Sr. Clinical Project Manager/associate Director
vor 5 Monaten
The Senior Clinical Project Manager/Associate Director, Clinical Operations will provide operational expertise within the Research and Development function to ensure timely initiation, execution and reporting of clinical trials in accordance with ICH/GCP and all applicable requirements (including local regulations) to support licensure of products in the United States and global markets. This role will work closely and collaboratively with the Global Clinical Operations Manager(s) and cross-functional collaborators (Program Management, Data Management, Clinical Development, Medical Writing, Biostatistics, Clinical Supply, Global Medical Safety, GCP Quality and Regulatory) as well as Clinical Research Organizations, to ensure the timely execution of studies, with specific focus on clinical activities in Europe. Emphasis will be on superior execution, transparency within the department and to Senior Management.
This position will be based in the Kiniksa Pharmaceuticals, GmbH office in Zug, Switzerland. Significant collaboration will also be required with all core functions in the USA and Europe.
**Responsibilities **_(including, but not limited to)_**:
- Independently manage all operational aspects for implementation of clinical trial activities from study start-up through database lock, ensuring adherence to protocol, GCPs and relevant SOPs
- Lead internal cross-functional study teams and partner with CROs to ensure effective and timely communication, study execution in accordance with the timeline and budget
- Manage study-related vendors and serve as the primary point of contact for contracted CROs, study staff and contract labs; identifying potential risks and proactively resolving issues with CROs; establishing vendor management plans and reviewing quality metrics
- Perform and/or oversee site monitoring visits for clinical trials as needed
- Facilitate the timely completion of study protocols (including amendments) and development (and revision) of electronic clinical trial systems (e.g., EDC, IRT)
- Provide input into and/or developing study-related materials such as Clinical Monitoring Plans, Data Management Plans, eCRF forms and completion guidelines, protocols, patient informed consent drafts, site instructions for specimen collections, and study drug order forms
- Review monitoring reports, protocol deviations and data listings for sponsored studies to ensure reliable quality data are delivered
- Coordinate with CROs on site selection, IRB submissions, site initiation and close-out planning.
- Manage in a timely and efficient manner all operational aspects of protocol amendments
- Developing and managing reports for communicating study progress and key metrics to Senior Management and program team
- Coordinate the negotiation of site budgets within guidelines and providing oversight for site payments per contracts
- Facilitate site study drug orders, and ensuring full drug chain record management, including site accountability records are maintained. Management of non-drug supply ordering and tracking, as required
- Provide oversight and ensuring maintenance of clinical trial master files to ensure their compliance with required regulatory and ICH/GCP quality standards and consistency with SOPs
- Provide input to Drug (IND) filings, Clinical Trial Applications (including EU-CTR), safety reports, clinical study reports and other ICH compliant sections of registration dossiers (e.g., BLA, MAA, NDA, etc.)
- Provide oversight of clinical trials to ensure that all adverse events or product safety issues are captured, reported and evaluated by appropriate Clinical personnel in a timely manner
- Establish a system and procedure for forecasting (and reforecasting) needs for investigational product for each study and communicating those needs on a routine basis
- Ensure inspection readiness and participating with CROs and providing support to sites to prepare for clinical audits/inspections and to respond to audit/inspection findings conducted by internal QA and external regulatory agencies
**Qualifications**:
- Requires a Bachelor’s Degree in health or biologic science (BS/BA/BScN or higher); masters-level degree is preferred
- Requires a minimum of 7 years clinical operations experience in biopharmaceutical industry with 4 years as a clinical project management required; global clinical trial experience is required
- Effective project management and risk management skills
- Excellent listening, communication (written, spoken) and interpersonal skills, ability to foster team spirit
- Site monitoring and clinical quality compliance experience are strongly preferred
- Advanced knowledge of Good Clinical Practices and current knowledge of FDA regulations for IND clinical trials is required; working knowledge of EU country-specific regulatory requirements is required
- Solid well-grounded experience in setup, execution and operational management of Phase 1, 2, and 3 clinical trials across an array of th
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