Job Description

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 Clinical Site Manager is responsible for phase I-IIIB clinical trial execution and oversight at the country and site level. Provides leadership and planning to ensure the effective and efficient delivery of the operational aspects of sites on assigned protocols. The Clinical Site Manager has significant impact on delivering US specific study commitments and objectives while ensuring adherence to quality and timelines.

Independently monitors the progress of assigned Investigative sites by maintaining close contact with site personnel and Site Monitors. Coordinates and maintains effective communication (oral, written), and serves as primary BMS contact for sites. Provides feedback and status updates to internal stakeholders. Independently manages activities at the site by providing guidance as required and by collaborating with other key stakeholders. Documents substantive contacts concisely and in accordance with SOPs. Identifies potential site issue and suggests resolutions. Demonstrates understanding of data management activities and ensures data currency for assigned sites. Demonstrates a thorough understanding of all steps in the clinical research process.

Purpose/Objective

* Project Manager of US site management deliverables.
* Independently monitors conduct of clinical trials and management of US investigative sites from study start-up through database lock and study closure.

Key Responsibilities and Major Duties

* US Site Management Oversight Supports Lead Site Manager in the Site Selection process, effectively using analytics, advocacy, clinical trial partnership sites and feedback from key stakeholders on the clinical team.
* Contributes to completion of country profiler (setting US targets), sets country level Site Activation Plan targets, and contributes to Site Communication Plans to manage the recruitment process for assigned sites.
* Provides input into country level patient recruitment plans.
* Utilizes reports to monitor timely site activation, and compares planned versus actual enrollment/randomization to identify and reduce the % of low enrolling sites on the study.
* Uses additional metrics as applicable, and follows up with sites to ensure all US targets are met.
* Serves as first point of contact for all assigned study sites.
* Maintains effective communication and builds collaborative relationships with sites.
* Participates in study start up activities, including regulatory document preparation collection and review; trains sites/internal staff in BMS protocols and processes; co-facilitates Site Initiation Visits with the Site Monitor.
* Provides oversight and quality checks to ICFs, responsible for ensuring necessary account access to BMS using the RABs system for site staff, and ensures mandatory entries are made in ECLIPSE.
* Accountable for facilitating, tracking and monitoring progress of study site activities; communicating and documenting issues including risks, mitigation plans and any issue resolutions using the RCO Study Management Planner.
* Facilitates data collection, tracking, clinical data review and cleaning per protocol level Data Review Plan using study management systems to maintain data quality.
* Competent in using new technologies such as ePRO, MyTrials etc. in managing studies and relationships with the sites.
* Proactively monitors and reconciles safety data (i.e. Serious and non serious adverse events).
* Appropriately escalates safety trends. Liaises with vendors, i.e., Central Labs, Central Institutional Review Boards and/or CROs including vendor set up and issue resolution.
* Coaches and mentors Interns and Clinical Site Managers new to BMS or those with less expertise within a TA or a process, and provides subject matter expertise within department.
* Represents RCO Site Management interests on cross-functional process improvement initiatives.
* Improves processes and supports process changes within and beyond the RCO STM department.
* Leads or contributes to initiatives, task forces and/or SME teams at RCO-US level.
* Participates in activities including adjudication, narrative review, advisory board committee and FDA filing related activities, if needed.
* Ensures quality study conduction and prepares the CAPA for site/internal audits.
* Assists the project team in preparation for audits/inspections and is responsible for quality and completeness of in house documentation employing the principles of ready every day.
* Contributes to the establishment of best practices and Lessons Learned.
* Proactively identifies potential quality risks and takes corrective actions as necessary.
* Project Management Independently disseminates information to appropriate BMS team members to ensure country level site management activities, protocol execution and study documentation are in compliance with study timelines, ICH-GCP guidelines, BMS SOPs and local regulatory guidelines or regulations.
* Proactively provides feedback and status updates to internal stakeholders.
* Competent in identifying risks and crafting mitigation strategies that affect timelines and quality.
* Addresses/Escalates/Documents potential issues at the site or protocol level and suggests solutions.
* Independently manages study sites to ensure compliance with ICH/GCP guidelines and study deliverables, from study start up through database lock and site close out.

Minimum Requirements:

* Degree/Certification/Licensure - Bachelor's degree in Nursing, Life Sciences, Pharmacy or Allied Health
* Experience /Responsibility and minimum number of years - Minimum of 3-7 years experience in clinical research (conduct and manage of Investigator site, site monitoring or site coordinator role from study start up through database lock and study close out).
* BioPharmaceutical industry and in-house site management experience preferred.
* Experience in effective planning and implementation of clinical trials and document preparation.
* Experience working in a matrix environment. Works well across organizational, functional and geographic boundaries to achieve company goals.

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.

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 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.