Join Our Crew

Responsibilities Include

• Monitor the adherence to ICH/GCP Guidelines, regulatory requirements and CABA policies as it relates to the completeness and accuracy of the TMF at the study level by ensuring the required documents reside in the TMF as per the Study-Specific Master Plan and Master List and are always inspection ready.
• Work with TMF Study Lead and study team to define the TMF Plan and to build the Study Master list from the Toolkit – TMF Master List.
• Define expected documents for the study and maintain appropriate placeholder or Expected Document Lists in the eTMF system in collaboration with Study team .
• Work proactively and prospectively with TMF Contributors to ensure timely uploading of all Essential Documents in the TMF.
• Periodically perform risk-based quality reviews of the TMF content by utilizing metrics and reports to assess any missing documents and then following-up with the appropriate functional group or document owner to mitigate, as per established review schedule.
• Resolve noncompliance with overdue quality review findings and overdue “In-Progress” eTMF documents, which will improve the accuracy of the TMF.
• Monitor and identify TMF trends and escalate concerns to management.
• At study completion, ensure the TMF is ready to be archived.
• Coordinate the long-term storage archival of original documents and maintain document integrity per retention policies.
• Manage complex export requests for Health Authorities and divestitures and independently solve technical issues.
• Leverage interpersonal and influencing skills to foster partnerships across multidisciplinary teams.
• Assist in overall change management and build collaborative relationships with cross-functional teams 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, and collaborate with peers in order to meet objectives or timelines in a rapidly changing environment.

Required Qualifications

Degree Requirements

• Minimum of Bachelor’s degree in a scientific or related discipline.
• Experience Requirements At least 3 years of TMF experience required, including experience in study start-up, maintenance, and closeout, and performing quality and completeness 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.

Key Competency Requirements

• Extensive knowledge and application of ALCOA+ standards, Good Clinical Practice, Good Documentation Practices, and International Council for Harmonization guidelines (E6(R2)).
• Subject Matter Expertknowledge of clinical trial documentation, TMF Reference Model, clinical trial activities and related terminology.
• Must have knowledge of Core, Country, and Site level essential documents.
• Must have ability to navigate eTMFsystem and show advance proficiency with Window Office tools.
• 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.
• Very strong communication and interpersonal skills, verbal and written, is required.

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