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Centralized Monitoring Lead
IQVIA RDS Slovakia, s. r. o.
Place of work
Vajnorská 100/B, Bratislava
Vajnorská 100/B, Bratislava
Contract type
full-time
full-time
Wage (gross)
Minimum salary from 1900 EUR/gross. Our offer to you may be higher based on your experience.*
Minimum salary from 1900 EUR/gross. Our offer to you may be higher based on your experience.*
Information about the position
Job description, responsibilities and duties
Join us on our exciting journey!
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 offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.
Primary Function:
Centralized Monitoring Lead (CML) partners with the Clinical Lead and local country Site Monitors in project execution. Provides centralized support to monitoring visits and site management for a variety of protocols, sites and therapeutic areas. Monitors study start-up, manages resources, performs ongoing risk assessment through data trending and analytics and proposes potential mitigating actions in a timely fashion. Leads team of Central Monitors(CM) and Clinical Analyst Support (CAS).
Roles & Responsibilities:
Study Start-up
Maintains Clinical Operations Plan . Supports development of iSite Pack template, KDPMP and other tools/templates for DTE studies. Works with relevant stake holders for set-up and activation of DTE Alert/Triggers dashboard.
Ensure the SSV Attributes and Monitoring Attributes are updated appropriately on QRPM. Request site monitor resources for site selection visits. Verifies training compliance and system access for the site management team involved during the study start-up.
LCA or designee informs the monitor of all site activation critical elements that should be obtained to ensure the successful and efficient conduct of the site selection activity.
Tracks site activation related critical elements on an ongoing basis before Site Initiation and keeps CL and Start-up Lead updated about the status of the site activation.
Study Initiations
Requests monitor resource for site initiation and site monitoring. Verifies training compliance and system access for the site management team (CRA, CM and CAS) involved in the study site initiations.
Coordinates with all stakeholders to start the site initiation activities once all site activation critical elements are obtained/resolved.
Study Maintenance
Closely works with Site Monitor and CL during study execution phase with respect to recruitment and compliance to Clinical Operation Plan. Perform ongoing risk assessment through data trending and analytics and proposes potential mitigating actions in a timely fashion. Supports CRA in management of Quality issues.
Manages DTE Alerts and other study specific triggers. Reviews status of action items and follow-ups with relevant team members for closure of action items. Escalates to Clinical Lead and PMA in case of significant delays in closure of action items if required.
Sample review of iSite Pack (DTE studies), closed and open action items, Site Level documents on TMF.
As applicable reviews Site Visit reports (for smaller studies with less than 20 reports per month)
Review the RM Dashboard and resolve any items that need attention (i.e., Resource Assignment Errors, Queried Requests, and Inactive Resources Still Assigned).
Manages resourcing and transition of study team members during execution phase. Provides training to Site Monitor, Central Monitor and Clinical Analyst Support if required.
Reviews and approves Investigator Payments.
Review and manages services requests received by CCO staff.
Provides study updates to Clinical Leads as per study requirements.
Study closeout
Reconciles action items, DTE alerts and study specific triggers.
Qualifications
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
Whatever your career goals, we are here to ensure you get there!
We invite you to join IQVIA™.
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 offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.
Primary Function:
Centralized Monitoring Lead (CML) partners with the Clinical Lead and local country Site Monitors in project execution. Provides centralized support to monitoring visits and site management for a variety of protocols, sites and therapeutic areas. Monitors study start-up, manages resources, performs ongoing risk assessment through data trending and analytics and proposes potential mitigating actions in a timely fashion. Leads team of Central Monitors(CM) and Clinical Analyst Support (CAS).
Roles & Responsibilities:
Study Start-up
Maintains Clinical Operations Plan . Supports development of iSite Pack template, KDPMP and other tools/templates for DTE studies. Works with relevant stake holders for set-up and activation of DTE Alert/Triggers dashboard.
Ensure the SSV Attributes and Monitoring Attributes are updated appropriately on QRPM. Request site monitor resources for site selection visits. Verifies training compliance and system access for the site management team involved during the study start-up.
LCA or designee informs the monitor of all site activation critical elements that should be obtained to ensure the successful and efficient conduct of the site selection activity.
