Senior Clinical Trial Manager
Abata TherapeuticsSalary not specified
Full Time
Senior (5 to 8 years)
Not SpecifiedCompensation
Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, BiotechnologyIndustries
Requirements
- BA/BS degree, science/technology field preferred
- 1-2 years pharmaceutical experience
- Proficient knowledge of Regulatory Submissions and package content for non-US clinical trial applications to health authorities
- Proficient use of CTMS, Tracking systems, Excel trackers to generate reports and track CTA content and associated dates
- Communicates questions and issues as they arise
Responsibilities
- Manage the signing of clinical trial documentation such as powers of attorney, coordinating many signings at the same time
- Provide support to the Submission Senior Specialist/Manager in CTA preparation activities for initial filings and start-up activities, protocol amendments, end of trials, and CSR distributions
- Prepare and distribute the global Clinical Trial Application dossier and subsequent substantial amendments to country applicants and CROs for submission to ECs and HAs
- Prepare the data required in CTIS for global Clinical Trial Application dossiers and their subsequent substantial modifications
- Ensure consistency of the Clinical Trial application across projects, studies, and countries
- Actively participate in Program/Study level CTA Tracking Meetings, led by Senior Specialist/Manager, in preparation of the CTA dossier, ensuring timelines and dossier quality are managed according to expectations
- Liaise with country offices and central team (Clinical Supply Operations, Operation Leads, Protocol Managers, Medical Monitor, Safety, Quality Person) to ensure Clinical Trial application activities are in compliance with study timelines, BMS SOPs, worldwide regulatory guidelines, and regulations
- Comply with the use and maintenance of planning & tracking tools (e.g., Veeva - HA submission and approval Tracking system) to generate reports and track CTA content and associated dates
- Escalate to study teams and GSM-CT senior roles observed trends and issues that may impact timely and successful study approval and execution
- Contribute to the Global Country Requirements Repository by collecting and sharing additional country requirements
- Support initiatives for innovation and simplification in processes to improve support to study teams and GSM-CT
- Coordinate updates within a Program
- Support continuous improvement and compliance initiatives
- Utilize technology effectively to support the clinical trial application submission process
- Contribute to other requirements as appropriate to allow proper functioning of the GSM-CT
- Support implementation of the EU CT REG Portal from Feb 2022
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What benefits does Bristol Myers Squibb offer?
Bristol Myers Squibb offers a wide variety of competitive benefits, services, and programs that provide employees with resources to pursue their goals both at work and in their personal lives.
Is this position remote or does it require office work?
This information is not specified in the job description.
What are the main responsibilities of the Submission Specialist?
The role involves managing the signing of CTA documentation, preparing and distributing global Clinical Trial Application dossiers and amendments, preparing data for CTIS, ensuring consistency across projects, and liaising with country offices and central teams for compliance.
What is the company culture like at Bristol Myers Squibb?
The culture is challenging, meaningful, and life-changing, with uniquely interesting work, opportunities to grow alongside high-achieving teams, and emphasis on balance and flexibility in the work environment.
What makes a strong candidate for this Submission Specialist role?
Strong candidates should have experience managing clinical trial documentation signings, coordinating with multiple teams, ensuring regulatory compliance, and using tracking tools like Veeva, with the ability to handle multiple tasks simultaneously and meet timelines.
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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