Senior Clinical Trial Monitor
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
The Sr. Clinical Trial Monitor is responsible for oversight the progress of a clinical trial and ensuring that it is conducted, recorded, and reported under the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).
Act as one of the points of contact at a Site level for internal and external stakeholders
Ideal candidates will be located in Philadelphia,PA
Key Responsibilities and Major Duties
- 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 site selection process
- Conducts pre-study visits as appropriate
- Conducts initiation visits to ensure Investigator and site personnel receive adequate protocol-specific training before site activation
- Reviews site activities and quality through on-site and off-site visits. Conducts monitoring activities and ensures the 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 training to sites
- Performs site closure activities when all required protocol visits and follow-ups are completed
- Manages multiple protocols across therapeutic areas, which may require travel based on assigned site location and 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 the site in resolving issues as they occur. Appropriately documents and promptly escalates severe or outstanding persistent problems to management and the project team. Initiates, recommends, records, communicates corrective actions as needed, and follows up to ensure corrective/preventive measures 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
- May support Ethics Committee submission, ICF review, and collection of documents to/from the site.
- May support ensuring access to EDC and BMS / vendor systems is available for clinical trial site personnel.
- May support equipment calibration and tracking.
- May support the preparation of Study Initiation Visit materials.
- May support coordination and ensure database lock timelines are met as required locally.
- Proactively identify and resolve potential problems at both site and country levels.
- Engage with Clinical Trial Manager or line management to assist in the resolution of more complex issues.
- Proactively seek to enhance communication skills with internal (Global level) and all relevant external parties and coach others to do the same.
- Contribute significantly to the study team and coaches site staff to enhance the site and hub performance.
- Serve as a critical resource for colleagues by providing guidance, leading training, and mentoring other team members through a mentoring process using informal 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.
- Bachelor's degree required, preferably within life sciences or equivalent.
- Valid driver's license (as locally required)
- At least five years of monitoring experience.
- Demonstrate leadership skills, mentor and coach capability
- Relevant prior Pharma/Biotech Sponsor employment or experience as a clinical study coordinator preferred
- Experience in the drug discovery/development process.
- 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 or in difficult situations
- Good verbal and written communication skills (both in English and local language).
- Microsoft Suite
- Clinical Trial Management Systems (CTMS)
- Electronic Data Capture Systems (EDC)
- Electronic Trial Master File (eTMF)
- Metrics Websites
- Travel varies according to the book of work and region's needs. Travel in an outside of the region typically 20-30%; may include air and overnight; hCELG studies may require up to 65%
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
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