Senior Clinical Trial Manager

Klein Hersh International; Boston (MA); Hybrid; USD 80,000 - 120,000; Full time

Job summary

An innovative firm is seeking a Senior Clinical Trial Manager to lead global clinical trials in the cardio-pulmonary area. This dynamic role requires a self-motivated individual who excels in a fast-paced environment and can adapt to changing priorities. You will manage trial start-up and execution while collaborating with internal and external stakeholders to ensure compliance with regulatory standards. Your leadership will guide a small team, fostering their professional growth while maintaining trial integrity. If you thrive in ambiguity and are passionate about advancing clinical research, this opportunity is perfect for you.

Qualifications

• 6+ years of experience managing global clinical trials, especially in cardio-pulmonary.
• Strong knowledge of GCP guidelines and regulatory requirements.

Responsibilities

• Manage start-up, execution, and close-out of global clinical trials.
• Collaborate with stakeholders to ensure trial integrity and compliance.

Skills

Clinical Trial Management

Regulatory Compliance (FDA, EMA)

Team Leadership

Stakeholder Engagement

Problem Solving

Interpersonal Communication

Organizational Skills

Education

Bachelor's Degree in Life Sciences

Advanced Degree (Preferred)

Job description

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)