Tracks site activation related critical elements on an ongoing basis before Site Initiation and keeps CL and Start-up Lead updated about the status of the site activation.
Study Initiations
Requests monitor resource for site initiation and site monitoring. Verifies training compliance and system access for the site management team (CRA, CM and CAS) involved in the study site initiations.
Coordinates with all stakeholders to start the site initiation activities once all site activation critical elements are obtained/resolved.
Study Maintenance
Closely works with Site Monitor and CL during study execution phase with respect to recruitment and compliance to Clinical Operation Plan. Perform ongoing risk assessment through data trending and analytics and proposes potential mitigating actions in a timely fashion. Supports CRA in management of Quality issues.
Manages DTE Alerts and other study specific triggers. Reviews status of action items and follow-ups with relevant team members for closure of action items. Escalates to Clinical Lead and PMA in case of significant delays in closure of action items if required.
Sample review of iSite Pack (DTE studies), closed and open action items, Site Level documents on TMF.
As applicable reviews Site Visit reports (for smaller studies with less than 20 reports per month)
Review the RM Dashboard and resolve any items that need attention (i.e., Resource Assignment Errors, Queried Requests, and Inactive Resources Still Assigned).
Manages resourcing and transition of study team members during execution phase. Provides training to Site Monitor, Central Monitor and Clinical Analyst Support if required.
Reviews and approves Investigator Payments.
Review and manages services requests received by CCO staff.
Provides study updates to Clinical Leads as per study requirements.
Study closeout
Reconciles action items, DTE alerts and study specific triggers.
Qualifications
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
Whatever your career goals, we are here to ensure you get there!
We invite you to join IQVIA™.
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 - Upper intermediate (B2)
Personality requirements and skills
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Bachelor's degree in life sciences or related field and min 2 years with relevant clinical research experience; or equivalent combination of education, training and experience
Advanced knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements; i.e., ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct. Familiarity with related systems and software’s utilized in clinical operations.
Strong written and verbal communication skills including good command of English language
Results and detail-oriented approach to work delivery and output
Good problem solving skills
Good planning, time management and prioritization skills
Ability to handle conflicting priorities
Attention to detail and accuracy in work
Good software and computer skills, including MS Office applications including but not limited to Microsoft Word, Excel and PowerPoint
Ability to establish and maintain effective working relationships with coworkers, managers and clients. Strong leadership skills
Ability to work across cultures and geographies with a high awareness and understanding of cultural differences
Act as a mentor for Central Monitor colleagues
*We are required by law to disclose basic wage component (minimum salary) for the advertised positions. We carefully consider your professional qualifications and experience in our compensation package and/or when offering you other positions.
Our goal is to pay our employee's fairly, with regard to the market situation and we are ready to welcome high-quality candidates in our team.
Bachelor's degree in life sciences or related field and min 2 years with relevant clinical research experience; or equivalent combination of education, training and experience
Advanced knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements; i.e., ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct. Familiarity with related systems and software’s utilized in clinical operations.
Strong written and verbal communication skills including good command of English language
Results and detail-oriented approach to work delivery and output
Good problem solving skills
Good planning, time management and prioritization skills
Ability to handle conflicting priorities
Attention to detail and accuracy in work
Good software and computer skills, including MS Office applications including but not limited to Microsoft Word, Excel and PowerPoint
Ability to establish and maintain effective working relationships with coworkers, managers and clients. Strong leadership skills
Ability to work across cultures and geographies with a high awareness and understanding of cultural differences
Act as a mentor for Central Monitor colleagues
*We are required by law to disclose basic wage component (minimum salary) for the advertised positions. We carefully consider your professional qualifications and experience in our compensation package and/or when offering you other positions.
Our goal is to pay our employee's fairly, with regard to the market situation and we are ready to welcome high-quality candidates in our team.
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: 3264043
Posting date: 24.9.2018
2018-09-24
location: Vajnorská 100/B, Bratislava Position: Clinical Research Associate Company: IQVIA RDS Slovakia, s. r. o.
Basic wage component (gross) and other rewards: Minimum salary from 1900 EUR/gross. Our offer to you may be higher based on your experience.*