Records Management Associate - Letchworth, United Kingdom - Bionical Emas

Bionical Emas

Verified Company

Letchworth, United Kingdom

3 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

A Career with Purpose
Bionical Emas is a global Clinical Research Organization (CRO) bringing life-changing medicines to patients around the world.

We combine Clinical Development, Clinical Trial Supply (CTS) and Early Access Programs (EAP) to deliver a unique, seamless service to our pharma and biotech clients.

At Bionical Emas, you will have the chance to develop your career while working with an outstanding team of people.

Our shared values create a unique culture that guides our actions and defines who we are. You will be a part of a welcoming, flexible, and supportive culture that values trust and belonging. We believe that creating opportunities for our people to develop their skills is crucial to our growth and success.

If you are inspired by changing the lives of patients all over the world, we'd love to hear from you.

About the Role

We are looking for a Records Management Associate who will provide support for Trial Master File activities to global clinical study teams.

This role will be responsible for performing data entry for site, country, and study level documents, and day-to-day support of TMF activities, which may include quality control (QC) and quality review of clinical documents, training on clinical document management and TMF business processes, and the eTMF system.

What will your job look like?

Perform key TMF review duties in accordance with the company guidelines and work instructions (e.g., TMF setup, quality management, reports, and metrics, TMF quality control (QC)/ quality assurance (QA) activities, etc.)
Ensure the TMF file structure follows applicable company approved TMF configuration, regarding ICH Guidelines for Good Clinical Practice, Good Documentation Practices and the TMF Reference Model
Ensures that all new and updated record information is accurately entered in the appropriate records management databases, and is maintained in accordance with the company eTMF and/or other electronic data room storage SOPs, processes, and data structure for inspection readiness under minimum supervision
Ensure customer requests for retrieval, reproduction, and refiling of requested records or electronic images (e.g., PDF, jpeg) are met in a timely manner
Classify and add metadata to uploaded documents in eTMF; may upload documents as required
Identify trends/patterns in quality issues for training purposes
Assist with activities for transfer, delivery, and offsite archival of TMF records as requested by management or the sponsor
May assist with audit/inspection preparation
May assist with reviewing updates to project TMF Plans, Filing Guidance, and Work Instructions

What will you need to succeed?

Bachelor's Degree (scientific discipline preferred) or equivalent preferred
Trial Master File experience preferred, but not required
Knowledge of clinical research concepts is helpful
Familiarity with an electronic Trial Master File platform is preferred

What will you get in return?

We want you to do your best work We care about our people's well-being, their personal development and providing a true work-life balance.

Our benefits are aligned with our culture and values and are intended to maximize your experience working for us. Here are some of the benefits you can expect from working for Bionical Emas.

25 days of vacation
Vacation days purchasing scheme
1 extra vacation day per each 3 years of service
Discretionary Annual Bonus
Sabbatical of 3 to 6 months (after 2 years of service)
1 volunteer day per year
Free food and beverages at all offices
Life Insurance
Health Insurance and Employee Assistance Programme
Employee Support Networks help us continue to build on our inclusive culture
Flexible and hybrid work
Training and Personal Development Program

Does this sound like you?

It is time to apply, and we can't wait to hear from you_

Even if you don't meet 100% of the requirements, be confident in yourself and don't hesitate to apply

We Are Bionical Emas

We Are Bionical Emas, where each person is unique. We celebrate individuality while encouraging our talents to work as a team. Together, we make a difference by powering an inclusive future for all. Be you, with us.

**Powering the patient journey