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Clinical Project Manager Ii (europe), Czech Republic

Czech Republic, Czech Republic, Czech Republic
Publikováno 2023-11-20
Vyprší 2023-11-28
ID #1930835189
Clinical Project Manager Ii (europe), Czech Republic
Czech Republic, Czech Republic, Czech Republic,
Publikováno November 20, 2023


Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. At Allucent, our mission is to help bring new therapies to light.When you work at Allucent, that means rolling up your sleeves and applying your scientific knowledge, clinical expertise, and experience to partnerships with our clients in small and mid-sized biotech companies. These customers have new therapeutic ideas but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in patients’ lives. We are currently recruiting for a Project Manager II to join our team in Europe with the option to work hybrid/remote. The Project Manager (PMII) is responsible for the overall coordination and management of clinical trials from start up through to final delivery. This position directs the technical and operational aspects of clinical projects - all with the sense of urgency expected of Allucent customers. Candidate must have oncology experience; preference for early phase oncology, along with immune-oncology and/or cell therapy. Location: Europe (preference for Central/Eastern Europe) Experience: 2+ years in Global Clinical Project Management in a CRO Therapeutic Area: Cell/Gene Therapy and/or CNS Responsibilities Leads the project team, ensuring the project is delivered according to planned scope and timelines in accordance with the contract Creates and executes project management plans required for project delivery and in accordance with established processes Ensures quality and adherence to the relevant policies, SOPs, and working instructions, GCP and regulatory guidelines. Establishes clear communication lines and escalation pathways, communicates with project stakeholders Provides input on study related documents such as the study protocol, CRF, Medical Review/Monitoring plan, and Clinical Study Report Establishes requirements for and ensures project specific training plan for team activities Leads internal and external meetings, with internal and sponsor teams, including Kick Off Meetings (KOM) and Investigator Meetings based on project scope Provides support for vendor identification, qualification and selection and manage vendors Manages vendors and vendor relationships as required for project delivery Ensures effective and efficient resource utilization across projects and programs Produces, maintains and circulates project progress and status reports Manages the study budget, including monthly invoicing. Establishes project risk management plan with input from client and functional stakeholders and oversees adherence and updates throughout the project lifecycle Proactively recognizes and addresses any changes in scope Negotiates and influences internal and external team members in a professional manner and with successful outcomes Conducts review of initiation, monitoring and close-out visit reports May perform co-monitoring visits Ensures the Trial Master File is kept up to date and inspection ready Client management: Serves as the primary point of communication between the sponsor and project team Leadership: Leads by example and encourages team members to develop strong solutions for clinical trial delivery Responsible for oversight of project team delivery and communication with functional managers, including performance feedback May be assigned as line manager Requirements Minimum Bachelor’s degree in life science, healthcare and/or business degree Minimum 5 years of relevant work experience Minimum 5 years of experience in drug development and/or clinical research, with at least 2 years of clinical trial project management experience Preference for candidates with CRA experience Expert knowledge of ICH-GCP(R2), data and patient privacy practices, and applicable (local) regulatory requirements Demonstrates sound financial acumen, administrative excellence and strong analytical skills Excellent written and verbal communication, planning, critical thinking and organizational skills, including command of English language Representative, outgoing and client focused Ability to work effectively in a fast-paced challenging environment with a growing company Proficiency with various applications including, but not limited to, Microsoft Word, Excel, and PowerPoint required Strong presentation skills Fosters learning and the advancement and development of others Dependable and able to take action to quickly to address urgent needs Proactive and solution oriented Willingly takes ownership and drives positive, collaborative results with the project team Exercises good judgement with defined procedures and policies to determine appropriate action Benefits Comprehensive benefits package Competitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Opportunity for hybrid/remote working Improved work-life balance Internal growth opportunities and career progression More task variety Financially rewarding internal employee referral program Access to online soft-skills and technical training via GoodHabitz and internal platforms To all recruitment agencies: Allucent does not accept agency resumes. Please do not forward resumes to our careers alias or other Allucent employees. Allucent is not responsible for any fees related to unsolicited resumes #LI-AH1

Podrobnosti o práci

Typ práce: Plný úvazek
Typ smlouvy: Trvalý
Typ platu: Měsíční
obsazení: Clinical project manager ii (europe)

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