Sr. Manager / Manager Clinical Trial Project Management

Discover your potential with CliniRx today As an emerging Contract Research Organization (CRO) we aim to be at the forefront of innovation through cutting-edge research and development. Guided by the enduring business philosophy and 125-year legacy of our parent company the JK Group, CliniRx is committed to delivering exceptional services to biopharma companies seeking support for their clinical development initiatives. What we Offer At CliniRx, we prioritize your well-being and professional growth. Our compensation and benefits packages are tailored to match your talent and industry standards, ensuring your efforts are duly rewarded. You’ll find challenging career opportunities where success is met with corresponding rewards. We provide a supportive platform for every team member to thrive, encouraging innovation and creativity to deliver top-notch results and elevate quality standards. And remember, while we work diligently, we also believe in enjoying life’s moments, breaking the monotony with moments of fun, because happiness and cheer are integral to our culture. Department:Clinical Operations No. of Positions: 2 United States:California, New Jersey, Illinois or Massachusetts Europe:Spain, Netherlands, Ireland or United Kingdom (Remote) CliniRx is seeking an experienced, independent and driven Clinical Trial Project Manager to successfully manage and deliver assigned clinical studies within timelines and budgets in compliance with Good Clinical Practices, and all Global, National and Local Regulations. Candidate will be responsible for the overall planning, coordination, implementation, and execution of end-to-end clinical trial from protocol development through study conduct and close out. Reporting to Project Director, the Clinical Trial Project Manager will also serve as a mentor to Associate Project Managers, Team Leads and Clinical Research Associates. 1) Key responsibilities:

• Be responsible for project planning, implementation, control, and evaluation for multiple studies with limited supervision.
• Develops study timeline in consultation and collaboration with the cross functional team.
• Coordinates and manages clinical study projects activities and team in a manner that ensures all study timelines, quality parameters, and budgetary requirements are met.
• Leads the development of global study-level documentation and the setup of the required tools and systems as per the requirements of the assigned studies.
• Leads development, implementation, and supervision of global Drug Supply Plan to ensure IP availability at the right place and the right time to support study needs.
• Designs the training requirements of the internal team and external team and vendors including, but not limited to, investigator meetings and supervise the implementation till closure.
• Ensures regulations are being implemented according to ICHGCP and applicable SOPs.
• Continuously monitors study quality and implement the required standards in order to meet compliance requirements.
• Performs financial management, including review and approval of site and vendor invoices.
• Oversees study supplies through their management cycle (requirements set up till used/discarded)
• Responsible for the biological sample management, coordinate trial related materials, including clinical trial supplies.
• Plans, organizes and manages internal team and client specific meetings at the prescribed timelines.
• Timely prepares and submits project status reports for senior management and sponsor
• Leads as well as Coordinates the cross functional team (Clinical Operations, Biometrics, Regulatory, Safety Medical Affairs, Finance and Legal) for the timely delivery of the contracted services according to CliniRx and sponsor standards.
• Manages relationships with Sites/PIs and other study-related vendors such as Central Labs, IVRS, Technology Partners, etc.
• Leads the identification, management and escalation of risks either alone or in collaboration with the cross-functional team.
• About 20% to 40% travel based on the project needs
• Participates in the development, review and implementation of departmental SOPs and processes.
• Supports in the preparation of Proposals, study Budgets and Timelines and Scope of Work/Service Agreements.
• Supports the identification and set up of third party providers and preferred partners.

2) Qualification and experience:

• Bachelor’s or Master’s degree in Life Science or Clinical Research Administration
• Minimum 7-10 years of project management and / or clinical operations experience within a global CRO, Biotech or Pharma with track record in managing multicenter clinical studies
• Working knowledge of current industry best practices, ICH GCP guidelines, and relevant regulations for the conduct of clinical trials
• Sound project management skills including expertise in metrics analysis and reporting methodologies in addition to proficiency in MS Project, MS Excel (pivot tables, graphing) and MS PowerPoint
• Experience working in or developing multidisciplinary teams to set up, and conduct clinical studies, preferable in the US and the EU
• Experience in therapeutic areas like CNS/Neurology, Oncology, Cardiovascular and Rare Disease will be a great advantage.

3) Skills:

• Able to lead a multicounty and multicultural team and communicate effectively.
• Versatile, resource full, adaptable and entrepreneurial and ‘can-do’ mind set.
• Be a role model for junior colleagues.
• Sound understanding of drug development process.
• Ability to manage complex situations through problem-solving, critical thinking and navigating ambiguity
• Experience supporting Business Development with budgets, proposals and bid defense within CRO environment.
• Be able to work across boundaries

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