This Senior Site Monitoring position is similar to a Senior Clinical Research Associate role (please read the job description below for more information). We are looking for someone in the Boston, MA area to travel mostly in the local area with the possibility to travel regionally (approx. regional travel up to 20%) if necessary.
• Serve as the site facing role for clinical operations at sites within a region.
• Expedites the pre-study and study initiation processes including conduct of Pre-Study Evaluation and Site Initiation Visits in collaboration with Site Managers and/or Protocol Managers, where applicable, to orient and train site personnel regarding the protocol and applicable regulatory requirements.
• Identified, evaluates and recommends potential investigators/sites on an on-going basis within assigned region.
• Critically reviews and analyzes site activities through targeted risk based site contacts and on-site visits to monitor study sites protocol execution and compliance to applicable BMS SOPS, subject protection and ICH and/or FDA GCP Guidelines and other local regulations. This includes but is not limited to: Managed multiple protocols, across therapeutic areas, which may require travel, based upon assigned site location and or/geographic territory. Significant travel outside of region is rare.
• Ensures timely entry and quality of data submitted from study sites.
• Supervises overall activities of site personnel over whom there is no direct authority and motivates and influences site personnel to meet study and timeline objectives.
• Anticipates and proactively resolves study site issues as they occur. This includes the ability to conduct root cause analysis, implementing corrective actions, ensuring appropriate preventative actions are developed, implemented and being followed and finally the ability to demonstrate via verbal and written methods the process or “story” of the issue.
• Ensures documented follow-up to all outstanding issues within monitoring management system ensuring appropriate issue escalation to line manager and project team members as necessary.
• Facilitates, as needed, internal regulatory compliance audits and Health Authority inspections for assigned sites.
• Provides monitoring assistance to site monitor colleagues within and outside of region to ensure timely execution of deliverables.
• As a Sr. Site Monitor, serves as the example of professionalism, collaboration and efficient execution of deliverables, including mentoring others.
• Proactively communicates and escalates with all internal and external stakeholders any significant issues identified at study sites while developing corresponding mitigation strategies and solutions.
• Prepares and submits monitoring and management reports in a timely, accurate, concise and objective manner.
• Initiates, develops and grows professional and collaborative relationships with Principal Investigators, all study personnel and necessary institution stakeholders.
Ability to drive a company-provided car is an essential qualification of this position. Candidates must be able to drive a BMS-provided vehicle between locations (often a great distances apart), and arrive at each location ready and able to enthusiastically and efficiently demonstrate an applied knowledge of pertinent health care industry trends. Candidates must possess a high level of ethics, integrity and responsible and safe driving history.
• 10+ years of pharmaceutical development experience with at least 5 years of advanced site monitoring/management in complex small molecule and biologic trials in a wide array of diseases (oncology, transplant, HIV, etc.) across the development spectrum (phases I-IV).
• At minimum a Bachelor of Arts or Science, or equivalent, in health related field from an accredited institution.
• Extensive knowledge of ICH/FDA guidelines and thorough knowledge of global Health Authority (e.g., EMA, MHRA) regulations impacting activities in the US.
• Thorough technical working knowledge of Remote Data Capture, EMR and computer based systems.
• Thorough knowledge, experience preferred, of industry trends (Risk Based Monitoring, Remote Monitoring, Remote Source Data Verification/Review, etc.)
• Ability to resolve a majority of complex study/site related issues independently using functional expertise while exercising excellent judgment and decision making skills.
• Exhibits a high level of flexibility and sets an example for adaptability for changing priorities and processes.
• Employs strong fiscal management of departmental budget by independently managing travel and functional expenses.
• Identifies innovative solutions to accomplish objectives while maximizing utilization of budget, resources and time.
• Demonstrates strong project management skills when engaging with stakeholders to ensure efficient management of timelines, resources, encountered challenges and stakeholders.
• Serves a role model for department through active planning, participation and representation on various projects, initiatives involving a wide breadth of internal and external stakeholders.
• Ability to successfully manage the designated book of work, adjust accordingly for risk based monitoring practices using critical thinking skills, and prioritize actionable items as necessary
As this position requires operation of a Company-provided vehicle, offers of employment are contingent upon the candidate meeting the requirements of “Qualified Driver,” as determined by the Company in its sole discretion, including but not limited to the following: 1) at least 21 years of age; 2) a driver’s license in good standing issued by your state of residence; and, 3) a driving risk level deemed acceptable by the Company.
At least 10 year(s)
Posted / Updated: