[Remote] Senior Manager, Clinical Program Management (Clinical Operations) at Bristol-Myers Squibb

United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

Requirements

Minimum 5-7 years clinical operations experience within biotech, pharma or CRO industry
BA/BS degree, scientific or healthcare discipline preferred
Independent professional who proactively communicates frequently and effectively
Detail and action-oriented, organized and committed to quality and consistency
Ability to work successfully in cross-functional teams
Ability to work in a dynamic environment with a high degree of flexibility
Expertise in Microsoft Project and Smartsheets desired
Up to 20% travel required

Responsibilities

Manage global clinical study teams, CROs and vendors to ensure that the study(ies) are completed on time, within budget, and in compliance with RayzeBio SOPs, FDA regulations and ICH/GCP guidelines
Lead the cross-functional study execution team in achieving the study goals and deliverables
Plan and execute study timelines
Develop and manage risk mitigation strategies for clinical studies
Track, monitor and report on study progress and proactively escalate issues to key internal stakeholders to ensure timely resolution of issues
Manage study CRO and vendor budgets and invoicing procedures according to study contract
Perform oversight review and quality control of CRO and vendor scope of activities, ensuring compliance to key performance metrics and overall inspection readiness
Active participant in CRO and vendor meetings, responsible to review key CRO and vendor study operational plans and provide input to operational strategy, including country and site feasibility and start-up
Summarize CRO and vendor performance data and escalate study risks to the Head of Clinical Operations
Perform other related duties as assigned

Skills

Key technologies and capabilities for this role

Clinical Program ManagementCRO ManagementVendor ManagementGCPICH GuidelinesFDA RegulationsSOPsStudy Timeline ManagementBudget ManagementCross-Functional Team Leadership

Questions & Answers

Common questions about this position

What education and experience are required for this role?

A minimum of 5-7 years of clinical operations experience within biotech, pharma, or CRO industry is required, along with a BA/BS degree in a scientific or healthcare discipline preferred.

Is travel required for this position?

Up to 20% travel is required for this role.

What is the salary or compensation for this position?

This information is not specified in the job description.

What is the company culture like at Bristol Myers Squibb?

The culture is described as challenging, meaningful, and life-changing, with uniquely interesting work, opportunities to grow and thrive alongside high-achieving teams, and a focus on balance and flexibility.

What skills make a strong candidate for this role?

Strong candidates will have experience managing global clinical study teams, CROs, and vendors, developing study timelines and risk mitigation strategies, and ensuring compliance with SOPs, FDA regulations, and ICH/GCP guidelines.

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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