Senior Clinical Trial Monitor

Found in: beBee S IN - 3 weeks ago

Mumbai, India Bristol Myers Squibb Full time
Working with Us
Challenging. Meaningful. Life-changing. Those aren't 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. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. 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: careers.bms.com/working-with-us .

Role Summary:

Responsible for the oversight of the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP). And the applicable regulatory requirements.

Key responsibilities:
  • Act as one of the points of contact at a Site level for internal and external stakeholders.
  • Identifies new potential Investigators, through ongoing collaborations with internal and external stakeholders.
  • Assesses potential Investigators and their sites to ensure they have the resources and capabilities to conduct clinical trials.
  • Develop Site relationships (incl. Contract Research Organization related issue management and non- registrational /Investigator Sponsored Research Studies)
  • Recommends sites during the site feasibility and/or site selection process
  • Conducts pre-study visit as appropriate
  • Conducts initiation visits to ensure Investigator and site personnel receives adequate protocol specific training prior to site activation
  • Reviews site activities and quality through on-site and off-site visits. Conducts monitoring activities and ensures safety and protection of study subjects as per the monitoring plan, BMS procedural documents, protocol, ICH/GCP Guidelines and other local regulations as applicable
  • Perform Unblinded Site Monitor activities to protect the blind of the study by acting as secondary monitoring source separate from the blinded monitor.
  • While monitoring demonstrates the ability to use data to assess risks, identify issues and make appropriate decisions.
  • Serve as a point of contact for Sites
  • Provides trainings to sites
  • Performs site closure activities when all required protocol visits and follow-up are completed
  • Manages multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory.
  • Ensures completeness and quality of data submitted from study sites. Ensures eCRF data is available and current by using the available systems to follow site activities.
  • Oversees activities of site personnel over whom there is no direct authority.
  • Motivates/influences the site to meet study objectives, including enrolment and retention goals. Demonstrates flexibility and adaptability when communicating with different stakeholders utilizing the most appropriate communication method
  • Anticipates, identifies and proactively supports site in resolving issues as they occur. Appropriately documents and promptly escalates serious or persistent outstanding issues to management and project team. Initiates, recommends, documents and communicates corrective actions as needed and follows up to ensure corrective/preventive actions based on root cause analysis are implemented
  • Involvement in Regulatory Compliance audit/inspection process, as needed. This includes the development and implementation of site corrective and preventive actions
  • Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise, professional and objective manner
  • Support Ethics Committee submission, ICF review, collection of documents to/from site
  • Support ensuring access to eDC and BMS / vendor systems is available for clinical trial site personnel
  • Support equipment calibration and tracking
  • Support preparation of Study Initiation Visit materials
  • Support coordination and ensure database lock timelines are met as required locally
Senior Level Expectations:
  • Proactively identify and resolve potential problems at both site and country level.
  • Engage with Clinical Trial Manager and/or line management to assist in the resolution of more complex issues.
  • Proactively seek to enhance communication skills with both internal (Global level) and all relevant external parties and coaches others to do the same.
  • Contribute significantly to study team and coaches site staff to enhance site and hub performance.
  • 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
Degree/Certification/Licensure:
  • Bachelor's degree required preferably within life sciences or equivalent
Experience - Responsibility and minimum number of years
  • Clinical Trial Monitor: 3-4years of relevant clinical research experience, able to work independently.
  • Relevant prior Pharma/Biotech Sponsor employment or experience as a clinical study coordinator preferred
  • Experience in the drug discovery/development process.
Competencies - knowledge, skills, abilities, other
  • Has basic to good knowledge of ICH/GCP Guidelines and applicable local laws and regulations (Health Authorities) which govern clinical trials.
  • Knowledge and understanding of clinical research processes, regulations and methodology
  • Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management
  • Organization and time management skills
  • Ability to build, maintain and strengthen relationships even under pressure and/ or in difficult situations
  • Good verbal and written communication skills (both in English and local language).
Software that must be used independently and without assistance
  • Microsoft Suite
  • Clinical Trial Management Systems (CTMS)
  • Electronic Data Capture Systems (eDC)
  • Electronic Trial Master File (eTMF)
  • Metrics websites
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 an inclusive culture, promoting diversity 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 a diverse 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.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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