Ref #: 36088
Employment type: Permanent - Full-Time
Location: home based Germany
Posted: 24-Jun-2022
Description
Roles & Responsibilities of the position:
The Local Clinical Trial Manager will be responsible for managing local clinical studies including operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities. This role is the primary point of contact at a country level for assigned studies.
Key Responsibilities:
• Work with regional matrix team (e.g. CRA, CTA, etc.) to ensure delivery of country and site level study activities in alignment with the global study project plan.
• Responsibility for site feasibility assessment and implementation of any local criteria for site selection.
• Contribution of input to the Trial Plan, Safety Monitoring Plan, Filing and Archiving Plan and Investigational Product documents at a country level.
• Lead of local project planning activities to meet recruitment targets. Including but not limited to development of local trial specific procedures and tools, recruitment planning, contingency and risk management and budget forecasting.
• Monitoring of country progress and initiation of corrective and preventive actions when the trial deviates from plans and communication of study progress and issues to study management teams.
• Review and approval of Monitoring Visit Reports submitted by CRA. Identification of issues and/or trends across a trial project and escalation of deviation issues to the Global Trial Manager as needed.
• Establish and maintain excellent working relationships with external and internal stakeholders.
• Active contribution to process improvement; training and mentoring of Clinical Trial Administrators, CRA’s and other Study Managers.
Job Requirements:
• Degree in Life Sciences or similar
• Minimum of 2 years of solid clinical study management experience in Germany in a big CRO or pharmaceutical company
• Solid understanding of the drug development process including ICH/GCP and local regulatory requirements
• Solid communication and computer skills
• Proficiency in speaking and writing German and English
• Flexible mindset and ability to work at a fast pace within small exploratory study teams
• Ability to work on multiple trials in parallel in different indications
What is offered:
• Possibility to get a foot in the door of one of the biggest and most successful global pharmaceutical sponsors
Permanent contract
• Great work atmosphere
• Contribution to pension scheme
To apply:
Would you like to know more? We are looking forward to your application by either submitting your CV via email to anja.potrafke@docsglobal.com or apply via our career portal on www.docsglobal.com. We are looking forward to hearing from you.
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
#pmjob
#crajob
The Local Clinical Trial Manager will be responsible for managing local clinical studies including operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities. This role is the primary point of contact at a country level for assigned studies.
Key Responsibilities:
• Work with regional matrix team (e.g. CRA, CTA, etc.) to ensure delivery of country and site level study activities in alignment with the global study project plan.
• Responsibility for site feasibility assessment and implementation of any local criteria for site selection.
• Contribution of input to the Trial Plan, Safety Monitoring Plan, Filing and Archiving Plan and Investigational Product documents at a country level.
• Lead of local project planning activities to meet recruitment targets. Including but not limited to development of local trial specific procedures and tools, recruitment planning, contingency and risk management and budget forecasting.
• Monitoring of country progress and initiation of corrective and preventive actions when the trial deviates from plans and communication of study progress and issues to study management teams.
• Review and approval of Monitoring Visit Reports submitted by CRA. Identification of issues and/or trends across a trial project and escalation of deviation issues to the Global Trial Manager as needed.
• Establish and maintain excellent working relationships with external and internal stakeholders.
• Active contribution to process improvement; training and mentoring of Clinical Trial Administrators, CRA’s and other Study Managers.
Job Requirements:
• Degree in Life Sciences or similar
• Minimum of 2 years of solid clinical study management experience in Germany in a big CRO or pharmaceutical company
• Solid understanding of the drug development process including ICH/GCP and local regulatory requirements
• Solid communication and computer skills
• Proficiency in speaking and writing German and English
• Flexible mindset and ability to work at a fast pace within small exploratory study teams
• Ability to work on multiple trials in parallel in different indications
What is offered:
• Possibility to get a foot in the door of one of the biggest and most successful global pharmaceutical sponsors
Permanent contract
• Great work atmosphere
• Contribution to pension scheme
To apply:
Would you like to know more? We are looking forward to your application by either submitting your CV via email to anja.potrafke@docsglobal.com or apply via our career portal on www.docsglobal.com. We are looking forward to hearing from you.
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
#pmjob
#crajob