Project Manager II (Romania)
WFA Digital Insight
The demand for experienced project managers in the clinical research sector continues to grow, with a notable 25% increase in job postings over the past year. As the industry shifts towards more complex and global trials, professionals with expertise in managing multi-centered studies are in high demand. Indero, a mid-sized CRO, offers a unique environment where professionals can grow their careers alongside the company. With a focus on dermatology and rheumatology trials, this role requires strong leadership and organizational skills. Before applying, candidates should be aware of the importance of staying up-to-date with industry developments and regulations, as well as the need for effective communication and collaboration in a remote setting.
Job Description
About the Role
The Project Manager II position at Indero is a critical role that oversees the successful execution of clinical trials from initiation to closure. This involves managing cross-functional teams, coordinating study resources, and ensuring compliance with regulatory requirements and standard operating procedures. The ideal candidate will have a strong background in clinical research, with experience in managing Phase I-III trials and a proven track record of delivering results in a fast-paced environment.As a Project Manager II, you will be responsible for leading client interactions, providing updates on trial progress, and ensuring that all stakeholders are informed and aligned. You will also oversee the preparation of project deliverables, such as study plans, protocols, and clinical study reports. Your ability to manage multiple priorities, lead teams, and drive results will be essential in this role.
Indero is a mid-sized CRO that specializes in managing significant multi-site trials, including Global Phase III projects. The company offers a dynamic and supportive environment where professionals can grow their careers and develop their skills.
What You Will Do
- Serve as the primary contact for sponsors and provide efficient and timely updates on trial progress
- Lead client calls and ensure that all stakeholders are informed and aligned
- Oversee the preparation of project deliverables, such as study plans, protocols, and clinical study reports
- Participate in the planning and conduct of Investigator’s Meetings
- Ensure that each site has the necessary materials to perform the study
- Lead study start-up activities, including trial kick-off, TMF setup, site selection, and activation
- Collaborate with Regulatory Affairs to ensure timely submissions and completeness of essential documents
- Partner with Data Management to ensure CRF alignment with protocol and sponsor requirements
- Manage risk and control measures to assure project quality
- Analyze discrepancies between planned and actual results
- Review and approve responses to quality assurance audits
- Control the project budget and identify out-of-scope activities for change orders
- Proactively manage operational aspects of the clinical trial, including trial timelines, budget, resources, and vendors
What We Are Looking For
- B.Sc. in a related field of study to clinical research
- At least 5 years of industry experience, with a minimum of 3 years in Phase I-III clinical trial project management
- Experience managing dermatology and/or rheumatology trials
- Experience leading concurrent multi-centered clinical trials with budgets
- Strong leadership and organizational skills
- Ability to manage multiple priorities and lead teams
- Excellent communication and collaboration skills
- Experience with Excel and other project management tools
- Knowledge of regulatory requirements and standard operating procedures
Nice to Have
- Experience with electronic data capture systems
- Knowledge of data management and biostatistics
- Experience with quality assurance and audit processes
- Certification in project management or clinical research
Benefits and Perks
- Competitive salary and benefits package
- Opportunity to work with a dynamic and supportive team
- Professional development and growth opportunities
- Flexible working hours and remote work options
- Access to cutting-edge technology and tools
- Comprehensive health insurance and retirement plan
- Paid time off and holidays
How to Stand Out
- Ensure your resume and cover letter are tailored to the specific requirements of the job, highlighting your experience in clinical research and project management.
- Develop a strong understanding of the company and the role, and be prepared to ask informed questions during the interview process.
- Showcase your leadership and organizational skills by providing specific examples of your experience in managing cross-functional teams and coordinating complex projects.
- Familiarize yourself with industry developments and regulations, and be prepared to discuss your knowledge and experience in these areas.
- Prepare to discuss your experience with project management tools, such as Excel, and your ability to manage multiple priorities and lead teams.
- Be prepared to provide examples of your experience in managing budgets, timelines, and resources, and your ability to proactively manage operational aspects of clinical trials.
- Consider creating a portfolio or examples of your work to demonstrate your skills and experience to potential employers.
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