Job Details

ID #45981501
State New Jersey
City Lawrenceville
Job type Contract
Salary USD BASED ON EXPERIENCE BASED ON EXPERIENCE
Source Alpha Consulting Corp.
Showed 2022-09-25
Date 2022-09-24
Deadline 2022-11-22
Category Science/biotech
Create resume

ETrial Master File Analyst With Veeva Vault Reporting

New Jersey, Lawrenceville, 08648 Lawrenceville USA

Vacancy expired!

eTRIAL MASTER FILE ANALYST WITH VEEVA VAULT REPORTING LAWRENCEVILLE, NJ Hybrid 50%. Project Description:

  • 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/Google Cloud Platform guidelines.
  • Work closely with Global Trial Managers and TMF Study Leads to support the completeness of the TMF .
  • Ensuring accuracy at the document level in the eTMF for all company-managed studies and CRO-managed studies in the company eTMF, with the study teams and TMF Study Leads, Global Trial Managers and/or Subject Matter Experts for eTMF .
  • Monitor the adherence to ICH/Google Cloud Platform Guidelines, regulatory requirements, ALCOA+ Principles and company 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 other 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.
Required Skills:
  • 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/Google Cloud Platform guidelines.
  • Experience managing clinical content in a records management system or electronic Trial Master File system.
  • Veeva Vault reporting experience.
  • Ideally looking for candidates with metrics and reporting skills within Veeva Vault.
  • Strong Excel (macros, pivot tables, etc.) .
  • Have very strong communication skills, verbal and written.
This 12+month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: ALPHA'S REQUIREMENT #22-02670 MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

Vacancy expired!

Subscribe Report job