Senior Associate I, Trial Master File (TMF) Operations

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, 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 a Senior Associate, TMF Operations does at Worldwide Clinical Trials

The Senior Associate, 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 practices. The Senior Associate will support the delivery of department objectives in ensuring the management's essential documents. This is a global role and will require working with Worldwide Project Team members and Quality Assurance.

RESPONSIBILITIES:

• Fulfill 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
• 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 the 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
• 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 and Sponsor audits, where necessary
• Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

OTHER SKILLS AND ABILITIES:

• Possess data collection, indexing, and editing skills, including the ability to adhere to standardized
• document naming conventions
• Possess excellent written and verbal communication skills to clearly and concisely present
• information
• Work independently and with teams and can execute tasks works under general direction, seeks assistance as needed
• 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 advice to Project Team members on key TMF issues
• Demonstrate strong planning and organizational skills
• Demonstrate proficiency in Microsoft Word and Excel
• Develop proficiency in the 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 2-5 years of relevant experience
• Knowledge of working within a highly regulated industry (desirable) or experience in the CRO/Pharmaceutical Company Industry

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!

#LI-HD1

#LI-Remote

##LI-HD1

#LI-Rete