Sr. Manager, TMF System Business Lead at Bristol-Myers Squibb

Hyderabad, Telangana, India

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, BiotechnologyIndustries

Requirements

Bachelor's degree in a related field, such as life sciences, computer science, or business administration
Minimum of 7+ years of experience in clinical development operations, with a focus on eTMF
Preference for experience with project management methodologies and tools
Strong understanding of the primary clinical business systems utilized for TMF process
Excellent teamwork, interpersonal, and communication skills, with the ability to communicate and collaborate with employees and management at all levels and through various formats
Demonstrated ability to work in a matrixed organization with a range of technically, culturally, and geographically diverse teams and to influence areas not under direct control to achieve objectives
Strong analytical and problem-solving skills, with the ability to identify and resolve complex issues
Ability to work independently and manage multiple priorities in a fast-paced environment

Responsibilities

Provide subject matter expertise in the utilization of clinical business systems to promote TMF process and regulatory compliance
Align with process owners to ensure utilization of clinical business systems is conducted in accordance with established processes and procedures
Align with functional stakeholders to represent the end-user needs of TMF to the R&D IT organization including business strategy, business requirements, user testing, and implementation of new systems and enhancements
Collaborate with cross-functional teams, including global development operations, R&D IT, and vendors, to ensure that TMF processes are conducted efficiently and effectively
Provide final business, regulatory, and administrative approvals per applicable SOPs
Actively participate in multiple aspects of User Acceptance Testing including scenario planning, scripting, and coordination with business users
Create and maintain applicable process and workflow documentation, in collaboration with process owners and process leads
Serve as a point of contact for compliance related activities including clinical auditing, inspection readiness, preparedness and support, finding assessments, corrective and preventive action development and delivery, and data integrity and audit trails reviews
Collaborate with R&D IT organization for activities such as active management of super user network, troubleshooting issues across capabilities

Skills

TMF

clinical business systems

regulatory compliance

R&D IT

User Acceptance Testing

SOPs

process documentation

workflow documentation

business requirements

vendor collaboration

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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