Clinical Trial Manager​/Senior, Oncology; Remote

The Clinical Trial Manager (CTM) /Senior CTM is accountable for the operational and scientific oversight, the set-up, execution and delivery of their assigned clinical trials at the regional/local level. This specific CTM role will be working on Oncology studies specifically in late phase. CTMs contribute to delivery of Boehringer Ingelheim’s pipeline through accurate planning and efficient execution of trials that bring speed & value to participating patients and sites.

The CTM provides leadership and direction to the local US trial team and is accountable for the overall success and delivery of their assigned clinical trial/s according to defined milestones and key performance indicators. They are responsible for steering and directing clinical trial activities, including patient and site engagement activities, direct communication and interaction with multiple internal and external stakeholders (e.g., investigative sites) and trial team members at a regional/local and global level.

The CTM is responsible for managing the planning, implementation, and tracking of the clinical trial process as well as risk mitigation. The CTM serves as a proactive member of the trial team, liaising closely with the Clinical Trial Leader (“CTL”) on all study-related issues. As leader of the US Trial Team, the CTM communicates trial status to stakeholders, escalating issues as appropriate.

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance.

Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Trial Preparation

• Ensures the trial is conducted in compliance with GCP-ICH, local/global regulations, applicable SOPs and according to the trial protocol by overseeing vendor and internal team activities.
• Creates, manages and reviews trial budget and updates to ensure appropriate level of financial oversight and planning accuracy.
• Responsible for appropriate trial-specific training of internal and external partners is performed in line with Trial Training Plan.
• Responsible for accurate planning and co-ordination of operational feasibility of trial timelines.
• Verifies and provides input into the country and site level feasibility and commitment (site and patient commitment).
• Finalizes and validates site selection using available data sources and local insights/expertise, in collaboration with cross-functional departments.
• Responsible for development and implementation of country level engagement plans, recruitment planning and risk mitigation.
• Co-ordinates development of country level patient facing documents in close collaboration with relevant internal and external stakeholders.
• Reports patient and site level feedback as strategic insight to contribute to improving trial design with a focus on patient value.
• Responsible for front loading of activities to facilitate efficiencies as well as to ensure and leverage speed.
  Oversees outsourcing of vendor services in accordance to operating models and governance.
• Ensures timely responses to questions from Regulatory Authority/Ethics Committee and other external stakeholders.

Trial Conduct

• Maintains oversight during clinical trial conduct…