Trial Master File Associate

1 week ago

Mumbai, India BIORASI LLC Full time

**We are Growing** Let us support your career journey the Biorasi way. Innovative, Collaborative, Dynamic and Evolving. Capitalizing on your strengths while encouraging work-life balance. Biorasi is an award-winning, customer-focused, full-service clinical research organization, and we are unlike any CRO you’ve ever heard of.

Biorasi is looking for top performers who are as passionate about clinical research as we are - clinical trial veterans and industry newcomers who will thrive in our fast-paced environment and help us drive new therapies to patients. Here is your chance to become a vital part of a growing global company in the expanding clinical research industry.

Start your career journey at Biorasi today with our newest opportunity
- ** Trial Master File Associate**

**Overview**
- We are international: Our headquarters is in Aventura, Florida. Other locations are Germany, India, Russia, and Ukraine.
- Our work culture includes: teamwork, hands-on mentality, flexibility, and open communication.
- Development and worklife balance: We want our employees to develop personally as well as professionally

**Your Responsibilities**
- Review, classify, and process Trial Master File (TMF) documents for multiple studies both in an electronic and hard copy format in a timely manner.
- Support the set-up, structure, maintenance, and closure of TMF.
- Scan, import, code, and index documents into the electronic Trial Master File and review for quality on an ongoing basis.
- Escalate any TMF Quality issues related to completeness and quality of documents (paper and electronic) in a timely manner to relevant parties.
- Prepare and transmit TMF and other critical documents to the Sponsor in accordance with the relevant instructions.
- Assists the Project Manager, Clinical Trial Manager and other functional leads (e.g., data management; biostats; medical writing, supply chain, etc.) to ensure TMF documentation is submitted/published in a timely manner and with high quality in order to maintain the TMF in an audit/inspection-ready state.
- Perform periodic quality check as per SOP.
- Attend and assist in preparing monthly TMF status meetings, risks, issues, and associated actions for assigned projects
- Support the study team in preparation, conduct, and follow up of internal and/or external audits/inspections.
- Archive all paper files and maintain an ongoing Inventory list of all received files in timely manner.
- Partake in regular team meeting/ teleconferences, as applicable.
- Communicate any out-of-scope issues to TMF Specialist as soon as identified.
- Other duties as assigned.
- Bachelor’s Degree in biomedical sciences or related scientific discipline; or sufficient work experience in related field
- Fluent English (oral and written) and applicable local language.
- Zero to two years of experience in clinical research. Experience in eTMF management preferred.
- May possess some data collection, indexing and editing skills, including ability to adhere to standardized document naming conventions
- Experience with the Trial Master File Reference model preferred
- Understanding of records management best practices
- Excellent verbal and written communication skills
- Excellent organizational, multi-tasking and time management skills
- Knowledge and experience with MS Office suite (Word, PowerPoint and Excel)
- Knowledge of International, local regulations and ICH GCP guidelines.

We strive to provide our employees and their families with benefits that are thoughtfully designed to enhance your health and well-being. Our employees enjoy summer half-day Fridays, paid time off to include vacation, holidays, and sick days, medical, dental, vision, life insurance, short-term and long-term disability, company matching 401K, employee bonus programs, career growth, training and development.

Biorasi is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Biorasi is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

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