Senior Clinical Site Monitor

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.


Position is based in the Atlanta, GA area and will require on site visits (overnight travel may occur at approximately 20%).

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.

Internal Stakeholders include -

Medical Monitor (MM), Protocol Manager (PTM), Clinical Trial Leads, Clinical Trial Associates (CTA), Site Relationship Managers, Study Start-up Specialists, Site Contract Leads, Vendor Operations Managers, Regional Clinical Compliance Leads, Central Data Reviewer (CDR), Data Management Leads, Line Managers(LM), Head, Clinical Operations , local Regulatory and local Medical Affairs team

External Stakeholders include -

Principal Investigator, Sub-Investigators, Study Coordinators, Research Nurses, Research Managers, Data Managers, Pharmacists, Ethics Committees , Vendors, MOH Personnel (where applicable), GCP Office (China only)


Minimum Qualifications


Senior Clinical Trial Monitor: At least 5 years of monitoring experience. Demonstrate leadership skill, mentor and coach capability

Relevant prior Pharma/Biotech Sponsor employment or experience as a clinical study coordinator preferred

Bachelors or Master’s degree required

Field of study within life sciences or equivalent

Valid driver’s license (as locally required)

Experience in the drug discovery/development process.


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/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


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 the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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