Who we are

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of over 3,000 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

What you will do

The Team Lead, TMF Operations is responsible for the processing, maintaining and archiving of all essential documents in compliance with the relevant Standard Operating Procedures, country regulations and industry best practice. The Team Lead will drive the delivery of Project Team objectives in ensuring the management of the essential documents. This is a global role and will require working with Worldwide Project Team members, Sponsors, 3rd Party Clinical Research Organizations and Quality Assurance.

RESPONSIBILITIES:

• Fulfil the "TMF Approver" and/or "TMF QC Reviewer" roles as defined by the relevant Standard Operation Procedure(s) (SOP)
• Deputize for "TMF Process Owner" where necessary
• Will act as “RMC Lead” on a number of Project Teams
• Serve as subject matter expert on Records Management Compliance processes
• Ability to identify roadblocks to a deliverable completion and effectively brings them to line managers for resolution
• Process Trial Master File (TMF) documents for multiple studies both in an electronic and hard copy format
• Prepare periodic TMF Quality Control checklists for review by Project Team review
• Maintenance of TMF metrics and spreadsheets for assigned studies
• Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices
• Work with a variety of Electronic Document Management and electronic TMF Systems to review, classify and process Essential Documents
• Communicate directly with multiple Project Team members to assess project needs relevant to the TMF
• Escalate any TMF Quality issues in a timelines manner to relevant parties
• Provide regular updates on TMF Compliance to Project Teams and Sponsors as necessary
• Act as a mentor to junior members of the team
• Prepare and transmit TMF and other critical documents to the Sponsor in accordance with the relevant instructions
• Support regulatory inspections and Sponsor audits
• Provide leadership in promoting TMF Compliance and continual Inspection readiness

OTHER SKILLS AND ABILITIES:

• Able to escalate issues and offer solutions for resolution via process improvement suggestions
• Applies analytical skills to evaluate and interpret complex situations/problems using multiple sources of information
• Ability to maintain direct reports, mentor and train individuals, if required
• Display strong interpersonal skills in a fast-paced, deadline oriented, rapidly changing
• environment
• Exercise sound judgment and ability to identify decisions requiring supervisory approval
• Handle multiple, highly detailed tasks with exceptional accuracy
• Develops solutions to technical problems of moderate complexity
• Deliver advise to Project Team members on key TMF issues
• Demonstrate strong planning and organizational skills
• Demonstrate proficiency in Microsoft Word and Excel
• Develop proficiency in use of an electronic document repository
• Understanding and adherence to corresponding Worldwide and sponsor standard operating
• procedures
• General understanding of clinical research principles and processes

REQUIREMENTS:

• University Degree preferred (Life Science desirable)
• Combination of education plus 5-8 years of relevant experience
• In depth knowledge of ICH GCP
• Experience in supporting GCP inspections (e.g., FDA, PMDA, EMA, Bfarm, MHRA, etc.)
• Experience of Document Management and/or eTMF solutions (e.g. Veeva, Trial Interactive, Documentum, etc.)
• Working knowledge of working within highly regulated industries (desirable)

Why Worldwide

At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it - because it does.Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.

Interested in hearing more about Worldwide or our roles? Check out our careers page at www.worldwide.com/careers!