Klein Hersh International
Senior Clinical Trial Manager
Klein Hersh International, Boston, Massachusetts, us, 02298
Our client is seeking a dynamic and experienced Senior Clinical Trial Manager. This role requires a self-motivated person who can manage the start-up and execution of large, global clinical trials. The ideal candidate thrives in a fast-paced, small-company environment where daily activities can fluctuate, requiring flexibility and the ability to navigate ambiguity.
Key Responsibilities
Manage the start-up, execution, and close-out of global clinical trials, particularly in the cardio-pulmonary therapeutic area. Actively participate on cross-functional teams to ensure clinical trial timelines, budgets, and quality objectives are met. Collaborate closely with internal and external stakeholders, including CROs, investigators, and vendors, to maintain trial integrity and mitigate risks. Ensure all activities are conducted in accordance with ICH guidance and are compliant with FDA and EMA regulatory requirements. Support trial site selection, initiation, monitoring, and closure across multiple regions, with a focus on Europe and the U.S. Act as a key point of contact for trial sites, investigators, and vendors. Ensure all stakeholders are put in a position to succeed. Manage a small team of Clinical Trial Associates, providing mentorship and guidance to support their professional growth. Proactively identify and resolve issues that arise during the course of the trials, maintaining a sense of urgency and attention to detail. Support trial-related audits and inspections as needed, ensuring complete and accurate documentation is available. Key Requirements
Bachelor’s degree in Life Sciences, Nursing, or a related field (Advanced degree preferred). Minimum of 6 years of experience managing global clinical trials, with a strong focus on cardio-pulmonary indications. Proven experience in FDA and EMA-regulated clinical trials, with expert working knowledge of GCP guidelines. Previous experience working at a small company, with the ability to adapt to changing priorities and a dynamic work environment. Demonstrated success in managing teams, including mentoring Clinical Trial Associates or similar roles. Strong interpersonal and communication skills, with the ability to engage stakeholders and operate effectively under tight timelines. Excellent organizational skills, with attention to detail and problem-solving abilities. A willingness to help grow our client's culture and community Prior experience with trial sites in Europe is preferred Experience working with both CRO-managed and in-house trials is preferred Location: Boston (Hybrid; Tue-Thur in office)
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Manage the start-up, execution, and close-out of global clinical trials, particularly in the cardio-pulmonary therapeutic area. Actively participate on cross-functional teams to ensure clinical trial timelines, budgets, and quality objectives are met. Collaborate closely with internal and external stakeholders, including CROs, investigators, and vendors, to maintain trial integrity and mitigate risks. Ensure all activities are conducted in accordance with ICH guidance and are compliant with FDA and EMA regulatory requirements. Support trial site selection, initiation, monitoring, and closure across multiple regions, with a focus on Europe and the U.S. Act as a key point of contact for trial sites, investigators, and vendors. Ensure all stakeholders are put in a position to succeed. Manage a small team of Clinical Trial Associates, providing mentorship and guidance to support their professional growth. Proactively identify and resolve issues that arise during the course of the trials, maintaining a sense of urgency and attention to detail. Support trial-related audits and inspections as needed, ensuring complete and accurate documentation is available. Key Requirements
Bachelor’s degree in Life Sciences, Nursing, or a related field (Advanced degree preferred). Minimum of 6 years of experience managing global clinical trials, with a strong focus on cardio-pulmonary indications. Proven experience in FDA and EMA-regulated clinical trials, with expert working knowledge of GCP guidelines. Previous experience working at a small company, with the ability to adapt to changing priorities and a dynamic work environment. Demonstrated success in managing teams, including mentoring Clinical Trial Associates or similar roles. Strong interpersonal and communication skills, with the ability to engage stakeholders and operate effectively under tight timelines. Excellent organizational skills, with attention to detail and problem-solving abilities. A willingness to help grow our client's culture and community Prior experience with trial sites in Europe is preferred Experience working with both CRO-managed and in-house trials is preferred Location: Boston (Hybrid; Tue-Thur in office)
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