Project Manager PASS - Korean Nationals Only
Fa Euzi Saasfaprod1 · Republic of, South Korea
About The Role
The Project Manager (Local Project Team-Post Authorization Safty Study) is primarily responsible for the planning and management of all contracted responsibilities for assigned projects. Act as primary contact between Novotech and client. Leads and oversees the execution of clinical projects in accordance with local regulation, Novotech/client SOPs and the Project Agreement to deliver the project on time and to budget. Project Manager is responsible for the overall project deliverables, leading the internal team and the financial performance of the project. Project Managers are responsible for the delivery of the project from site selection through to Close out of the study including all deliverables within scope. Project Managers are expected to have a solid understanding of the drug development and clinical trial process, the role and workings of a Clinical Research Organisation (CRO), international and local regulatory requirements.
Responsibilities
- Lead overall clinical study delivery from site selection and study start-up through study close-out, ensuring timelines, quality, and contractual requirements are met in compliance with applicable regulations and SOPs.
- Manage cross-functional project teams and resources, coordinating Clinical Operations, Regulatory, Medical, Biometrics, Pharmacovigilance, vendors, and other stakeholders to achieve study objectives.
- Serve as the primary client contact, providing regular study updates, facilitating communication between the Sponsor, project team, and sites, and proactively managing client expectations, risks, and issues.
- Oversee project financial management, including study budget, revenue forecasting, profitability, scope management, and change orders in collaboration with relevant internal teams.
- Drive proactive project and risk management, monitoring study progress and key deliverables, identifying and resolving operational issues, and implementing appropriate mitigation and contingency plans.
Minimum Qualifications & Experience
- Graduate in a clinical or life sciences related field.
- Relevant experience/qualifications in allied professions may also be considered.
- At least 5 years’ experience within the clinical research industry and previous experience in project management of late phase studies, including Associate Project Manager or equivalent.
- CRO experience is advantageous.
Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.
Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.
We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.
We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to talking to you about working at Novotech.
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