Clinical Trial Manager / Senior - On-site

Boehringer Ingelheim International - Ridgefield, CT

Full-time - Mid Level

Hybrid - Ridgefield, CT

Merchant Wholesalers, Nondurable Goods

About the position

The Clinical Trial Manager (CTM) at Boehringer Ingelheim is responsible for the operational and scientific oversight of clinical trials, ensuring compliance with regulations and protocols. This role involves planning, executing, and delivering clinical trials, with a focus on patient and site engagement. The CTM leads the trial team, communicates with stakeholders, and manages trial activities to achieve defined milestones and performance indicators. This position requires a hybrid work model, with on-site presence in Ridgefield, CT, 2-3 days per week.

Responsibilities

• Accountable for trial activities for responsible R/OPU, ensuring compliance with GCP-ICH and local/global regulations.
• Create, manage, and review the R/OPU trial budget for financial oversight and planning accuracy.
• Ensure timely budget updates based on trial changes and conduct appropriate trial-specific training.
• Plan and coordinate operational feasibility of trial timelines and ensure alignment among trial team members.
• Verify and provide input into country and site level feasibility and OPU commitment.
• Finalize and validate site selection in collaboration with other functions.
• Develop and implement country level engagement plans, recruitment planning, and risk mitigation strategies.
• Coordinate development of patient-facing documents in collaboration with stakeholders.
• Report patient and site feedback to improve trial design with a focus on patient value.
• Oversee outsourcing of vendor services in accordance with operating models and governance.
• Maintain oversight during clinical trial conduct, ensuring adherence to GCP and regulatory requirements.
• Monitor progress of patient recruitment endpoints and update contingencies throughout trial conduct.
• Establish and maintain relationships with external experts and investigational sites.
• Ensure timely cleaning and delivery of clinical trial data and compliant archiving of documents.
• Share information on trial results with investigational sites and patients.

Requirements

• Bachelor's degree in life sciences or related field; advanced degree (MS, PhD, MD, PharmD) strongly preferred.
• Minimum of six years of experience in clinical research for Bachelor's degree holders; four years for Master's degree or PharmD holders; two years for PhD or MD holders.

Nice-to-haves

• Experience in Oncology therapeutic area is preferred.
• Strong leadership and communication skills.

Benefits

• Competitive compensation and benefit programs.
• Opportunities for international collaboration and networking.
• Support for work-life balance and diversity and inclusion initiatives.