INTELLISWIFT INC
Position:
Scientific - eTrial Master File Senior Analyst
Department:
Research and Development/Global Clinical Compliance and Continuous Improvement/Global Clinical Documents, Submissions and Disclosure
To deliver technical expertise in the Electronic Trial Master File (eTMF), provide support for all clinical trials throughout the lifecycle of the trial, and support inspection readiness goals in compliance with ICH/GCP guidelines. Work closely with Global Trial Managers and TMF Study Leads to support the completeness of the TMF.
Key Responsibilities:
Ensure accuracy at the document level in the eTMF for all Client-managed studies and CRO-managed studies in the Client eTMF, collaborating with study teams and TMF Study Leads.
Monitor adherence to ICH/GCP Guidelines, regulatory requirements, ALCOA+ Principles, and Client policies regarding the completeness and accuracy of the TMF.
Ensure proper classification and accuracy of required metadata in the TMF as per the Study-Specific Master Plan and Master List, ensuring inspection readiness at all times.
Manage complex technical tasks within the eTMF, including template creation and management, controlled document templates, and generating complex ad hoc TMF reports.
Demonstrate decision-making abilities, deliver on commitments, share knowledge, acknowledge others' achievements, and collaborate with peers to meet objectives in a rapidly changing environment.
Exhibit knowledge of critical documents to perform Quality Validation checks on documents that have undergone a quality review.
Make sound business decisions based on guidance documents and experience regarding the eTMF work involving critical or complex documents.
Participate in reviewing and updating documents to reflect industry standards and regulations, ensuring easy retrieval during regulatory inspections.
Exhibit project management skills by working closely with study teams to achieve goals and meet success criteria within specified timelines.
Display good time management skills, efficiently producing deliverables, meeting timelines, and prioritizing workload to meet business goals.
Provide support for TMF implementation, internal audits, and regulatory inspections.
Minimum Requirements: Minimum of Bachelor's degree in a scientific or related discipline.
At least 5 years of TMF experience required, including experience in study start-up, study maintenance, and document quality reviews. Relevant experience in clinical trials related roles (i.e., clinical operations and project management) is desirable, along with previous experience managing projects and handling concurrent tasks in a fast-paced environment.
#J-18808-Ljbffr
Scientific - eTrial Master File Senior Analyst
Department:
Research and Development/Global Clinical Compliance and Continuous Improvement/Global Clinical Documents, Submissions and Disclosure
To deliver technical expertise in the Electronic Trial Master File (eTMF), provide support for all clinical trials throughout the lifecycle of the trial, and support inspection readiness goals in compliance with ICH/GCP guidelines. Work closely with Global Trial Managers and TMF Study Leads to support the completeness of the TMF.
Key Responsibilities:
Ensure accuracy at the document level in the eTMF for all Client-managed studies and CRO-managed studies in the Client eTMF, collaborating with study teams and TMF Study Leads.
Monitor adherence to ICH/GCP Guidelines, regulatory requirements, ALCOA+ Principles, and Client policies regarding the completeness and accuracy of the TMF.
Ensure proper classification and accuracy of required metadata in the TMF as per the Study-Specific Master Plan and Master List, ensuring inspection readiness at all times.
Manage complex technical tasks within the eTMF, including template creation and management, controlled document templates, and generating complex ad hoc TMF reports.
Demonstrate decision-making abilities, deliver on commitments, share knowledge, acknowledge others' achievements, and collaborate with peers to meet objectives in a rapidly changing environment.
Exhibit knowledge of critical documents to perform Quality Validation checks on documents that have undergone a quality review.
Make sound business decisions based on guidance documents and experience regarding the eTMF work involving critical or complex documents.
Participate in reviewing and updating documents to reflect industry standards and regulations, ensuring easy retrieval during regulatory inspections.
Exhibit project management skills by working closely with study teams to achieve goals and meet success criteria within specified timelines.
Display good time management skills, efficiently producing deliverables, meeting timelines, and prioritizing workload to meet business goals.
Provide support for TMF implementation, internal audits, and regulatory inspections.
Minimum Requirements: Minimum of Bachelor's degree in a scientific or related discipline.
At least 5 years of TMF experience required, including experience in study start-up, study maintenance, and document quality reviews. Relevant experience in clinical trials related roles (i.e., clinical operations and project management) is desirable, along with previous experience managing projects and handling concurrent tasks in a fast-paced environment.
#J-18808-Ljbffr