Clinical Trial Liaison Job at iconplc (Sofia)

Manager, Clinical Operations, International

Cabaletta is seeking a Manager/Sr Manager, Clinical Operations, International. R...

Location

Germany; Switzerland

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor’s Degree or advanced degree in life sciences or related field
Minimum 4 years of clinical trial management experience including management of study resources, vendors, budgets, supplies, critical path activities, and risk management, within Biotech or pharmaceutical industry or equivalent by experience
Cell therapy experience preferred and/or focus complex therapies
Fluency in English
working proficiency in additional European languages a plus
Experience with early phase, complex trials
Experience managing Contract Research Organizations and other external vendors
Good understanding of European regulatory requirements (EMA, MHRA, etc)
Working knowledge of GCP/ ICH regulatory guidelines
Extensive knowledge of standard industry practices related to study start-up, site management and monitoring, document management, and clinical supply management

Job Responsibility

Provide day-to-day clinical project management oversight of the full range of clinical operations activities associated with clinical trial conduct from protocol development, feasibility/capability assessments, initiation, execution, control, and closure
Perform hands-on activities not outsourced to vendors, as needed
Author study documents and plans such as ICF and study specific plans
Provide input and review of site training materials
Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
Proactively identify risks and lead team members to mitigate risks in a timely fashion
Develop and maintain positive relationships, both internal and external to project, including site personnel (KOLs, PIs, Study Coordinators)
Select and manage vendors
Perform and document study-level Sponsor Oversight of outsourced clinical activities
Execute clinical operations country submission tasks and documents: Review submission pack, coordinate country-specific ethics RFIs, review and update site-specific consent forms

What we offer

health and retirement
PTO
stock option plans

Medical Science Liaison

As a Medical Science Liaison, you will advance medical science through clinical ...

Location

Algeria , Algiers

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Excellent product knowledge and expertise
Outstanding presentation and communication skills in both the local language and English
Proven teaching capabilities and an understanding of adult learning concepts
Effective critical thinking skills and strategy implementation
A broad understanding of the regulatory and healthcare environment in the country/region
Excellent organizational skills, resilience, and empathy
An MD and/or PhD and/or equivalent healthcare qualifications, preferably with proven MSL experience
2-3 years post-graduate experience within the healthcare industry
Clinical trial experience with knowledge of GCP
Training in adverse event reporting

Job Responsibility

Identifies and advances clinical needs, ensuring that we continually meet the evolving requirements of the healthcare community
Acts as the primary contact for investigator-initiated trials, facilitating the successful implementation of research initiatives
Assists in the development of publication plans to share new findings and insights with the broader medical community
Supports the medical manager in the review of promotional materials, ensuring they comply with the highest standards of accuracy and compliance
Acts as a liaison with the medical community, including medical professional societies, opinion leaders, investigators, and consultants
Supports the medical director/medical manager in collaborating with opinion leaders
Provides accurate and balanced medical-scientific education and information on products, therapies, issues, trends, and clinical research
Conducts demonstrations and in-services at customer sites
Assists in the development of medical-scientific advisory boards, symposia, and educational forums
Educates and trains internal staff on products and therapies

Fulltime

Medical Science Liaison

As a MEDICAL SCIENCE LIAISON in Algeria at Baxter you will play a pivotal role i...

Location

Algeria , Algiers

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Excellent product knowledge and expertise
Outstanding presentation and communications skills in both the local language and English
Proven teaching capabilities and an understanding of adult learning concepts
Effective critical thinking skills and strategy implementation
A broad understanding of the regulatory and healthcare environment in the country/region
Excellent organizational skills, resilience, and empathy
An MD and/or PhD and/or equivalent healthcare qualifications, preferably with proven MSL experience
2-3 years post-graduate experience within the healthcare industry
Clinical trial experience with knowledge of GCP
Training in adverse event reporting

Job Responsibility

Identifies and advances clinical needs, ensuring that we continually meet the evolving requirements of the healthcare community
Acts as the primary contact for investigator-initiated trials, facilitating the successful implementation of research initiatives
Assists in the development of publication plans to share new findings and insights with the broader medical community
Supports the medical manager in the review of promotional materials, ensuring they compete with the highest standards of accuracy and compliance
Acts as a liaison with the medical community, including medical professional societies, leaders with a point of view, visionaries, investigators, and consultants
Supports the medical director/medical manager in collaborating with leaders with a point of view, encouraging relationships that drive innovation and excellence in medical science
Provides accurate and fair-balanced medical-scientific education and information on products, therapies, issues, trends, and clinical research
Conducts demonstrations and in-services at customer sites to ensure flawless clinical use of products
Assists in the development of medical-scientific advisory boards, symposia, and other educational forums
Educates and trains internal staff on products, therapies, issues, trends, and clinical research, ensuring our team remains at the forefront of medical knowledge

Fulltime