Clinical Trial Manager/Senior, 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 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.

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 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.

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 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).

Requirements

Clinical Trial Manager Education/Experience Requirements:

• Bachelor's degree in life sciences or related field, plus a minimum of six (6) years of experience in clinical research.
• OR
• Master's degree or PharmD plus a minimum of four (4) years of experience in clinical research.
• OR
• PharmD degree and completion of a 2-year clinical research fellowship.
• OR
• PhD or MD plus a minimum of two (2) years of experience in clinical research.

 Senior Clinical Trial Manager Education/Experience Requirements:

• 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.
• OR
• PhD or MD plus a minimum of five (5) years’ experience in clinical research.

Role Requirements

• Experience leading Oncology trials.
• Demonstrates skills in complex cross-functional matrix structures of the trial and extended team.
• Scientific and Operational 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.
• Ability and willingness to travel domestically and internationally (10-20% of time).

Eligibility Requirements

• Must be legally authorized to work in the United States without restriction.
• Must be willing to take a drug test and post-offer physical (if required).
• Must be 18 years of age or older.

Compensation

The base salary range for the Clinical Trial Manager position is $128,000 to $192,000 and the base salary range for the Senior Clinical Trial Manager is $165,600 to $248,400. The position may be eligible for a role specific discretionary bonus, relocation, and/or other compensation elements. We continuously review market data and may adjust salary ranges as needed in the future. Actual compensation will be based on job-related factors such as skills, experience, and qualifications, and other factors permitted by law.

Benefits include medical, dental and vision coverage, retirement savings opportunities, paid time off, paid holidays, disability and life insurance benefits, and other company-sponsored programs.

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