Ogłoszenie numer: 5299979, z dnia 2021-08-20
Established in 1997, with locations in Central & Eastern Europe and 290 full-time dedicated professionals, COMAC MEDICAL is a full-service providers of CRO and SMO with headquarter in Sofia, Bulgaria.
Miejsce pracy: lubuskie
What is expected to be done?
- Monitor and manage project milestones and timelines as per the contract obligations;
- Determine project-specific oversight metrics, as needed, in agreement with the client;
- Perform risk assessment and propose mitigation strategy for the project;
- Prepare, oversee, and review documents related to assigned clinical research project;
- Provide regular updates of project status to the client and operational team;
- Ensure effective and proper communication between all parties involved in the project;
- Coordinate and conduct internal kick-off meeting as well as of kick-off meeting with the client;
- Organize and supervise of project-specific training;
- Oversee and control all logistic procedures related to the study and serve as a signal point of contact for the management and client;
- Fully involved in resolving project issues, as well as take part in procedure improvement initiatives;
- Supervise of project submission/approval process to EC/RA;
- Support quality group in preparation of project-specific audit as needed;
- Translation of project-specific documents, when necessary;
- Participate in marketing activities, client presentations, and proposal development;
What is required for the role?
- Graduate or postgraduate degree, preferably in the filed of Biology, Pharmacy, Chemistry or other relevant;
- Minimum 3 years of experience in the leading role in a clinical research filed;
- Excellent knowledge of clinical research process;
- Excellent knowledge of current ICH/GCP guidelines and country-specific regulations;
- Exceptional problem-solving, organizational, and leadership skills;
- Outstanding communication skills – able to successfully convey massages across both dedicated team and external teams involved in the clinical research;
- Ability to keep deadlines for multiple projects in a demanding working environment;
- Ability to pay attention to details, absorb and analyse specific project data;
- Working knowledge of Word, Excel, and Power Point;
- Fluency in English language.
Why to join Comac Medical?
- Great team of knowledgeable, high-achieving and experienced professionals;
- International and diverse work atmosphere;
- Challenging projects in a different therapeutical area as well as in early phases;
- Opportunity to enrich professional skills and progress in career development;
- Competitive remuneration;
- Professional trainings.