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Associate Site Report Specialist / Site Report Specialist (ASRS/SRS)
IQVIA RDS Slovakia, s. r. o.
Place of work
Zámocká 34, Bratislava region
Zámocká 34, Bratislava region
Contract type
full-time
full-time
Information about the position
Job description, responsibilities and duties
PURPOSE
Apply clinical research expertise to provide project related assistance across complex and multiple project(s), sites and project teams. Lead teams functionally, where assigned, including awareness of scope of work, budget, and resources. Ensure all work is conducted in accordance with SOPs, policies and practices, good clinical practices and applicable regulatory requirements and meets quality and timeline metrics. Mentor/ coach Clinical Process Associate/Specialist colleagues.
RESPONSIBILITIES
Perform complex processes and tasks that eventually result in high quality deliverables that are completed according to service level agreements (SLAs) and within project timelines
Establish and maintain effective project/ site communications
Create and maintain relevant project documents/ trackers
Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information
Review, evaluate and recommend modifications to designated processes
Oversee and participate in document management (creation, review, maintenance, storage, as applicable)
Participate in (study) team meetings and implement action items
Collaborate with the project lead/team members in creation/review of study documents including Quality manuals
Act as point of contact for assigned deliverables for specific customers or projects
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
Escalate quality issues to relevant stakeholders and/or line manager.
Coach junior clinical process associate/specialists
Apply clinical research expertise to provide project related assistance across complex and multiple project(s), sites and project teams. Lead teams functionally, where assigned, including awareness of scope of work, budget, and resources. Ensure all work is conducted in accordance with SOPs, policies and practices, good clinical practices and applicable regulatory requirements and meets quality and timeline metrics. Mentor/ coach Clinical Process Associate/Specialist colleagues.
RESPONSIBILITIES
Perform complex processes and tasks that eventually result in high quality deliverables that are completed according to service level agreements (SLAs) and within project timelines
Establish and maintain effective project/ site communications
Create and maintain relevant project documents/ trackers
Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information
Review, evaluate and recommend modifications to designated processes
Oversee and participate in document management (creation, review, maintenance, storage, as applicable)
Participate in (study) team meetings and implement action items
Collaborate with the project lead/team members in creation/review of study documents including Quality manuals
Act as point of contact for assigned deliverables for specific customers or projects
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
Escalate quality issues to relevant stakeholders and/or line manager.
Coach junior clinical process associate/specialists
Requirements for the employee
Candidates with education suit the position
Follow-up/Higher Professional Education
University education (Bachelor's degree)
University education (Master's degree)
Postgraduate (Doctorate)
University education (Bachelor's degree)
University education (Master's degree)
Postgraduate (Doctorate)
Educational Specialization
Life sciences
Language skills
English - Upper intermediate (B2)
Other knowledge
Business correspondence - Expert
Microsoft Excel - Advanced
Microsoft Outlook - Advanced
Microsoft PowerPoint - Advanced
Microsoft Word - Advanced
Microsoft Excel - Advanced
Microsoft Outlook - Advanced
Microsoft PowerPoint - Advanced
Microsoft Word - Advanced
Personality requirements and skills
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
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 Clinical Process Associate colleagues
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor's degree in life sciences or related field and min 4 years with relevant clinical research experience; or equivalent combination of education, training and experience
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.
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 Clinical Process Associate colleagues
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor's degree in life sciences or related field and min 4 years with relevant clinical research experience; or equivalent combination of education, training and experience
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.
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: 2155978
Dátum zverejnenia: 28.7.2015
2015-07-28
lokalita: Bratislava region Pozícia: Clinical Data Manager, Clinical Research Associate, Medical Advisor, Pharmacist, Quality Manager Spoločnosť: IQVIA RDS Slovakia, s. r. o.