Operations Associate, Clinical Assessment - México - Worldwide Clinical Trials

Worldwide Clinical Trials

Empresa verificada

México

hace 5 días

Publicado por:

Rodrigo Fernández

Reclutador de talento para beBee

Descripción

Requisition Number7914**
Employment Type:Regular**
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.

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 Clinical Assessment Technologies does at Worldwide

The Operations Associate has primary responsibility for carrying out all daily aspects of the operational work related to rater selection, rater certification/qualification, rater training content, scale acquisition, surveillance maintenance, workbook/source document, for Worldwide Clinical Trials, Inc.

(WCT).

The Operations Associate is responsible for ensuring all assigned projects are conducted in a timely fashion and in a manner compliant with SOPs and ICH/GCP/regulatory guidelines.

The Operations Associate works under the direction of the Operations Manager, Clinical Assessment Technologies (CAT).

What you will do

Tasks may include but are not limited to:

Track the collection, entry, and distribution of rater experience qualification data
Review and may develop study specific rater training web portal specifications for portal readiness
Assist in coordinating logístical matters and prepare materials for Investigators' Meetings, which Associate may attend
Edit / format materials such as for rater training, including Excel spreadsheets, PowerPoint training slides, and Microsoft Word
Conduct scale management activities, such as obtaining scale licenses, translations, regulatory authorizations, and Sponsor approvals
Track incoming source documentation to ensure timeliness of source reviews and provide data to the Sponsor and study team
Communicate with research sites to ensure rater training and data surveillance plan guidelines are followed
Provide CAT data for the CAT Final Study Report completion and ensure proper formatting of document
Other Clinical Assessment Responsibilities
Assist Operations Manager to ensure budgetary demands are met per CAT project
Conduct CAT study material archiving

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.

What you will bring to the role

Highly organized, detail

- and service-oriented

Meets timelines consistently and be able to effectively work under pressure
Continuously open to constructive, developmental feedback
Skilled in written and verbal communication in order to clearly and concisely present information
High level of interpersonal skills in a fastpaced, deadline oriented, and changing environment
Able to manage multiple tasks and many administrative details in a fastpaced and constantly changing environment
High level of selfmotivation skills
High level ability to work in teams

Your experience

Preferred minimum of Associates degree
At least 1+ years clinical trial experience
Demonstrable knowledge of operational aspects Phase I-IV clinical
Ample knowledge of SOPs and ICH/GCP/regulatory guidelines
Competency working with data and numbers
Fluency in English (will be required to write, speak and understand English to conduct daytoday business)
The role requires travel domestically and internationally in order to attend key meetings. The global nature of the position may also require the incumbent to occasionally manage their time flexibly in order to be responsive to stakeholders in different time zones.

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

LI-CS1 #LI-Remote