Ľutujeme, spoločnosť ponúkajúca danú pracovnú pozíciu ukončila zverejnenie ponuky na stránke.
Ďakujeme za porozumenie.
Zobraziť podobné ponuky
Ďakujeme za porozumenie.
Zobraziť podobné ponuky
Site Report Specialist (SRS)
IQVIA RDS Slovakia, s. r. o.
Place of work
Vajnorska 100/B, Bratislava
Vajnorska 100/B, Bratislava
Contract type
full-time
full-time
Information about the position
Job description, responsibilities and duties
PURPOSE
Review Site Visit Reports (SVRs) to ensure they meet or exceed quality standards and support goals of quality, subject safety,
data integrity and regulatory compliance. Use tools and techniques to ensure the efficient and effective review of Site Visit
Reports and their associated attachments, in compliance with Quintiles SOP, ICH/ GCP guidelines, and protocol requirements.
RESPONSIBILITIES
Manage and oversee a caseload of SVRs for assigned studies, ensuring compliance to the protocol, processes, timelines, Quintiles/applicable SOPs, and GCP guidelines. Review SVRs to ensure findings requiring corrective and/or preventative action plans are documented and followed up to resolution, to ensure high quality reports.
Serve as team lead within the project team for all SVR review activities and identifies and escalate CRA and /or site issues, relevant trends, and related risk factors to the project team and appropriate parties in a timely manner to optimize quality of project delivery.
Develop, in collaboration with Clinical Project Managers (CPMs) at project start-up and throughout the study, visit report annotations, guidelines, and assure accurate and timely completion of visit reports by CRAs through training and SOP compliance.
Ensure issues noted in the SVRs are escalated to the appropriate audience with recommended correction plans.
Lead regular meetings with CPMs to discuss any SVR review issues illustrative of quality/performance deficiencies across PIs/sites and CRAs. Assist the CPMs with identification of the trends emerging from the Issue Escalation Log.
Provide coaching and training to decrease the level of corrections/additions needed on reports.
Provide quality improvement support such as quality checks, data trending, providing back up support and mentoring and coaching of junior staff members.
May take on special project assignments related to function/corporate initiatives.
Review Site Visit Reports (SVRs) to ensure they meet or exceed quality standards and support goals of quality, subject safety,
data integrity and regulatory compliance. Use tools and techniques to ensure the efficient and effective review of Site Visit
Reports and their associated attachments, in compliance with Quintiles SOP, ICH/ GCP guidelines, and protocol requirements.
RESPONSIBILITIES
Manage and oversee a caseload of SVRs for assigned studies, ensuring compliance to the protocol, processes, timelines, Quintiles/applicable SOPs, and GCP guidelines. Review SVRs to ensure findings requiring corrective and/or preventative action plans are documented and followed up to resolution, to ensure high quality reports.
Serve as team lead within the project team for all SVR review activities and identifies and escalate CRA and /or site issues, relevant trends, and related risk factors to the project team and appropriate parties in a timely manner to optimize quality of project delivery.
Develop, in collaboration with Clinical Project Managers (CPMs) at project start-up and throughout the study, visit report annotations, guidelines, and assure accurate and timely completion of visit reports by CRAs through training and SOP compliance.
Ensure issues noted in the SVRs are escalated to the appropriate audience with recommended correction plans.
Lead regular meetings with CPMs to discuss any SVR review issues illustrative of quality/performance deficiencies across PIs/sites and CRAs. Assist the CPMs with identification of the trends emerging from the Issue Escalation Log.
Provide coaching and training to decrease the level of corrections/additions needed on reports.
Provide quality improvement support such as quality checks, data trending, providing back up support and mentoring and coaching of junior staff members.
May take on special project assignments related to function/corporate initiatives.
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)
Other knowledge
Business correspondence - Advanced
Microsoft Word - Advanced
Microsoft Excel - Advanced
Microsoft PowerPoint - Advanced
Microsoft Outlook - Advanced
Microsoft Word - Advanced
Microsoft Excel - Advanced
Microsoft PowerPoint - Advanced
Microsoft Outlook - Advanced
Personality requirements and skills
In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Through knowledge and understanding of the Clinical monitoring processes and sound knowledge of clinical trial system and applications
Demonstrated skill in understanding and executing complex study designs as well as multiple studies
Strong written and verbal communication skills.
Effective time management and organizational skills, and the ability to manage competing priorities
Ability to work independently with strong analytical and problem solving skills
Demonstrated ability to work across cultures and geographies with a high awareness and understanding of cultural differences
High quality orientation, with a focus on attention to detail
Effective mentoring skills
Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor's degree in a healthcare or other scientific discipline or educational equivalent and 5 years of Clinical Research experience, including a minimum of 2 years on-site monitoring experience; or equivalent combination of education, training and experience.
Fluent in English, both spoken and written.
PHYSICAL REQUIREMENTS
Extensive use of keyboard requiring repetitive motion of fingers.
Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
Regular sitting for extended periods of time.
May require occasional travel.
Through knowledge and understanding of the Clinical monitoring processes and sound knowledge of clinical trial system and applications
Demonstrated skill in understanding and executing complex study designs as well as multiple studies
Strong written and verbal communication skills.
Effective time management and organizational skills, and the ability to manage competing priorities
Ability to work independently with strong analytical and problem solving skills
Demonstrated ability to work across cultures and geographies with a high awareness and understanding of cultural differences
High quality orientation, with a focus on attention to detail
Effective mentoring skills
Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor's degree in a healthcare or other scientific discipline or educational equivalent and 5 years of Clinical Research experience, including a minimum of 2 years on-site monitoring experience; or equivalent combination of education, training and experience.
Fluent in English, both spoken and written.
PHYSICAL REQUIREMENTS
Extensive use of keyboard requiring repetitive motion of fingers.
Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
Regular sitting for extended periods of time.
May require occasional travel.
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: 2474550
Dátum zverejnenia: 23.2.2017
2017-02-23
lokalita: Bratislava Pozícia: Clinical Data Manager, Clinical Research Associate, Regulatory Affairs Specialist Spoločnosť: IQVIA RDS Slovakia, s. r. o.