Associate I/II, TMF Operations
Location: Mexico City, Mexico
Requisition Number: 7277
Position Title: Associate II, TMF Operations
Who we are
Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers.
Our talented team of 3,000+ professionals spans 60+ countries. We are united in cause with our customers to improve the lives of patients through new and innovative therapies.
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!
What the Associate II does at Worldwide
The Associate II, TMF Operations is responsible for the processing, maintaining, and archiving of all essential documents in compliance with the relevant Standard Operating Procedures, ALCOA principles, country regulations and industry best practice. The Associate will support the delivery of department objectives in ensuring the management essential documents. This is a global role and will require working with Worldwide Project Team members.
What you will do
- Fulfil the "TMF Approver" and/or "TMF QC Reviewer" roles as defined by the relevant Standard Operation Procedure(s) (SOP) and working practices.
- Process, review, and resolve rejected Trial Master File (TMF) documents, for complex studies or Sponsor portfolio of studies both in an electronic and hard copy format.
- Prepare periodic TMF Quality Control checklists for review by Project Team review.
- 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
What you will bring to the role
- Possess data collection, indexing and editing skills, including ability to adhere to standardized document naming conventions
- Possess excellent written and verbal communication skills to clearly and concisely present information
- Display strong interpersonal skills in a fast-paced, deadline oriented, rapidly changing environment
- Handle multiple, highly detailed tasks with exceptional accuracy. Demonstrate strong planning and organizational skills
- Demonstrate proficiency in Microsoft Word and Excel
- Develop proficiency in use of an electronic document repository or eTMF. General understanding of clinical research principles and processes
- University Degree preferred ( Life Science desirable )
- Up to 1-2 year of relevant experience
- Knowledge of working within a highly regulated industry (desirable)
We love knowing that someone is going to have a better life because of the work we do.
Employment Type: Regular
Community / Marketing Title: Associate I/II, TMF Operations
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.
Location_formattedLocationLong: Mexican Federal District, MX