Clinical Trial Manager / Senior CTM - Oncology (Remote)

Description

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 in the Oncology TA.  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 R/OPU trial team for their responsible R/OPU 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.

Duties & Responsibilities

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 CRO 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 frontloading 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 including adherence to GCP and all global and local regulatory requirements; compliance with SOPs and continuous risk monitoring/mitigation.
• In collaboration with other functions, ensures budget oversight, including support of regular clinical quality monitoring, and safety reporting.
• Monitors progress of patient recruitment endpoints and proactively updates and actions contingencies throughout trial conduct.
• Supports CTL during investigator meetings.
• Establishes and maintains relationships with external experts, investigational sites, Patient Organizations and other stakeholders by coordinating and ensuring cross-functional collaboration amongst CD&O and appropriate functions on regional/ local level.

Trial Closeout and Reporting

• Ensures timely cleaning and delivery of clinical trial data.
• Responsible for timely, complete and compliant archiving of all relevant documents in the TMF, including all required documents from vendors.
• Ensures timely subm