SpectraCure AB is a medical device company active in the area of prostate cancer treatment. We are about to initiate a phase I/II trial in North America with a drug/device combination treatment. We now seek a project manager for the trial. We are looking for a dedicated person with previous experience in clinical trial management.
The tasks will include:
• coordinating all activities at the sponsor, clinical sites, and local CRO
• being the primary point of contact between sponsor, clinical sites and CRO
• handling logistics such as transporting equipment and organizing meetings
• have an overview of regulatory matters and inform about and perform or delegate regulatory tasks as required
• establishing project descriptions and plans
• achieving project targets - time, quality, bottom line etc.
• establishing project budget
• all project interface such as, but limited to the company organisation, subcontractors etc.
• management of, but not limited to project crew/personnel, sub projects, subcontractors and municipalities
• progressing project reporting, time cost and quality
• keeping track of deviations (additional works/delays etc.)
• detailed and overall planning of all activities within project
• that the quality management system will be followed
• that the health and environmental policies are followed
• that set project standard/quality will be implemented
• all logistics
• informing himself/herself of project progress and changes
Profile:
• Previous experience in clinical trial management in medical device and/or drug development. Experience in both is considered a plus.
• Experience in clinical trials in USA and/or Canada is considered a plus.
• The Project Manager shall be capable to work under uncertain conditions. She/he shall have the ability to prioritise and handle multiple tasks under heavy and demanding workload. She/he is goal-oriented, self-motivated and committed to the successful outcome of the project. It is also important to accept that it will exist a number of issues to be solved and trying periods of time in the project start-up phase as well as along the project. She/he must also be flexible to travel and additional working hours.
• The Project Manager shall also be able to manage and encourage personnel in a professional manner. Excellent skill in English is needed.
Experience:
• A senior person with several years of experience in managing projects. The Project Manager shall also be well aware of the Medical Device market.
For more information, please contact CEO Masoud Khayyami 0708 15 21 90 or CTO Johannes Swartling 0708 23 36 80 and visit our website www.spectracure.com. Please send your job application to Masoud Khayyami mk@spectracure.com by 15th December.
The tasks will include:
• coordinating all activities at the sponsor, clinical sites, and local CRO
• being the primary point of contact between sponsor, clinical sites and CRO
• handling logistics such as transporting equipment and organizing meetings
• have an overview of regulatory matters and inform about and perform or delegate regulatory tasks as required
• establishing project descriptions and plans
• achieving project targets - time, quality, bottom line etc.
• establishing project budget
• all project interface such as, but limited to the company organisation, subcontractors etc.
• management of, but not limited to project crew/personnel, sub projects, subcontractors and municipalities
• progressing project reporting, time cost and quality
• keeping track of deviations (additional works/delays etc.)
• detailed and overall planning of all activities within project
• that the quality management system will be followed
• that the health and environmental policies are followed
• that set project standard/quality will be implemented
• all logistics
• informing himself/herself of project progress and changes
Profile:
• Previous experience in clinical trial management in medical device and/or drug development. Experience in both is considered a plus.
• Experience in clinical trials in USA and/or Canada is considered a plus.
• The Project Manager shall be capable to work under uncertain conditions. She/he shall have the ability to prioritise and handle multiple tasks under heavy and demanding workload. She/he is goal-oriented, self-motivated and committed to the successful outcome of the project. It is also important to accept that it will exist a number of issues to be solved and trying periods of time in the project start-up phase as well as along the project. She/he must also be flexible to travel and additional working hours.
• The Project Manager shall also be able to manage and encourage personnel in a professional manner. Excellent skill in English is needed.
Experience:
• A senior person with several years of experience in managing projects. The Project Manager shall also be well aware of the Medical Device market.
For more information, please contact CEO Masoud Khayyami 0708 15 21 90 or CTO Johannes Swartling 0708 23 36 80 and visit our website www.spectracure.com. Please send your job application to Masoud Khayyami mk@spectracure.com by 15th December.
Project Manager Clinical Study