[Remote] Clinical Trial Manager/Senior, Oncology (Remote)

Note: The job is a remote job and is open to candidates in USA. Boehringer Ingelheim is hiring a Clinical Trial Manager/Senior Clinical Trial Manager to lead the operational and scientific oversight, setup, execution, and delivery of assigned late-phase oncology trials at the regional and local level. The role leads the US trial team and oversees trial planning, stakeholder engagement, risk mitigation, conduct, and closeout.

Responsibilities

• 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 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
• 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
• 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 submission of the CTR to Regulatory Authority/Ethics Committee and other external stakeholders as required by local regulations
• Shares information on trial results with Investigational sites and, if applicable, Patients (e.g., lay summaries)

Skills

• Bachelor's degree in life sciences or related field, plus a minimum of six (6) years of experience in clinical research
• Master's degree or PharmD plus a minimum of four (4) years of experience in clinical research
• PharmD degree and completion of a 2-year clinical research fellowship
• PhD or MD plus a minimum of two (2) years of experience in clinical research
• Bachelor's degree in Life Sciences or a related area plus a minimum of ten (10) years' experience in clinical research
• Master's degree or PharmD plus a minimum of eight (8) years' experience in clinical research
• PhD or MD plus a minimum of five (5) years' experience in clinical research
• Experience leading Oncology trials
• Demonstrates skills in complex cross-functional matrix structures of the trial and extended team
• Scientific and Therapeutic Expertise: Demonstrates scientific and therapeutic knowledge and operational expertise across all aspects of clinical trial planning, execution and complexity
• Demonstrates leadership and influential behaviors of supporting, connecting and empowering teams, providing future direction, demonstrating visionary and innovative thinking and inspiring teams to achieve a common goal
• Strategic and visionary thinker who is future focused, creative, courageous and able to navigate through ambiguity
• Ability to integrate study strategy with overall TA portfolio
• Collaborative leader who demonstrates skills and capabilities in setting priorities, managing pace of activities, and efficient usage of resources
• Demonstrates ability to effectively plan, set priorities, and define actions
• Translates complex situations to actionable parts
• Anticipates and resolves challenges and translates learnings to new projects
• Must be legally authorized to work in the United States without restriction

Benefits

• Eligible for a role specific discretionary bonus
• Eligible for relocation
• Medical, dental and vision coverage
• Retirement savings opportunities
• Paid time off
• Paid holidays
• Disability and life insurance benefits
• Other company-sponsored programs

Company Overview