Senior Clinical Trial Manager

Disc Medicine; New York (NY); On-site; USD 150,000 - 190,000; Full time

Job summary

Disc Medicine seeks a Senior Clinical Trial Manager to lead the planning, execution, and closeout of large global clinical trials. The role involves managing CROs and vendors, maintaining regulatory compliance, and collaborating with cross-functional teams in a fast-paced biopharmaceutical environment.

Responsibilities include overseeing trial closeouts, selecting CROs, drafting essential documents, ensuring GCP audit readiness, and monitoring budgets and timelines across global studies.

Qualifications

• Bachelor's degree in any discipline.
• 7+ years of clinical trial management experience.
• Experience with global study management and GCP regulatory requirements.
• Strong written and oral communication skills.
• Experience managing CROs and external vendors.

Responsibilities

• Plan, execute, and oversee the closeout of global clinical trials.
• Evaluate, select, and manage CROs and external vendors.
• Write and review protocols, informed consent forms, and regulatory reports.
• Ensure trial master files meet GCP standards and audit readiness.
• Monitor progress, budgets, timelines, and identify risks.

Skills

Global study management

CRO management

Vendor management

GCP/regulatory knowledge

Communication skills

Education

Bachelor's degree in any discipline

Job description

Disc Medicine seeks a Senior Clinical Trial Manager to lead the planning, execution, and closeout of large global clinical trials. The role involves managing CROs and vendors, maintaining regulatory compliance, and collaborating with cross-functional teams in a fast-paced biopharmaceutical environment.

Responsibilities

• Plan, execute, and oversee closeout of one or more global clinical trials aligned with development strategyEvaluate, select, and manage CROs and external vendors for trial implementationWrite and review clinical documents including protocols, informed consent forms, and regulatory reportsEnsure trial master files and study documentation meet GCP standards and regulatory audit readinessMonitor clinical trial progress, manage budgets and timelines, and identify and mitigate risks

Requirements

• Bachelor's degree in any discipline7+ years of clinical trial management experienceExpertise in global study management and GCP regulatory requirementsStrong written and oral communication skillsExperience managing CROs and external vendorsAbility to work flexibly in small-company settings with changing priorities