CLINICAL RESEARCH PROJECT LEADER

What is expected to be done?

• Monitor and manage project milestones and timelines as per the contractual 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 the assigned clinical research project;
• Provide regular updates on 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 meetings as well as kick-off meetings with the client;
• Organize and supervise 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 taking part in procedure improvement initiatives;
• Supervise of project submission/approval process to EC/RA;
• Support quality group in the preparation of project-specific audits 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 field;
• 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 messages 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 analyze specific project data;
• Working knowledge of Word, Excel, and PowerPoint;
• Fluency in English language;

Why 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 salary and social benefits;

Core strengths of Comac Medical:

• Dedicated state-of -art Phase I Unit;
• Proven track record for quality and delivery;
• Established and trusted relationships with KOLs;
• Motivated, capable and dedicated team;
• Global full-service capabilities;