Great job opportunity for a Senior Project Manager for one of the most reputable, full-service providers of CRO and SMO
Established in 1997, with locations in Central & Eastern Europe and 290 full-time dedicated professionals, COMAC MEDICAL is a recognized leader in clinical research and provides innovative and non-conventional solutions of high quality for the pharmaceutical industry.
Currently, we are looking for an inspiring Leader to join our Global Project Management team of highly achieved and dedicated professionals.
Senior Project Manager - Clinical Trials
Project planning and setup:
- 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.
Project execution and control:
- 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
Business Development:
- Participate in marketing activities, client presentations, and proposal development
- Participate in and/or attend professional and industry meetings as a representative of Comac Medical
Knowledge, skills & abilities:
- 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.).
Why join COMAC MEDICAL?
- 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.