IQVIA Hiring Clinical Process Specialists

Position Title: Clinical Process Specialist 1 – India

Company Name: IQVIA

Salary: Competitive, commensurate with experience

Company Address: Thane, Maharashtra

Detailed Job Description:

Role: Clinical Process Specialist 1

Industry Type: Clinical Operations

Department: Not specified

Employment Type: Full-Time

Role Category: Healthcare, Clinical Research

Education:

• UG: Bachelor’s degree in a healthcare or other scientific discipline or educational equivalent

Experience:

• 3 years of Clinical Research experience, including a minimum of 2 years of on-site monitoring experience.

Key Skills: Clinical Monitoring, Study Monitoring Plan, Clinical Trial Supplies, Data Analysis, Regulatory Compliance, Clinical Data Flow, Case Report Forms (CRFs), Quality Assurance, Information Technology, SOPs, GCP, Clinical Research.

Job Description:

As a Clinical Process Specialist 1, your responsibilities will include:

Essential Functions:

• Drafting and updating the study monitoring plan for Sponsor studies/protocols.
• Handling the preparation, distribution, filing, and archiving of study-related logs and forms.
• Assisting with periodic reviews of study files for accuracy and completeness.
• Supporting the preparation, handling, and distribution of Clinical Trial Supplies and tracking information.
• Developing, preparing, and maintaining the Global study performance dashboard by acquiring data from primary or secondary sources.
• Assisting the Study team in various phases, such as planning, maintenance, and closeout activities, by providing detailed data analysis in the form of reports.
• Supporting the project team to mitigate risks for high-risk trials by providing detailed analysis reports.
• Accurately updating and maintaining the required data in systems/tools within provided timelines.
• Collaborating with stakeholders to prioritize business and information needs.
• Responding to information requests from different stakeholders.
• Resolving discrepancies in data and obtaining further details for incomplete information.
• Identifying, analyzing, and interpreting trends or patterns for various metrics.
• Analyzing future and current end-user requirements to improve clinical operations.
• Engaging in on-the-job training, quality improvement initiatives, and departmental orientation.
• Tracking monthly retrospective quality issues for internal team members.
• Collaborating with Information Technology and clinical staff to support defined business needs.
• Designing clinical and administrative reports.
• Developing and analyzing systems to obtain necessary output for specific requirements.
• Performing administrative tasks to support team members with clinical trial execution as needed.
• Advocating compliance with all standard operating procedures.
• Assisting with tracking and management of Case Report Forms (CRFs), queries, and clinical data flow.
• Meeting with Sponsor representatives/Trail Managers and providing support on study-related activities.
• Assisting in eTMF activity, including filing/initial QC and classification of documents into TMF, performing detailed quality checks of documents uploaded into the TMFs.
• May be assigned the role of systems expert, guiding teams on using systems, creating guidance documents, updating trainings relevant to the systems, and relaying the trainings to the team, and being available to address queries for the teams.
• Providing Subject Matter Expert (SME) support/training and development.
• Responsible for the review and finalization of reports submitted by CRA within set timelines by applying Good Clinical Practice (GCP) and applicable protocol knowledge.

Qualifications:

• Bachelor’s Degree in a healthcare or other scientific discipline or educational equivalent.
• 3 years of Clinical Research experience, including a minimum of 2 years of on-site monitoring experience.