Multiple TMF Specialist Vacancies – OrciMed Life Sciences

TMF Specialist Vacancies – OrciMed Life Sciences

OrciMed Life Sciences Private Limited is hiring for multiple TMF Specialist and Senior TMF Specialist positions within its TMF, Clinical Research Operations, and BioMetrics functions. Several vacancies are available for TMF Specialists suitable for early-career professionals with 2+ years of experience, along with Senior TMF Specialist roles for candidates with 4+ years of experience. These roles are open for UK and USA shifts with flexible working models including office-based, hybrid, and remote options. The openings are ideal for candidates seeking stable, compliance-driven careers in clinical research documentation and regulatory operations.

Company Overview

OrciMed Life Sciences Private Limited is a global clinical research and life sciences services organization supporting pharmaceutical, biotechnology, and healthcare companies across the clinical trial lifecycle. The organization is known for its strong expertise in Trial Master File management, clinical documentation, pharmacovigilance support, and biometrics services.

With a focus on regulatory compliance and quality-driven delivery, OrciMed supports global studies by aligning documentation practices with ICH-GCP, FDA, EMA, and international regulatory expectations. The company leverages advanced electronic TMF systems, including Veeva Vault TMF, to maintain inspection-ready documentation across multi-country clinical trials. Its consistent performance and domain expertise have positioned OrciMed as a trusted partner for sponsors and CROs, while offering professionals long-term career stability and exposure to global regulatory standards.

Job Role & Responsibilities

The TMF Specialist and Senior TMF Specialist roles are critical compliance positions that ensure the accuracy, completeness, and readiness of Trial Master Files throughout the clinical trial lifecycle.

Key Responsibilities

  • Managing Trial Master File documentation in line with ICH-GCP and regulatory guidelines
  • Performing hands-on activities within electronic TMF platforms such as Veeva Vault TMF
  • Conducting TMF quality reviews, reconciliation, and completeness checks
  • Supporting audit and inspection readiness activities
  • Coordinating with clinical operations, safety, pharmacovigilance, and biometrics teams
  • Managing safety reporting-related documents and Argus uploads
  • Ensuring timely filing, metadata accuracy, and document version control
  • Handling multiple studies and priorities under strict timelines
  • Supporting pharmacovigilance documentation activities when required

Role Levels

  • TMF Specialist: Minimum 2+ years of hands-on TMF experience
  • Senior TMF Specialist: Minimum 4+ years of advanced TMF and inspection-readiness experience

These roles contribute directly to regulatory compliance, data integrity, and the successful execution of global clinical trials.

Eligibility / Qualifications

Educational Qualification

  • Bachelor’s degree in a related field

Experience Requirements

  • TMF Specialist: 2+ years of relevant TMF experience
  • Senior TMF Specialist: 4+ years of relevant TMF experience

Skill Requirements

  • Hands-on experience with Trial Master File processes
  • Working knowledge of electronic TMF systems
  • Ability to manage multiple tasks under tight deadlines
  • Strong written and verbal communication skills
  • Knowledge of safety reporting documentation
  • Experience with Argus uploads

Preferred Skills

  • Pharmacovigilance documentation experience
  • Exposure to global or multi-region clinical trials

Eligible Courses (Comma-Separated)

BSc Life Sciences, BSc Biotechnology, BSc Clinical Research, BPharm, MPharm, MSc Clinical Research, MSc Biotechnology, PharmD, Bachelor’s in Health Sciences

Location & Salary

Work Location

UK and USA shifts

Office, Hybrid, and Remote work options available

Employment Type

Full-time

TMF Specialist Vacancies – OrciMed Life Sciences
TMF Specialist Vacancies – OrciMed Life Sciences

Application Process

Candidates who meet the eligibility criteria and are available for immediate joining are encouraged to apply.

How to Apply

Interested candidates should email their updated CV to:

careers@orcimedlifesciences.com

Applicants are advised to mention the role applied for in the subject line and highlight relevant TMF, safety documentation, and system experience in their resume.

FAQs

Who can apply for the TMF Specialist position?

Candidates with a bachelor’s degree and at least 2 years of relevant TMF experience are eligible.

What experience is required for Senior TMF Specialist?

A minimum of 4 years of hands-on TMF experience with inspection readiness exposure is required.

Are remote work options available?

Yes. Depending on project needs, office, hybrid, and remote work models are available.

Is experience with Veeva Vault TMF mandatory?

Experience with electronic TMF platforms such as Veeva Vault TMF is strongly preferred.

Are immediate joiners required?

Yes. Immediate joiners will be given preference due to urgent project requirements.

Summary Table

Company OrciMed Life Sciences Private Limited
Vacancies TMF Specialist, Senior TMF Specialist
Required Education BSc Life Sciences, BSc Biotechnology, BPharm, MPharm, MSc Clinical Research, PharmD
Experience 2+ Years (TMF Specialist), 4+ Years (Senior TMF Specialist)

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To apply for this job email your details to careers@orcimedlifesciences.com


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