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.

Summary

Project manager for US Clinical Trial Management deliverables. Accountable for clinical trial execution and oversight at the country and site level. Engage with start-up teams in site selection and study start-up activities, monitor the conduct of trials and manage the trial from study start through database lock/study closure, according to SOPs, GCP and regulatory guidelines. Coordinates and maintains effective communication with internal and external stakeholders and serves as the primary BMS contact for the site. Provide leadership and planning support to ensure delivery of the operational aspects of sites on assigned protocols with overall accountability for resourcing, deliverables and productivity. Responsible for eTMF completion, coordination and development of CAPA, implementation of country audit level findings, coordination of database locks, resolution of discrepancies, preparation of country specific documents, and inspections readiness for assigned trials. Demonstrates full understanding of data management activities and monitor data quality. Skilled in the use of technology. Demonstrates a thorough understanding of all steps in the clinical research process.

Key Responsibilities and Major Duties:

* Coordinates country cross functional teams and acts as the main point of contact for a Country with the protocol manager and other global study team members
* Coordinates with other internal roles in country and site feasibility process, including proposal and validation of country study targets
* Develops country level patient recruitment strategy & risk mitigation. Coordinates and ensures country level study enrolment targets and timelines are met
* Leads problem solving and resolution efforts including management of risk, contingencies, issue resolution and escalation to the appropriate stakeholder/s
* Assessment and set up the of vendors during study start up period (locally)
* Investigator Meeting participation and preparation
* Ensures data entered in Clinical Trial Managements Systems is current and complete and access to eDC and vendor systems is available for the Country and clinical trial site personnel
* Validation of study related materials (i.e. protocol, ICF, patient material)
* Responsible for preparing country specific documents (e.g. global country specific amendment)
* Prepares materials for Site Initiation Visits
* Responsible for verifying and confirming with local team eTMF completeness (Country and Site level)
* Reviews Site Monitoring visit reports, takes action within the timelines specified and escalates issues and ensures appropriate documentation of issues.
* Coordination of database locks and query follow up. Ensures timelines are met.
* Ensure inspection readiness of assigned trials within country. Provide support to Health Authority inspection and pre-inspection activities
* Coordinates, develops and writes the Corrective Actions / Preventive Actions (CAPA) and ensures implementation for Country audit level findings. Drives CAPA review, implementation and completion.
* Lead study team meetings locally
* Reviewing and approving payments (based on GOA) and manage patient compensation claims (if applicable)
* Management of Site relationships (includes CRO related issues)
* May conduct Pre-Study Evaluation Visits (PSEVs) and Site Initiation Visits (SIVs)
* May perform site closure activities, including post-close out
* May act as point of contact for Sites
* May support preparing submissions to and obtaining approval from local Health Authorities, Ethics Committees and other relevant instances.

Requirements:

* Bachelors or Masters degree required. Field of study within life sciences or equivalent.
* Minimum of 4 years' industry related experience
* Thorough understanding of GCP, ICH Guidelines and Country regulatory environment
* In depth 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
* Demonstrated organizational and planning skills and independent decision- making ability
* Strong organization and time management skills and ability to effectively manage multiple competing priorities
* Ability of critical thinking and risk analysis.
* Strong communication skills with a strong customer focus, able to manage both internal and external clients at all organizational levels
* Skilled in the use of technology
* 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)

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.