Ľutujeme, spoločnosť ponúkajúca danú pracovnú pozíciu ukončila zverejnenie ponuky na stránke.
Ďakujeme za porozumenie.
Zobraziť podobné ponuky
Ďakujeme za porozumenie.
Zobraziť podobné ponuky
ICF (Informed Consent Form) Lead
IQVIA RDS Slovakia, s. r. o.
Place of work
Vajnorská 100, Bratislava
Vajnorská 100, Bratislava
Contract type
full-time
full-time
Wage (gross)
1 700 EUR/month*Our offer to you may be higher based on your experience.
1 700 EUR/month*Our offer to you may be higher based on your experience.
Information about the position
Job description, responsibilities and duties
Perform tasks at a global level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.
As an ICF Lead you will oversee overall processes of ICF Development and associated project/study team activities:
Manage / author development and roll out of project instructions (global and country), templates, and supporting documentation including training materials to enable ICF development at master / country level
Coordinate implementation of changes to developmental processes and documentation when global / regional regulations impacting multiple countries arise
Implementation / roll out of ICF changes when new / revised ICF templates and guidelines are generated
Review Patient Informed Consent Form (ICF) for completeness and accuracy
Verify ICFs against Study protocol
Review, establish and agree on project planning and project timelines with sponsor and team
Distribute reviewed core level ICFs to ICF Specialists
Review, track and follow up the progress, the approval and execution of ICF documents
Review country level ICFs and adjust in accordance with study specific requirements
Review and provide feedback to management on the project status
Communicate key changes in these documents to a Sponsor
Ensure accurate completion and maintenance of internal systems, databases, and tracking tools with project specific information
Support team of ICF specialists in resolving their enquiries and provide cross-functional training and support as required
Act as a point of escalation
Qualifications
• Experience with ICF writing
• 1 year of clinical research experience in similar role at minimum or equivalent combination of education, training and experience is required.
• Ability to build strong relationships with stakeholders is essential, experience in sponsor facing role is strongly preferred
• Ability to lead the team on assigned projects
• Good analytical and organizational skills
As an ICF Lead you will oversee overall processes of ICF Development and associated project/study team activities:
Manage / author development and roll out of project instructions (global and country), templates, and supporting documentation including training materials to enable ICF development at master / country level
Coordinate implementation of changes to developmental processes and documentation when global / regional regulations impacting multiple countries arise
Implementation / roll out of ICF changes when new / revised ICF templates and guidelines are generated
Review Patient Informed Consent Form (ICF) for completeness and accuracy
Verify ICFs against Study protocol
Review, establish and agree on project planning and project timelines with sponsor and team
Distribute reviewed core level ICFs to ICF Specialists
Review, track and follow up the progress, the approval and execution of ICF documents
Review country level ICFs and adjust in accordance with study specific requirements
Review and provide feedback to management on the project status
Communicate key changes in these documents to a Sponsor
Ensure accurate completion and maintenance of internal systems, databases, and tracking tools with project specific information
Support team of ICF specialists in resolving their enquiries and provide cross-functional training and support as required
Act as a point of escalation
Qualifications
• Experience with ICF writing
• 1 year of clinical research experience in similar role at minimum or equivalent combination of education, training and experience is required.
• Ability to build strong relationships with stakeholders is essential, experience in sponsor facing role is strongly preferred
• Ability to lead the team on assigned projects
• Good analytical and organizational skills
Requirements for the employee
Candidates with education suit the position
University education (Bachelor's degree)
University education (Master's degree)
Postgraduate (Doctorate)
University education (Master's degree)
Postgraduate (Doctorate)
Language skills
English - Advanced (C1)
Number of years of experience
1
Advertiser
Brief description of the company
IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offices a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.
We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.
Whatever your career goals, we are here to ensure you get there!
We invite you to join IQVIA™
We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.
Whatever your career goals, we are here to ensure you get there!
We invite you to join IQVIA™
Number of employees
1000 and more employees
ID: 4026382
Dátum zverejnenia: 28.7.2021
2021-07-28
lokalita: Bratislava Pozícia: Regulatory Affairs Specialist, Support and Medical Activities Specialist Spoločnosť: IQVIA RDS Slovakia, s. r. o.
Základná zložka mzdy (brutto): 1 700 EUR/month