Senior Clinical Trial Manager

Barrington James

United States

Sur place

USD 113 900 - 187 800

Plein temps

14 jours+

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Avantages offerts par ce poste

Medical insurance

Pension plan

Tuition assistance

Disability insurance

401(k)

Résumé du poste

A leading biopharmaceutical company is seeking a Senior Clinical Trial Manager to oversee global clinical trials in rare diseases. The ideal candidate will have deep experience in clinical trial management, particularly in rare disease studies, with strong project management skills. This role is critical for ensuring compliance and successful trial outcomes in a fast-paced environment.

Qualifications

6–10+ years of clinical trial management experience in the biopharma industry.
3+ years of direct experience managing rare disease or orphan indication trials.
Strong ability to manage complex global trials.

Responsabilités

Lead the operational execution of complex clinical trials.
Develop and manage study timelines and budgets.
Oversee and manage CROs and vendor quality.

Connaissances

Project management

Leadership

Regulatory knowledge (ICH-GCP)

Stakeholder communication

Formation

Bachelor’s degree in Life Sciences

Advanced degree (MS, MPH, PhD, PharmD)

Description du poste

Direct message the job poster from Barrington James

We are seeking a highly motivated Senior Clinical Trial Manager (Sr. CTM) to lead the execution of global clinical trials in rare diseases. This individual will oversee study planning, execution, and reporting, ensuring that trials are conducted in accordance with regulatory requirements, GCP, and corporate timelines.

The ideal candidate will bring deep experience in rare disease clinical development, demonstrate strong project management capabilities, and thrive in a dynamic, fast-paced environment.

Key Responsibilities

Lead the operational execution of one or more complex clinical trials, from start-up through close-out, including vendor oversight, site management, and budget control.
Collaborate cross-functionally with Clinical Development, Regulatory, Medical Affairs, Biometrics, and other departments.
Develop and manage study timelines, enrollment strategies, risk mitigation plans, and clinical trial budgets.
Oversee and manage CROs, central labs, and other third-party vendors to ensure high-quality trial execution.
Participate in protocol development and contribute to clinical study documents including ICFs, CRFs, and monitoring plans.
Drive site selection, feasibility, and start-up activities, with an emphasis on reaching underserved patient populations.
Monitor study metrics and proactively identify and resolve operational issues.
Ensure all study activities are conducted in accordance with ICH-GCP, SOPs, and applicable regulatory requirements.
Support regulatory submissions and interactions, including INDs/CTAs and NDA/MAA filings.
Serve as a key point of contact for internal and external stakeholders regarding trial status and deliverables.
Mentor and guide junior clinical team members as needed.

Qualifications

Bachelor’s degree in Life Sciences or related field; advanced degree (MS, MPH, PhD, PharmD) a plus.
6–10+ years of clinical trial management experience in the biopharma industry.
3+ years of direct experience managing rare disease or orphan indication trials strongly preferred.
Demonstrated ability to manage complex global trials and multiple vendors.
Strong understanding of ICH-GCP, FDA and EMA regulations.
Experience with IND/CTA submissions and regulatory inspections is a plus.
Excellent leadership, organizational, and interpersonal skills.
Comfortable working in a fast-paced, evolving biotech environment.

Seniority level

Seniority level
Mid-Senior level

Employment type

Employment type
Full-time

Job function

Job function
Science and Research
Industries
Biotechnology Research, Pharmaceutical Manufacturing, and Research Services

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Inferred from the description for this job

Medical insurance

Pension plan

Paid paternity leave

Tuition assistance

Disability insurance

Vision insurance

Child care support

Paid maternity leave

Student loan assistance

401(k)

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