Informacje o stanowisku

• Managing the project from the initiation to closure- Assure gathering of relevant information after assignment to the project.
• Assist CFD in the contracting process, when required.
• Perform activities with the feasibility team, related to the project, if required.
• Communicate with internal teams for resource allocation to the project.
• Create project management plans and related to them attachments (e.g. Project management plan, Communication plan, Risk Management plan, Trial master file plan, Protocol deviation plan, Training plan, etc.).
• Perform oversight of project submission/ approval process to EC/ RA.
• Determine project-specific performance metrics, as needed, in agreement with the client.
• Organize and lead internal kick-off meeting as well as kick-off meeting with the client-
• Arrange translation of project-specific documents, when necessary.
• Perform risk assessment and propose mitigation strategy for the project.
• May serve as a single point of contact with the client.
• Delegate tasks and responsibilities to appropriate team members.
• Could be a mentor for initial practical training.

• Perform tracking and control of the outcomes, over the project milestones and timelines as per the contract obligations, as directed, in the required format
• Ensure that the projects are organized and executed in a consistent manner
• Provide regular updates of project status to the client in an established line of communication and format, and the operational team
• Perform organization and supervision of project-specific training
• Perform issue management process on the project level
• Ensure effective and proper communication between all parties involved in the project
• Perform the supervision and control of logistic procedures related to the study
• Ensure project closure including completion of lessons learned, required documentation, and collecting feedback from the Sponsor
• Support quality group in preparation of project-specific audit, as needed
• Assume additional responsibilities as directed by the SPM or GHPM

• Participate in marketing activities, client presentations, and proposal development
• Participate in and/or attend professional and industry meetings as a representative of Comac Medical

• Graduate or postgraduate in the field of natural (life/chemistry) sciences or medical sciences or healthcare or pharmacy, or medicine from an accredited college or university or equivalent combination of education and experience.
• At least 4 years in management of clinical trials projects.
• Thorough knowledge of clinical research process, including working knowledge of all functional areas of clinical trial management
• Working knowledge of current ICH/GCP guidelines and applicable country-specific regulations
• Excellent organizational, communication (verbal and written) and interpersonal skills with the ability to adapt and adjust to changing priorities
• Effective presentation style for all levels of stakeholders
• Strong problem-solving, decision-making, issue-analysis and resolution skills
• Positive attitude and ability to interact with all levels of staff and to maintain a high degree of confidentiality with the assigned teams
• Ability to work in a multicultural diverse work environment and to coordinate multiple teams in various locations and/or time zones
• Ability to understand interdependencies between business needs, operations, and functional requirements, and to address it
• Computer literacy - working knowledge of MS Office (Word, Excel, and PowerPoint), familiarity with eClinical systems (CTMS, EDC, eTMF, etc.).

• Join a team of knowledgeable, high-achieving, and experienced professionals.
• Experience an international and diverse work atmosphere.
• Take on challenging projects in various therapeutic areas, including early phases.
• Enhance your professional skills and progress in your career development.
• Enjoy competitive remuneration and access to professional training.

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