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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.
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Position Summary / Objective
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 requirement(s).
Act as one of the points of contact at a Site level for internal and external stakeholders
Position 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/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
- May support Ethics Committee submission, ICF review, collection of documents to/from 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 preparation of Study Initiation Visit materials
- May 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
Degree Requirements
- Bachelors or Master’s degree required
- Field of study within life sciences or equivalent
- Valid driver’s license (as locally required)
Experience Requirements
- At least 5 years of field interim monitoring experience.
Demonstrate leadership skill, 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.
- Recent Phase I field monitoring experience preferred
- Hematology/Oncology strongly preferred
- CART experience preferred
Key Competency Requirements
- 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).
- Microsoft Suite
- Clinical Trial Management Systems (CTMS)
- Electronic Data Capture Systems (eDC)
- Electronic Trial Master File (eTMF)
- Metrics Websites
Travel Required:
- Manages multiple protocols, across therapeutic areas, which require overnight travel, based upon assigned site location and/or geographic territory.
Significant travel outside of region is rare.
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.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles.
Applicants can request an approval of accommodation prior to accepting a job offer.
If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S.
or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com.
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