IQVIA Biotech is seeking a Clinical Safety Specialist with at least 2 years of clinical trial case processing experience working in Argus:
BASIC FUNCTION:
Delivers Safety Management Department services according to ICH-GCP guidelines, regulatory requirements and IQVIA Biotech SOPs and/or project specific procedures.
Primary responsibilities include Processing and Reporting of incoming safety events and related data.
Assists Safety Management Leads with select tasks as assigned with supervision.
May serve as Safety Management Lead or backup Lead on studies/programs that are simple to moderate in scope of work.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
Safety Case Processing tasks including, but not limited to:
Triaging tasks as applicable for assigned projects
Reviewing incoming safety information for completeness and accuracy
Tracking and data entry
Writing clinical narratives
Generating queries
Contacting sites for missing and/or unclear information
Performing QC of cases and document results as applicable
Generating regulatory reports
Support monitoring of the safety database workflow, ensuring that case report timelines and deliverables are met
Safety Management Lead tasks including but not limited to:
Assisting in Safety Management start-up process including development of Safety Management Plan, SAE form, etc.
Attendance at team and client meetings
Reconciliation
Generating metrics
In collaboration with study safety manager, supports compliance with client budget and proactively escalates potential scope changes or noncompliance with cost or time allocation to department Manager.
May assist with bid defenses or other presentations.
May mentor and/or train new Safety Management staff.
Communicates with the client or internal stake holders as applicable.
Performs other related duties as assigned or requested by department management.
KNOWLEDGE, SKILLS AND ABILITIES:
In depth knowledge of clinical research process and medical terminology.
Able to identify, analyze and problem solve moderately complex issues and trends with guidance and support from senior staff.
Excellent written and verbal communication skills. Able to express complex ideas.
Positive attitude and ability to interact with all levels of staff to successfully coordinate and execute Safety Management department activities.
Able to develop knowledge of the disease under study. Able to discuss simpler aspects of the disease process with site personnel and colleagues.
Able to develop knowledge of protocol, regulatory requirements and company SOPs. Familiar with matrix team structure and phases of research. Able to identify and document regulatory non-compliance and any issues involving subject safety.
Good organizational and interpersonal skills.
Ability to reason independently to assess and recommend specific solutions in a clinical setting.
Attention to detail. Able to identify and resolve discrepancies on SAE reports and case report forms.
Understands electronic data capture including basic data processing functions.
Understands current ICH/ GCP guidelines applicable to the conduct of clinical research.
Demonstrates professionalism and presents a positive image of the company.
Prioritizes time effectively based on project needs. Consistently meets deadlines. Seeks management input with any difficulties in establishing priorities.
Identifies personal career development goals and opportunities related to current job. Solicits and applies performance feedback.
Demonstrates commitment, dedication, cooperation, positive behavior, adaptability and flexibility with changes in responsibilities and duties.
Demonstrates honesty and integrity in dealing with others. Works effectively with different types of people. Accepts constructive feedback without becoming defensive.
Seeks input from others when faced with a difficult situation. Makes sound decisions within the scope of responsibility. Focuses on resolving problems rather than placing blame.
Establishes and maintains effective relationships with customers (internal and external) and gains their trust and respect. Provides customers with complete and accurate information. Maintains a high energy level when interacting with customers. Acts with the customer in mind.
Able to work independently and identify issues and solutions proactively with guidance and mentorship from senior level staff and/or Safety Management.
CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
Very limited physical effort required to perform normal job duties.
Ability to travel domestically and internationally.
MINIMUM RECRUITMENT STANDARDS:
Bachelor’s Degree in one of the life sciences or clinical research and/or a licensed healthcare professional required.
Minimum of 2 years of experience in clinical trial safety processing.
Equivalent combination of relevant education and experience.
Computer literacy and experience working with a safety database (Argus preferred), Microsoft Office (Word, Excel) required.
Knowledge of electronic data capture preferred.
Excellent verbal and written communication skills required.
Excellent interpersonal and organizational skills required.
Ability to work independently, prioritize effectively and work in a matrix team environment required.
Ability and willingness to travel domestically and internationally as required; ability to rent automobile.
CLASSIFICATION (US):
This position is classified as exempt from the Fair Labor Standards Act; employees are not eligible for overtime compensation.
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IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
