Senior Clinical Trial Manager

Contact: Jim Sonnon
Phone: (267) 387-0090

Position Overview

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)

Location(s)

If interested, please send a MS Word version of your resume to [email protected]

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