Job Description

“This role is currently work-from-home and will move to the office environment after the COVID-19 restrictions are lifted.”

Job Description: 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 what is in the book of work, 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 deliverables include: ensuring accuracy at the document level in the eTMF for all Client-managed studies and CRO-managed studies in the Client eTMF, with the study teams and TMF Study Leads, Global Trial Managers and/or Subject Matter Experts for eTMF
• Monitor the adherence to ICH/GCP Guidelines, regulatory requirements, ALCOA+ Principles and Client policies as it relates to the completeness and accuracy of the TMF at the document level.
• Ensure that the documents are filed in the correct classification and that the required metadata is accurate and complete in the TMF as per the Study-Specific Master Plan and Master List and are inspection ready at all times.
• Manage complex and more technical tasks within the eTMF; including but not limited to: template creation and management, controlled document templates, system hard deletion process, creating complex ad hoc TMF reports for users, developing custom reports to generate metrics, developing or enhancing macros to streamline existing and new processes.
• Demonstrates ability to make decisions, deliver on commitments, share knowledge, acknowledge others achievements, and collaborate with peers in order to meet objectives or timelines in a rapidly changing environment
• Exhibit knowledge of critical and essential documents to be able to perform Quality Validation checks on documents that have had completed quality review.
• Ability to make sound business decisions based on evidence (guidance documents and Manual of Operations) and experience regarding the outcome of the eTMF work that is performed that involves critical or complex documents.
• Generate, organize, and deliver performance metrics for various functional areas within eTMF Operations
• Leverage interpersonal and influencing skills to foster partnerships across multidisciplinary teams.
• Assist in overall change management and build collaborative relationships with cross-functional team and third-party vendors.
• Participate in reviewing and updating documents to ensure that they are reflective of industry standards, applicable regulations and are easily retrieved following a regulatory inspection.
• Exhibit good project management skills that include working closely with the study teams to achieve goals and meet success criteria within specified timelines.
• Display good time management skills, the ability to produce deliverables efficiently, meet timelines, and prioritize workload to meet business goals.
• Provide support to TMF implementation, internal audits and regulatory inspections.
• Demonstrate ability to make decisions, deliver on commitments, share knowledge, acknowledge other’s achievements, and collaborate with peers in order to meet objectives or timelines in a rapidly changing environment.

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). Previous experience with independently managing projects and handling concurrent tasks in a fast-paced environment and delivering results within tight timelines is desirable.

Critical thinker: Utilizing an intellectually disciplined process of actively and skillfully conceptualizing, applying, analyzing, synthesizing and/or evaluating information gathered from, or generated by, experience, reasoning or communication that will be instrumental in the decision-making process for quality review.
Demonstrated working knowledge of the pharmaceutical industry including ICH/GCP guidelines. Experience managing clinical content in a records management system or electronic Trial Master File system. Have very strong communication skills, verbal and written.

How to Apply

Job Types: Temporary.

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