English
ITBMed is an international biopharmaceutical company committed to improving the lives of patients worldwide.
ITBMed seeks to deliver innovative and life-changing therapies using targeted immunomodulatory biologics within the organ transplantation and autoimmunity disease areas.
The lead candidate drug siplizumab is a monoclonal antibody in clinical development, which has shown significant potential in transforming the life for organ transplant patients, by allowing the complete discontinuation of all immunosuppression treatment and restoration of a normal life.
ITBMed also has a strong preclinical research and development profile, in collaboration with premier US and European universities, that has the potential to provide novel IP and break ground for new indications and treatments.
ITBMed acts globally and has core operations in the United States and in Sweden.
For more information about ITBMed, please see https://itb-med.com/
ITBMed seeks to deliver innovative and life-changing therapies using targeted immunomodulatory biologics within the organ transplantation and autoimmunity disease areas.
The lead candidate drug siplizumab is a monoclonal antibody in clinical development, which has shown significant potential in transforming the life for organ transplant patients, by allowing the complete discontinuation of all immunosuppression treatment and restoration of a normal life.
ITBMed also has a strong preclinical research and development profile, in collaboration with premier US and European universities, that has the potential to provide novel IP and break ground for new indications and treatments.
ITBMed acts globally and has core operations in the United States and in Sweden.
For more information about ITBMed, please see https://itb-med.com/
Clincal Trial Manager (CTM)
Position: Clinical Trial Manager (CTM)
Department: Clinical Operations Reporting
Reporting into: Executive Director, Clinical Operations
Location: Stockholm, Sweden
Position Description
The clinical trials associated with ITBMed development programs will be performed on a global scale in coordination with internal team members and external vendors. These studies will be submitted to health care regulatory authorities around the world such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA). We are seeking a Clinical Trial Manager (CTM) with keen attention to detail who will be responsible for the overall planning, execution and management of the Clinical Trials to which they are assigned. The CTM will provide strategic and operational leadership of assigned research studies to ensure project delivery on time, within budget, and of high quality according to FDA regulations, Good Clinical Practice (GCP), International Conference on Harmonization (ICH) and relevant Standard Operating Procedures (SOPs). The CTM will independently lead complex, in-house or outsourced, clinical studies at any point in the life cycle of the trial and will be the primary operational contact for the study.
Essential Duties & Responsibilities
Involves a combination of execution and oversight, dependent on the sourcing model, to ensure deliverables and may include, but is not limited to, the following:
Key Responsibilities
• Responsible for daily management of assigned clinical studies ensuring successful implementation and execution from study start up, maintenance and close-out
• Authors and provide operational and strategic input for clinical study protocols, model informed consent forms, clinical study reports and other clinical study documents as necessary
• Manage the subject recruitment and retention strategy and related initiatives (e.g., recruitment material as applicable)
• Provide input and communicate with the appropriate team members to provide support and responses to country/regulatory and IRB/IEC submissions and reviews
• Oversee clinical monitoring and ensure quality and adherence to established processes and plans
• Oversee clinical study vendors
• Support the development, management, and review of vendor scope of work (SOW), invoices, and accruals as per the contract, quality requirements, and budget
Core Competencies, Knowledge and Skill Requirements
• Leadership and clinical trial management experience
• Excellent verbal and written communication skills
• Daily demonstration of a positive, ‘can do’ and service-oriented attitude; detail-oriented with a commitment to accuracy
• Ability to multi-task and shift priorities quickly while working under tight deadlines
• Proficiency in MS Office (Outlook, Word, Excel, PowerPoint)
• Able to travel up to 20% as required by business needs. International travel may be required at times
Communication & Interpersonal Skills
• Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company
• Dynamic and innovative skills with a well-developed sense of teamwork
• ITBMed is a fast-moving small-medium company, with a sense of urgency around what we do. A successful colleague will manage ambiguity and uncertainty successfully, and can develop and execute project plans within a busy environment
Opportunities with the position
• Be part of ITBMed, an innovative development company with solid finances and a long-term stable ownership
• Become a key player in ITBMed's continued global development of specific immunomodulatory biologics for transplantation, autoimmunity, neurodegenerative diseases, and gene therapy
• Opportunity to contribute from the protocol writing phase to the final report of ITBMed's global clinical development program
• Lots of contact and networking opportunities with study sites and their staff
• Great opportunities for learning and knowledge exchange
