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Clinical Trial Registration Senior Specialist

3 years
Not Disclosed
10 Nov. 20, 2025
Job Description
Job Type: Hybrid Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Clinical Trial Registration Senior Specialist – Hyderabad, India

Category: Clinical Research | Location: Hyderabad, Telangana
Experience Required: Minimum 3 years

About the Role

Bristol Myers Squibb (BMS) is seeking a highly skilled Clinical Trial Registration Senior Specialist to support clinical trial transparency and regulatory compliance activities across global public registries. This role is positioned within the Global Development Operations – Trial Delivery Support (TDS) / Trial Risk & Integrity Management (TRIM) / Clinical Trial Transparency & Submission division.

The specialist will oversee the preparation, submission, and maintenance of clinical trial registration records to ensure timely and accurate disclosures in alignment with global regulatory guidelines.


Key Responsibilities

  • Manage and execute protocol registration activities across global registries, including ClinicalTrials.gov and EU registries, ensuring high-quality and timely submissions.

  • Collaborate with cross-functional clinical teams such as Global Trial Managers, Operations Leads, Statisticians, Clinical Trial Physicians, Clinical Scientists, Development Leads, and Patent functions to ensure all records are accurate and consistent with approved clinical protocols.

  • Provide ongoing maintenance for assigned registry records to ensure continued accuracy and compliance with NIH and regulatory standards.

  • Submit updates and amendments to public registries within mandated timelines.

  • Maintain and update study trackers and reporting dashboards on a weekly basis.

  • Educate internal stakeholders on regulatory criteria, NIH review expectations, and registry submission requirements.

  • Support trial registrations across additional global public registries as required.

  • Contribute to process enhancements, quality improvement initiatives, and operational best practices.


Qualifications

Educational Requirements

  • Bachelor’s degree in a Science-related field (Life Sciences preferred).

Experience Requirements

  • Minimum 3 years of professional experience, preferably within the biopharmaceutical, CRO, or clinical research industry.

  • Exposure to clinical research, clinical trial transparency, quality, regulatory, or compliance functions is highly desirable.

  • Experience with clinical trial execution processes or regulatory data submissions strongly preferred.


Key Competencies

  • Strong analytical and advanced Excel skills.

  • Ability to collaborate across multi-functional teams and diverse therapeutic areas.

  • Excellent written and verbal communication skills.

  • Strong organizational capabilities with the ability to manage multiple priorities.

  • Proven ability to work independently, proactively seek support, and contribute to new initiatives.


Why Join Bristol Myers Squibb

At BMS, employees work on innovative, meaningful projects that contribute directly to transforming patients’ lives through science. The company fosters professional growth through unique opportunities, flexible work models, and a supportive environment rooted in the values of innovation, accountability, integrity, inclusion, and scientific excellence.


Work Model

BMS follows a structured occupancy framework:

  • Site-essential roles: 100% onsite.

  • Site-by-design roles: Hybrid model with minimum 50% onsite.

  • Field-based and remote-by-design roles: Travel required as needed for business operations.

This role follows the occupancy guidance aligned with its responsibilities.