Great job opportunity for a PROJECT LEAD CLINICAL TRIALS 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 pharmaceutical industry.
Currently we are looking for a proven professional to join our international Project Managemnt team.
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;
Core strengths of Comac Medical
- Proven track record for quality and delivery;
- Established and trusted relationships with KOLs;
- Motivated, capable and dedicated team;
- Global full-service capabilities;
If you are interested, challenged and convinced that the job opportunity is exactly for you, do not hesitate and send your detailed resume in English.
Only the shortlisted candidates will be contacted in a timely manner.