• Become a key leader and work together with highly skilled professional colleagues, in Sweden as well as in the US, to build the company and be part of an exciting journey
• Work in a prestigious and humble atmosphere and become a part of a close-knit team with a lot of laughter and humor
• Have a broad responsibility with short decision lines and a great opportunity to influence
REQUIREMENTS
Education:
• Bachelor of Science in a closely relevant field
Experience:
• Solid experience as CTM in a small or mid-sized pharmaceutical company or in a CRO setting. Experience from a large pharmaceutical company is an advantage
• Clinical Monitoring experience preferred
Contact, information and application:
Andrea Backlund
Recruitment Consultant
andrea.backlund@peaksearch.se
+4670-235 67 96
Magnus Klingberg
Sr Recruitment Consultant
magnus.klingberg@peaksearch.se
+4670-678 09 92
Http://peaksearch.se/start/
Department: Clinical Operations Reporting
Reporting into: Executive Director, Clinical Operations
Location: Stockholm, Sweden
Position Description
The clinical trials associated with ITBMed development programs will be performed on a global scale in coordination with internal team members and external vendors. These studies will be submitted to health care regulatory authorities around the world such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA). We are seeking a Clinical Trial Manager (CTM) with keen attention to detail who will be responsible for the overall planning, execution and management of the Clinical Trials to which they are assigned. The CTM will provide strategic and operational leadership of assigned research studies to ensure project delivery on time, within budget, and of high quality according to FDA regulations, Good Clinical Practice (GCP), International Conference on Harmonization (ICH) and relevant Standard Operating Procedures (SOPs). The CTM will independently lead complex, in-house or outsourced, clinical studies at any point in the life cycle of the trial and will be the primary operational contact for the study.
Essential Duties & Responsibilities
Involves a combination of execution and oversight, dependent on the sourcing model, to ensure deliverables and may include, but is not limited to, the following:
Key Responsibilities
• Responsible for daily management of assigned clinical studies ensuring successful implementation and execution from study start up, maintenance and close-out
• Authors and provide operational and strategic input for clinical study protocols, model informed consent forms, clinical study reports and other clinical study documents as necessary
• Manage the subject recruitment and retention strategy and related initiatives (e.g., recruitment material as applicable)
• Provide input and communicate with the appropriate team members to provide support and responses to country/regulatory and IRB/IEC submissions and reviews
• Oversee clinical monitoring and ensure quality and adherence to established processes and plans
• Oversee clinical study vendors
• Support the development, management, and review of vendor scope of work (SOW), invoices, and accruals as per the contract, quality requirements, and budget
Core Competencies, Knowledge and Skill Requirements
• Leadership and clinical trial management experience
• Excellent verbal and written communication skills
• Daily demonstration of a positive, ‘can do’ and service-oriented attitude; detail-oriented with a commitment to accuracy
• Ability to multi-task and shift priorities quickly while working under tight deadlines
• Proficiency in MS Office (Outlook, Word, Excel, PowerPoint)
• Able to travel up to 20% as required by business needs. International travel may be required at times
Communication & Interpersonal Skills
• Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company
• Dynamic and innovative skills with a well-developed sense of teamwork
• ITBMed is a fast-moving small-medium company, with a sense of urgency around what we do. A successful colleague will manage ambiguity and uncertainty successfully, and can develop and execute project plans within a busy environment
Opportunities with the position
• Be part of ITBMed, an innovative development company with solid finances and a long-term stable ownership
• Become a key player in ITBMed's continued global development of specific immunomodulatory biologics for transplantation, autoimmunity, neurodegenerative diseases, and gene therapy
• Opportunity to contribute from the protocol writing phase to the final report of ITBMed's global clinical development program
• Lots of contact and networking opportunities with study sites and their staff
• Great opportunities for learning and knowledge exchange
• Become a key leader and work together with highly skilled professional colleagues, in Sweden as well as in the US, to build the company and be part of an exciting journey
• Work in a prestigious and humble atmosphere and become a part of a close-knit team with a lot of laughter and humor
• Have a broad responsibility with short decision lines and a great opportunity to influence
REQUIREMENTS
Education:
• Bachelor of Science in a closely relevant field
Experience:
• Solid experience as CTM in a small or mid-sized pharmaceutical company or in a CRO setting. Experience from a large pharmaceutical company is an advantage
• Clinical Monitoring experience preferred
Contact, information and application:
Andrea Backlund
Recruitment Consultant
andrea.backlund@peaksearch.se
+4670-235 67 96
Magnus Klingberg
Sr Recruitment Consultant
magnus.klingberg@peaksearch.se
+4670-678 09 92
Http://peaksearch.se/start/