Senior CRA

Working with Us
Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here uniquely interesting work happens every day in every department. From optimizing a production line to the latest breakthroughs in cell therapy this is work that transforms the lives of patients and the careers of those who do it. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits services and programs that provide our employees with the resources to pursue their goals both at work and in their personal lives. Read more: degree required preferably within life sciences or equivalent
Senior Clinical Research Associate: 5 years of monitoring experience. Demonstrates leadership attributes and capability to take on mentor/coach role. Extensive experience and demonstrated strong performance in all aspects of the role. (Note 5 years of monitoring experience preferred but a combination of monitoring and relevant clinical research experience can be considered).
Act as point of contact for Sites.
Implements the local country and site feasibility process including proposal and validation of country study targets as endorsed by country leadership.
Plans develops and executes timelines and activities for start-up in collaboration with the local study team Global Trial Acceleration Centre (GTAC) and other relevant stakeholders through the review and approval of essential clinical trial and regulatory documents.
Support local regulatory in preparing and performing submissions for Health Authorities including follow up until approval. This includes substantial amendments and any other documentation requiring HA submission.
Manage the end-to-end process for executing Clinical Trial Agreements (CTAgs) with investigator sites.
Prepares contract documents from templates and modify to reflect unique aspects of the particular study including the CTAg financial appendix
Negotiates financial and legal aspects of CTAg and Master Service Agreements with sites Institutions or vendor personnel
Prepare country Informed Consent Form (ICF) and manage country ICF template review and approval of Site ICFs.
Review and approval of Clinical Trial Package (CTP) documentation
Ensures that the electronic Trial Master File (eTMF) contains the relevant Clinical Trial Package (CTP) regulatory documents for site activation and ongoing study management
Update national registries as applicable
Prepare of materials for Site Initiation Visits.
Conduct support Investigator Site Assessment Visits (ISAs) and Site Initiation Visits (SIVs).
Conduct site qualification initiation routine monitoring and close-out visits including post-close out across all trial phases in accordance with the Site Monitoring Plan ensuring adherence to protocol BMS Standard Operating Procedures (SOPs) and ICH GCP
Perform submission to Site Ethics Committees and Site GCP Institution including follow up until approval (protocol amendments/IB and any other documents requiring EC submission). Coordinate the Site Ethics Committees and Site GCP Institution responses with study teams.
Collect and distribute of documents to and from sites including obtaining insurance certificates.
Maintain the ethical and scientific integrity of clinical trials by verifying data within electronic systems and paper records (as applicable) to ensure the accessibility completeness and accuracy of data submitted by study sites.
Monitor site adherence to ICH GCP and local regulations including compliance with the principles of ALCOA to maintain data integrity and reliability. Where required provide training and support to site staff to uphold these standards and ensure patient safety.
Cultivate and sustain effective relationships with internal cross-functional teams and external partners including vendors clinical sites and key stakeholders. Serve as the organizations representative for clinical trials at the site level.
Motivate and influence sites to meet study objectives including enrolment and retention goals.
Communicate effectively adapting to meet the needs of different stakeholders utilizing the most appropriate communication style and method.
Prepare and submit written reports both monitoring and administrative in a timely accurate concise professional and objective manner.
Assess potential Investigators and their sites to ensure sufficient resources and capabilities to conduct clinical trials. May identify new potential Investigators and/or sites through ongoing collaborations with internal and external stakeholders during the site feasibility and selection process.
Demonstrate understanding and proficiency working with targeted centralized remote and risk-based monitoring approaches.
Identify assess and prioritize risks at the site and study level and support sites in mitigating issues including implementing mitigation strategies based on risk indicators.
Utilize strong analytical skills to evaluate site data and operational metrics including ability to adjust monitoring strategies based on data trends and site performance.
Where applicable perform Unblinded Site Monitor activities to protect the blind of the study by acting as secondary monitoring source separate from the blinded monitor.
Accountable for the review reconciliation and oversight of study drug/IMP. May support study drug/IMP label translation needs as applicable.
Involvement in Regulatory Compliance audit/inspection process as needed. This includes the development and implementation of site corrective and preventive actions.
Support provision of access to relevant BMS and vendor systems is available for clinical trial site personnel and ensures internal BMS systems are kept up to date for site monitoring activities
Support coordination of site activities related to database locks to ensure timelines are met as required locally
Perform timely site closure activities when all required protocol visits and follow-up are completed

Senior Level Expectations:
May engage with Clinical Trial Manager and/or line management to assist in the resolution of more complex issues. May also support continuous improvement initiatives and process enhancements as needed
Serve as a subject matter expert in risk-based management tools and methodologies
Serve as a subject matter expert in root cause analysis and CAPA (Corrective and Preventive Actions) processes.
Serve as a key resource for colleagues by providing guidance leading training and mentoring to other team members through a mentoring process using informal and/or formal presentations.
May assist line management with conducting monitoring authorizations and ongoing assessments
May be assigned as a Lead CTMo for a study locally and as determined by RCO Country/Cluster leadership

If you come across a role that intrigues you but doesnt 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 assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles onsite presence is considered an essential job function and is critical to collaboration innovation productivity and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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BMS will consider for employment qualified applicants with arrest and conviction records pursuant to applicable laws in your area.

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