Clinical Trial Manager / Senior - On-site

Description

Boehringer Ingelheim is currently looking to hire and pipeline for qualified and experienced Clinical Trial Managers (CTMs) across many different Therapeutic Areas (TAs). Experience in various TAs will be considered; however, we do have some CTM openings specific to the TA of Oncology in which we will be seeking candidates that have extensive Oncology experience. This is a Hybrid position, requiring the individual to work on-site at our Ridgefield, CT office 2-3 days per week. Preference will be given to candidates who are either local or can commute to our Ridgefield, CT office or who are willing to relocate.

The Clinical Trial Manager (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. CTMs contribute to delivery of BI’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 (e.g., Medicine Excellence KPIs -MedEx). 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 R/OPU 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, diversity and inclusion, 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 - Accountable for the trial activities for responsible R/OPU, including but not limited to:

• 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 the R/OPU trial budget to ensure appropriate level of financial oversight and planning accuracy
• Responsible for timely budget updates based on trial changes
• Responsible for appropriate trial-specific training of R/OPU 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 for their R/OPU; and oversight of trial preparation to ensure trial team members are aligned and on track
• Verifies and provides input into the country and site level feasibility and OPU commitment (site and patient commitment)
• Finalizes and validates site selection using available data sources and local insights/expertise, in collaboration with other functions (i.e., Medical Affairs, Field Based Medicine (FBM), vendors if applicable)
• 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 where possible at the R/OPU level to facilitate efficiencies as well as to ensure and leverage speed.
• Oversees outsourcing of vendor services in the R/OPU 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 (i.e., Medical Affairs, FBM, Market Access, PAR) on regional/ local level
• Actively participates in the CD&O community with a special focus on participating in the CTM network, to actively contribute to functional excellence.
  
  
  

Duties And Responsibilities Continued

Trial Closeout and Reporting

• Ensures timely cleaning and delivery of clinical trial data
• Responsible for timely, complete and compliant archiving of all relevant R/OPU 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)
  
  
  

General Accountabilities

• Builds and maintains engagement with Investigators, other site staff and Patient Organizations (POs), in collaboration with other functions, to ensure trial speed and effective start up, conduct and close out
• 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 (i.e., Medical Affairs, FBM, Market Access, PAR) on regional/ local level
• Supports CTL to ensure issues are raised to Evidence team for timely action or mitigation.
  
  
  

Education And Requirements

Clinical Trial Manager Education/Experience Requirements:

• Bachelor's degree in life sciences or related field, advanced degree (MS, PhD, MD, PharmD) strongly preferred
• Bachelor's degree plus a minimum of six (6) years of experience in clinical research, preferably in the pharmaceutical industry
  
  
  

OR

• Master's degree or PharmD plus a minimum of four (4) years of experience in clinical research, preferably in the pharmaceutical industry
  
  
  

OR

• PharmD degree and completion of a 2-year clinical research fellowship, preferably in the pharmaceutical industry
  
  
  

OR

• PhD or MD plus a minimum of two (2) years of experience in clinical research, preferably in the pharmaceutical industry
  
  
  

Senior Clinical Trial Manager Education/Experience Requirements:

• Bachelor's degree in life sciences or related field, advanced degree (MS, PhD, MD, PharmD) strongly preferred
• Bachelor’s degree in Life Sciences or a related area plus a minimum of ten (10) years’ experience in clinical research, preferably in the Pharmaceutical industry
  
  
  

OR

• Master’s degree or PharmD plus a minimum of eight (8) years’ experience in clinical research, preferably in the Pharmaceutical industry
  
  
  

OR

• PhD or MD plus a minimum of five (5) years’ experience in clinical research, preferably in the Pharmaceutical industry
  
  
  

Role Requirements

Strong Communication Skills:

• Demonstrates AAI approach and skills in complex cross-functional matrix structures of the trial and extended team
• Articulates and aligns business strategy/plan on an ongoing basis, ensuring alignment between words and action
• Demonstrates active listening skills and cultural awareness
  
  
  

Scientific and Operational Expertise:

• Demonstrates scientific and therapeutic knowledge and operational expertise across all aspects of clinical trial planning and execution
• Dimensions of trial complexity include protocol, patients, sites, countries, vendors
  
  
  

Leadership and Influence:

• Demonstrates skills and capabilities in addressing complex situations, confidently setting direction for teams
• Demonstrates leadership behaviors of supporting, connecting and empowering teams, providing future direction, demonstrating visionary and innovative thinking and inspiring teams to achieve a common goal
• Executes activities with a clear aim to deliver value to patients
  
  
  

Strategic Mindset:

• Strategic and visionary thinker who is future focused, creative, courageous and able to navigate through ambiguity
• Integrates study strategy with overall TA portfolio
• Embraces cross functional initiatives, applying innovative learnings
• Is results-oriented with a global mindset using analytical thinking to provide risk-balanced solutions
  
  
  

Coordination and Oversight:

• Collaborative leader who demonstrates skills and capabilities in setting priorities, managing pace of activities, and efficient usage of resources
  
  
  

Project Management:

• Plans effectively, setting priorities, and defining actions
• Makes effective use of resources, and proactively strives for transparency and clarity to accomplish the business deliverables
• Translates complex situations to actionable parts
• Anticipates and resolves challenges and translates learnings to new projects
• Takes smart risks
  
  
  

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

This CTM position offers a base salary typically between $111,000 and $183,000 and the SR CTM positions offers a base salary typically between $135,000 and $232,000.  The position may be eligible for a role specific variable or performance-based bonus and or other compensation elements.  For an overview of our benefits please click here.