TMF文件协调员 I-印度

Description
The TMF Document Coordinator I plays a key support role in maintaining the Sponsor’s Trial Master File (TMF) throughout the duration of a clinical trial. The TMF Coordinator I reviews and processes TMF records through quality control workflows to ensure they meet required quality, compliance, and regulatory standards before being approved into the TMF, following study-specific guidelines, SOPs, and ICH‑GCP requirements.
More specifically, the TMF Document Coordinator I must:

• Review TMF records for completeness, accuracy, and quality prior to approval.

• Classify records and assign appropriate metadata based on record type.

• Identify quality issues, issue pre‑approval queries, and coordinate with submitters to ensure timely resolution.

• Participate in TMF quality reviews and address assigned findings promptly.

• Assist in maintaining study milestones and expected document lists.

• Support the TMF Project Lead in generating monthly TMF metrics and related reports.

• Attend internal TMF Focus meetings to provide updates on TMF status, issues, and outstanding queries.

• Collaborate with project team members to resolve issues impacting TMF records.

Requirements

• College degree.

• Experience in clinical research within the biotechnology, pharmaceutical, or CRO industry.

• Intermediate proficiency in English.

• Computer skills and proficiency in Microsoft Word and Excel.

• Good organizational skills with the ability to manage multiple assignments.

• High attention to detail and accuracy.

• Ability to meet established timelines, expectations, and objectives.

• Adaptable and comfortable working in a multitasking environment.

• Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.

Our company
The work environment
At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.
In this position, you will be eligible for the following perks:

• Flexible work schedule

• Permanent full-time position

• Ongoing learning and development

Work location
Note that this opening is for a home-based position in India. Attendance at some meetings outside of regular business hours (primarily in the evening) is required.
About Indero
A Global Clinical Leader in Dermatology and rheumatology!
Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.
Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale.
Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.
Indero only accepts applicants who can legally work in India.
Originally posted on Himalayas