Senior Associate I, Tmf Operations

hace 3 semanas

Ciudad de México Worldwide Clinical Trials A tiempo completo

**Requisition Number**7564**

**Employment Type**:Regular**

**Who we are**

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.

**Why Worldwide**

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 Senior Associate I 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**
- Perform RMC Lead Activities for 1-3 Studies.
- Support TMF set-up, coordinate ‘Requests for Sites to be added in eTMF’ between Project. Teams (PT) and eTMF administrators; review eTMF access and coordinate updates, as necessary.
- Maintain Sciforma resources and tasks up to date.
- Communicate directly with multiple Project Team members to assess project needs relevant to the TMF.
- Provide Subject Matter Expert (SME) support for Project Teams and Sponsor related to TMF.
- Oversee the QC process and makes sure the RMC is on track (compliant with timelines and documentation) and follow up on non-compliance accordingly.

**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

**Your experience**
- University Degree preferred ( Life Science desirable )
- Up to 1-2 year of relevant experience
- Knowledge of working within a highly regulated industry (desirable)

**Why Worldwide**

We love knowing that someone is going to have a better life because of the work we do.

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