Clinical Trial Manager

Overview

Trial Preparation

• Ensure trial compliance with GCP-ICH, local/global regulations, SOPs, and protocol by overseeing Contract Research Organisation (CRO) and internal teams.
• Manage and review R/OPU trial budget; update as needed for accuracy and oversight.
• Conduct trial-specific training for internal and external partners per the Trial Training Plan.
• Plan and coordinate operational feasibility and timelines; align and track trial team progress.
• Validate site feasibility and commitments; finalize site selection with cross-functional input.
• Develop and implement country-level engagement, recruitment, and risk mitigation plans; coordinate patient-facing documents and report feedback for trial improvement.
• Frontload activities at R/OPU level to drive efficiency and speed.
• Oversee vendor outsourcing per operating models and governance.
• Respond promptly to Regulatory Authority/Ethics Committee and external stakeholder queries.
• **Trial Conduct**
• Maintain oversight of trial conduct, ensuring GCP and regulatory compliance, SOP adherence, and risk monitoring.
• Oversee budget, quality monitoring, and safety reporting in collaboration with other functions.
• Monitor patient recruitment progress; proactively manage contingencies.
• Support Clinical Trial Lead (CTL) during investigator meetings.
• Build and maintain relationships with external experts, sites, Patient Organizations, and stakeholders; coordinate cross-functional collaboration.
• Actively participate in CDO community and CTM network to promote functional excellence.
• **General accountabilities**
• Build and maintain 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.
• Establish and maintain relationships with external experts, investigational sites, Patient Organizations and other stakeholders by coordinating and ensuring cross-functional collaboration amongst CDO and appropriate functions (i.e. Medical Affairs, Market Access, PAR) on regional/ local level.
• Supports CTL to ensure issues are raised to Evidence team for timely action or mitigation.
• Manage vendors and CROs to ensure high-quality study conduct
• **Requirements:**
• Bachelors or Master’s degree required, preferably in Biomedical Sciences, with relevant professional experience.
• Minimum of 3 years’ proven experience in clinical trial project management.
• In-depth understanding of clinical trial management, with a strong emphasis on teamwork to promote high-performance teams.
• Demonstrated ability to manage multiple studies in a fast-paced environment
• Experience in Therapeutic Areas relevant in Boehringer Ingelheim’s pipeline is desirable, including Cardiovascular-Renal-Metabolic, Inflammation and Oncology
• Understanding of key local/regional major regulations, including India, Turkey, South Africa and Saudi Arabia.

Experience

• d in working with CROs and external partners is desirable
• **Skills and Competencies:**
• Strong ability to build and maintain strong relationships of mutual value
• Familiarity with clinical guidelines and standard of care is desirable
• Familiarity with Veeva Vault is desirable
• **What happens Next?**
• We are looking forward to receiving your application!
• We will then have a look at your CV.
• If we see a match, we will invite you for a screening interview.

SPL Screening