Sr. Clinical Trial Manager

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. CTM's General Position Responsibilities Coordinates country cross functional teams and acts as the main point of contact for a Country with the Global Trial 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 Investigator Assessment Visits (ISAs) 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. Senior Level Expectations : Engage with Global Trial Manager, line management and/or Head of Clinical Operations to assist in the resolution of complex issues both locally and/or globally 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 Early Clinical Development CTM Specific Competency (EG 120) ; 1) Knowledge of Early Clinical Development Landscape (Modelling level) Knowledge of in country opportunities & strengths, alignment of studies to these Sharing knowledge & building a repository of this knowledge Competitive Intelligence gathering, sorting and applying 2) Early Clinical Trial Execution (Modelling level) Understanding local regulations, requirements for ECD trials Executes on CTM role & responsibilities High quality compliance execution to trials Ability to be flexible with working hours owing to high touch points with central study teams 3) Business Acumen/Enterprise Mindset (Advancing level) Having a clear understanding of the business strategy (big picture) and able to clearly articulate this Understanding of local market business and how ECD fits into this Developing networks into other RCO Pacific countries where lessons learned and frameworks could be applied Presenting to RCO Pacific LT and interacting with other leaders in business 4) Stakeholder Management (ECD Clinical Trial Sites & Internal team members) (Advancing level) Ability to influence at all levels (global study team, inter-department, external with sites) Ability to connect appropriate stakeholders to solve a problem, how to get the right people in the room Sharing information 5) Leadership & Change Management (Advancing level) Ability to make decisions and appropriate escalation Ability to breakdown complex problems, demonstrate how its applicable to stakeholders and advance actions to resolve Strong people developer (e.g. development opportunities for team members) Ability to assess and prioritise issues and activities in a dynamic environment Global cross cultural leadership & mindset 6) Learning Agility & Communication (Advancing level) Upskill across a number of disease areas; understand evolving data & internal strategy Ability to communicate in open and transparent manner with multiple stakeholders; ability to translate complexity into clear and relevant messages for stakeholders 7) All competencies_Behavior Accountability to deliver Collaboration Change agility Integrity Proactively addresses concerns in a constructive manner Understanding relevant different viewpoints Win/win and positive mindset Involves appropriate stakeholders to facilitate resolution Actively shares information, experiences and perspectives in meetings in a transparent and honest way Ability to present ideas/initiatives to a wide and diverse audience Identifies stakeholders and understands how to engage them Practice effective consensus building and influence without authority Ability to impact and influence others to take action and contribute towards the establishment of best practices 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.