Manager, Clinical Trial Risk Analyst

Bristol Myers Squibb

3 - 6 years

9 - 13 Lacs

hyderabad

Posted:3 weeks ago| Platform:

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Skills Required

data analysis operations gcp compliance auditing root cause analysis communication skills risk analysis

Work Mode

Work from Office

Job Type

Full Time

Job Description

Oversees a team of risk monitoring professionals in planning, coordination, and timely delivery of information to support risk evaluation and mitigation.
Empowers and holds staff to high-quality performance and delivery of the business.
Manages the book of work, assigns resources to studies and initiatives, and monitors workloads to avoid delays.
Forecast future resource needs based on the book of work and develops specifications to set up KRIs, Data Quality Assessments (DQA), and QTLs.
Collaborates with the Data Management Lead (DML), Statistician, Global Trial Lead (GTL), Quality Lead, Clinical Trial Physician, Clinical Scientist, and other study team members to put together an initial proposal on KRIs and QTLs.
Leads or contributes to the Protocol De-risking process, supporting the identification of critical to success factors, critical to quality factors including critical data, and critical processes.
Partners with the DML and other data review functions to determine the holistic data review strategy for the study and documents the Risk Monitoring data analysis responsibilities in the applicable functional plan.
Provides regular risk monitoring at the study level for priority studies and ensures appropriate escalations of emerging risks (including QTL deviations) to the CTRL.
Triages new and previously open signals in preparation for the Risk Review Meetings (RRM) to prioritize the signals for discussion and prepares a list of recommended actions.
Relates insights from the CM analysis back to the original risk discussions to share a compelling 'risk story' and drives ongoing risk discussions within the study team throughout the lifecycle of the trial.
Contributes to the development and maintenance of metrics that inform the evaluation of risk monitoring performance and effectiveness and supports strategic direction of Risk Based Management within the business.
Ensures effective quality oversight and management of external partners performing Risk Management or Risk Monitoring activities on behalf of BMS.
Coaches, mentors, and develops new team members and takes on additional responsibilities as directed by leadership.
Reports relationship: This role will report to a member of the Clinical Trial Risk Management Leadership Team within the TRIM organization.

Job Requirements

A minimum of 5 years of experience in clinical trial operations and/or Good Clinical Practice is required.
Demonstrated expertise in Risk-Based Monitoring principles and relevant tools is essential.
Technical expert in data analysis and interpretation using data visualizations to derive meaningful insights.
Advanced Leadership skills with the ability to influence and manage key internal stakeholders.
Excellent communication, collaboration, and teamwork skills are necessary.
Ability to create a compelling story based on data insights that is meaningful to the target audience.
In-depth understanding of GCP, compliance, and regulatory expectations.
Experience in people leadership.
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.. Uniquely Interesting Work, Life-changing Careers. With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion, and integrity bring out the highest potential of each of our colleagues..
On-site Protocol: BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based, and remote-by-design jobs. The occupancy type that you are

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