Senior Clinical Trial Manager
Abata TherapeuticsSalary not specified
Full Time
Senior (5 to 8 years)
Sr. Manager, Clinical Trial Risk Analyst at Bristol-Myers Squibb
Hyderabad, Telangana, India
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Biotechnology, Clinical TrialsIndustries
Requirements
- Expertise in clinical trial risk management within a Risk Based Management (RBM) framework
- Ability to conduct remote assessment of risk and data quality analytics using statistical methodologies to identify trends, outliers, and unusual patterns in clinical and operational data
- Experience in study-level risk analysis, reporting, and oversight of sites/countries/studies for compliance, patient safety, data quality, and reliability
- Skills in evaluating, monitoring, escalating, and reporting risks with potential broad, significant, or systemic impact on quality, compliance, and operational deliverables
- Leadership and management experience overseeing teams of risk monitoring professionals
- Capability to manage workloads, assign resources, forecast resource needs, and ensure timely delivery
Responsibilities
- Oversees a team of risk monitoring professionals in planning, coordination, and timely delivery of information to support risk evaluation and mitigation, internal decision making, regulatory approval, and market acceptance
- Empowers and holds staff to high quality performance and delivery of the business
- Manages the book of work, assigning resources to studies and initiatives, monitoring workloads to avoid delays, and forecasting future resource needs
- Provides effective coaching and mentoring to risk monitoring professionals to ensure high levels of performance and productivity
- Offers ongoing feedback, coaching, and career development, including engagement and retention support to maximize staff potential
- Develops and promotes a workplace culture that values diversity of thought, promotes integrity, supports coaching, and fosters accountability
- Leads or contributes to Protocol De-risking process, supporting identification of critical to success factors and critical to quality factors, including critical data and processes
- Collaborates with the Data Management Lead (DML), Clinical Trial Risk Lead (CTRL), R&D Quality, and applicable GDO & TA functions
- Works conjunctly with peers to ensure consistency in risk oversight across the clinical trial portfolio
Skills
Risk Based Management
RBM
Clinical Trial Risk Management
Data Quality Analytics
Statistical Methods
Risk Assessment
Clinical Data Review
Operational Data Analysis
Trend Analysis
Outlier Detection
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