Sr. Manager, TMF Process 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
Thorough understanding of ALCOA+ standards, Good Clinical Practice, Good Documentation practices, ICH guidelines, and applicable local regulatory requirements
Strong understanding of the primary clinical business systems utilized for TMF process
Extensive knowledge of clinical trial documentation and TMF Management activities
Strong technical understanding of Vault eTMF system
Strong working knowledge of TMF and technical knowledge of Vault eTMF and clinical document management

Responsibilities

Provides leadership within the TMF governance structure, acting as Subject Matter Expert for process groups and within cross-functional teams
Supports process optimization, continuous improvement, and quality governance for active studies
Represents TMF Process and eTMF Operations at meetings and leadership panels
Develops training materials, templates, job aids, plans, etc., for TMF and archival processes
Provides training, support, and coaching for eTMF Operations Analysts, TMF Study Leads, Archive Leads, and Specialists (including CRO/FSP teams), on TMF processes and operating models
Develops, updates, and maintains Procedural Documents, SOPs, Work Instructions, etc., for TMF and archival processes and operations
Oversees compliance activities for TMF and archiving, including Patient Data Report generation, distribution, and CRO TMF transfers
Implements technical enhancements to eTMF, including innovation and automation, for improved quality and compliance oversight
Communicates and coordinates with internal and external stakeholders to ensure TMF compliance and inspection readiness
Leads and manages strategic collaboration between BMS and CROs to ensure adherence to TMF processes and regulatory compliance, serving as the primary liaison for all TMF compliance matters
Collaborates and consults multifunctionally to promote and support business and regulatory compliance and to identify opportunities to increase process and control efficiency
Provides technical leadership for eTMF operations and archival systems (e.g., Vault Clinical/Veeva CTMS/eTMF)
Identifies and addresses technical gaps in TMF systems
Develops and monitors KPIs and metrics for TMF and archival compliance
Leads and participates in continuous improvement initiatives related to TMF management, archival, and compliance
Addresses process compliance and performance gaps, as highlighted by quality metrics and KPIs
Leads and participates in TMF audits and inspection activities (readiness, preparedness, and management)

Skills

TMF

eTMF

SOP

Process Optimization

Governance

Training Development

Compliance

Archival Processes

CRO Management

Automation

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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