Clinical Trial Registration Specialist at Bristol-Myers Squibb

Hyderabad, Telangana, India

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, HealthcareIndustries

Requirements

Bachelor’s degree, preferably in a Science-related field
Minimum of 3 years overall work experience, preferably in a biopharmaceutical or CRO company
Work experience in quality, regulatory, compliance, clinical research or drug development highly desirable
Work experience in clinical trial transparency or clinical trial execution, or work experience related to quality and compliance in clinical research preferred
Demonstrated Excel and analytical skills
Ability to work in a multi-functional team and across multiple therapeutic areas
Demonstrated ability to work independently and seek out support when needed
Written and oral communication skills
Strong organizational skills with the ability to multitask and prioritize, and take on new initiatives and improvement efforts

Responsibilities

Drives the processes for assigned protocol registration activities, resulting in timely, high-quality information posted on clinical trial registries (Clinicaltrials.gov and EU PAS)
Liaises with clinical team reviewers (Global Trial Managers, Operations Leads, Statisticians, Clinical Trial Physicians, Clinical Scientists, Development Leads, Patent Attorneys) and other stakeholders on all assigned trials to ensure trial registrations are accurate, consistent with the protocol and other source data, and reported in adherence to NIH guidelines
Provides maintenance support to CT Registration Lead for assigned records, to ensure the consistent accuracy of information disclosed on Clinicaltrials.gov
Submits registration updates to Clinicaltrials.gov on behalf of clinical team, within global regulatory timelines
Maintains study trackers and ensures they are up to date every week
Educates stakeholders, as needed, on NIH detailed review criteria for registrations as well as on the purpose and format of the different fields in the protocol registration form
Support registration of clinical trials in public registries beyond US/EU as needed

Skills

Clinical Trial Registration

ClinicalTrials.gov

EU PAS

Protocol Management

Stakeholder Liaison

Trial Transparency

Regulatory Compliance

Global Trial Management

Bristol-Myers Squibb

Develops and delivers biopharmaceutical medicines

About Bristol-Myers Squibb

Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, focusing on areas like cancer, autoimmune diseases, and heart conditions. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs, offering affordable alternatives that meet the same quality standards as their branded counterparts. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, enhancing access to healthcare. The company's goal is to improve patient outcomes while maintaining a commitment to sustainability and corporate responsibility.

New York City, New YorkHeadquarters

1887Year Founded

$33,706.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Flexible Work Hours

Hybrid Work Options

Professional Development Budget

Risks

Increased competition in oncology from emerging biotech firms like ArsenalBio.

BMS's lawsuit over the 340B Drug Pricing Program may lead to regulatory challenges.

Rapid AI and digital tech evolution may pose integration challenges for BMS.

Differentiation

BMS focuses on innovative cancer treatments through collaborations like ArsenalBio for T cell therapies.

The company emphasizes digital health technologies, enhancing clinical trial management and patient engagement.

BMS offers both innovative and generic medicines, increasing affordable healthcare solutions.

Upsides

BMS's partnership with Medidata enhances clinical research processes and patient outcomes.

The collaboration with AI Proteins advances novel miniprotein-based therapeutics, expanding therapeutic modalities.

BMS's global license agreement with BioArctic expands its portfolio in neurodegenerative diseases.

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