Currently we are working with biotechnology company which is developing a pipeline of biologic therapeutics for the treatment of cancers and other immune disorders. Together we are looking for talented people for the position of:
Clinical Research Manager / Poland
Location: Cracow, Poland
Our Client has decided to create a new position of Clinical Research Manager, who will be responsible for leadership and management of one or more programs in Clinical Trial Management.
The goal of this position is to lead clinical operations activities and to make decisions regarding quality, timelines and budgets related to the progress of clinical research studies, in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs).
The perfect Candidate has a thorough understanding of the clinical trials protocols, and is able to anticipate potential issues that may arise during the conduct of the trial, in close collaboration with CROs.
You will be responsible for:
• Managing ongoing and future clinical programs
• Providing operational insight into feasibility, timeline and cost estimates during clinical program/study development
• Overviewing of clinical programs status and issues and proactive communication of progress, risks, issues or changes that may impact quality, timelines or budget, presenting the data to CTM team
• Participating in the development of the organizations strategic plans for product development including the design, feasibility, and costing of studies and clinical trials to meet the organizations goals.
We expect from you:
• Pharmaceutical or relevant Life Sciences degree
• Min. 5 years of experience in clinical research (you will be highly regarded if you also have experience in Phase I & II clinical trials)
• Demonstrated operations experience in a Clinical Research Organization (CRO) or a pharma company
• Experience in line management of teams comprising at least 10 people
• in-depth knowledge of global regulatory/industry guidelines (e.g. ICH/GCP, promotional guidelines and labeling)
• Excellent communication, organizational, time-management and presentation skills in both Polish and English.
We can offer:
• Challenging work
• The sense of building and expanding innovation business,
• Attractive salary and bonus scheme
• Additional perks
Candidates who are interested to apply for this position please send us your resume in English by clicking Apply button