicable regulations and that the quality of clinical data generated from clinical trials meets the requirements for Regulatory Authority approval. This position provides strategic and tactical operational planning and execution of all phases of clinical programs.

Main Responsibilities
• Plan and manage assigned studies from start to close out while managing project timelines and project budget.
• Proactively anticipate and understand concerns/issues/delays in the project and develops risk assessment and contingency plans. Holds each functional area responsible for associated risk mitigation and management.
• Primary source of communication for the clinical project team as well as the cross functional project teams both internal and external stakeholders.
• Participate in project kick-off meetings, provide regular updates to client, and ensure maintenance of communication between team members and client.
• Monitor project budget vs. cost. Responsible for timely execution of change orders to ensure that the project margins are being met.
• Track and forecast budget, metrics, timelines progress for all project deliverables to enable better project decisions.
• Gather metrics from cross-functional areas in relation to project progress.
• Provide study-specific training for the assigned clinical operations staff as appropriate.
• Evaluate and identify resourcing needs and continuously monitor over life cycle of the study.
• Develop, analyze, and report study metrics to Sponsor per Project Plan and proactively identify and communicate any risks or concerns.
• Develop and maintain Study Project Plans including, but not limited to, site selection and monitoring plans, TMF management plan, payment plans, etc. Also responsible for creating, training and updating study specific tools and templates to be used throughout the course of the trial.
• Manage study drug product and non-drug site supplies (study materials/equipment/manuals), deliverable development, shipment, tracking accountability and resupply to sites as needed.
• Develop the agenda and manage the planning and execution of Investigator Meetings: meeting vendor contracting and management, coordinate development of meeting agenda, content development and delivery of operational (non-Clinical Science) presentations and training materials, manage meeting execution and documentation; ensure input from key stakeholders.
• Responsible for the development and presentation of slides and training materials for various audiences.
• Assist with vendor selection (ECG, Lab, IWRS, IRB, Raters) and contracting for assigned studies.
• Ensure clinical study team compliance with applicable FDA / ex-US regulations, ICH-GCPs, other local regulatory requirements and corporate SOPs.
• Develop subject recruitment/retention strategy and related initiatives for assigned studies.
• Collaborate and communicate with other functional areas to identify and evaluate fundamental issues on study related projects.
• Lead and/or participate in investigator, client, and cross-functional team meetings.
• Oversee maintenance and quality review of study TMF.
• Develop and maintain tools for management of study deliverables (i.e., timelines, study plans, adherence to monitoring plan and TMF plan, etc.).

Necessary Skills & Abilities
• Excellent verbal, written communication skills and interpersonal and presentation skills are required.
• Experience with IVRS and EDC systems a must.
• Knowledge of FDA and/or ex-US Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.
• Ability to develop tools and processes that increase measured efficiencies of the project.
• Experience managing/mentoring and developing junior staff.
• Demonstrated experience in change management initiatives.

Educational Requirements
• Bachelor’s degree or advanced degree (e.g., Master, PharmD, PhD) preferred. Candidates with equivalent combination of education, training, and experience will be considered.

Experience Requirements
• At least 5 years of clinical trial and research experience.
• CNS, Rare Disease and Paeds experience is preferable.

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
• **ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting
Zagreb Croatia

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