Clinical Trials Manager- Early Development Oncology
Gilead SciencesSalary not specified
Full Time
Mid-level (3 to 4 years), Senior (5 to 8 years)
Not SpecifiedCompensation
Entry Level & New Grad, Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
Clinical Research, PharmaceuticalsIndustries
Requirements
- High School Diploma or equivalent
- 3 years administrative support experience
- Equivalent combination of education, training and experience
- Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint
- Written and verbal communication skills including good command of English language
- Effective time management and organizational skills
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients
- Awareness of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as provided in company training
- Knowledge of applicable protocol requirements as provided in company training
Responsibilities
- Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines
- Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures
- Assist with periodic review of study files for completeness
- Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information
- Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow
- Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation
- May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What qualifications are required for the Clinical Trial Assistant role?
A High School Diploma or equivalent is required, along with 3 years of administrative support experience or an equivalent combination of education, training, and experience. Key skills include computer proficiency in Microsoft Word, Excel, and PowerPoint, strong written and verbal communication in English, effective time management, organizational skills, and the ability to maintain working relationships.
What is the salary or compensation for this position?
This information is not specified in the job description.
Is this a remote position or does it require office work?
This information is not specified in the job description.
What does IQVIA do as a company?
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries, creating intelligent connections to accelerate the development and commercialization of innovative medical treatments.
What experience makes a strong candidate for this Clinical Trial Assistant role?
Candidates with 3 years of administrative support experience, proficiency in Microsoft Office tools, strong organizational and communication skills, and awareness of GCP and ICH guidelines from company training will stand out.
IQVIA
Advanced analytics and clinical research services
About IQVIA
IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.
Durham, North CarolinaHeadquarters
1998Year Founded
$3,526MTotal Funding
POST_IPO_EQUITYCompany Stage
Cybersecurity, Biotechnology, HealthcareIndustries
10,001+Employees
Risks
Rapid advancement of cancer vaccines may disrupt traditional clinical research models.
Proliferation of disparate technological solutions causes technology overload in clinical trials.
Generative AI technologies face challenges in adoption due to data privacy concerns.
Differentiation
IQVIA leverages advanced analytics and big data for life sciences solutions.
The company offers privacy-enhancing technologies to protect individual patient data.
IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.
Upsides
Increased adoption of decentralized clinical trials enhances patient-centric study designs.
AI-driven drug discovery accelerates identification of potential drug candidates.
Expansion of telemedicine facilitates remote patient monitoring and data collection.
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