Senior Manager, Clinical Operations

PTC Therapeutics - Warren, MI

Full-time - Senior

Warren, MI

Chemical Manufacturing

About the position

The Senior Manager, Clinical Operations is responsible for overseeing the scientific and operational aspects of clinical trials, ensuring compliance with regulatory requirements across various therapeutic areas. This role involves collaboration with internal teams and external partners to manage clinical studies from design to closeout, while also potentially managing direct reports.

Responsibilities

• Participates in the development of clinical strategy, trial design, and protocol development.
• Contributes to the development of study protocols, amendments, manuals, Informed Consent Forms, Case Report Forms, and Investigator Brochures.
• Estimates clinical study timelines using project management tools.
• Manages relationships with assigned investigator sites and vendors, including budget development and contract negotiations.
• Prepares and reviews investigator site lists for study inclusion.
• Plans and coordinates investigator meetings, developing and presenting agenda content.
• Oversees execution of activities related to clinical monitoring, safety, eligibility, enrollment, and data consistency.
• Conducts periodic reviews of clinical trial data for accuracy and consistency.
• Presents project progress reports at internal and investigator meetings.
• Maintains study-related documents and assists in interpreting clinical study results for reports and regulatory submissions.
• Addresses and resolves questions from sites and trial monitors regarding trial conduct.
• May manage, coach, and mentor direct reports.

Requirements

• Bachelor's degree in a scientific discipline.
• Minimum of 7 years of experience in clinical research in a pharmaceutical, biotechnology, CRO, or related environment.
• Comprehensive understanding of the drug development process and clinical trial design.
• Thorough knowledge of GCP and ICH guidelines.
• Demonstrated leadership ability and experience managing direct reports.
• Proficiency in Microsoft Word and Excel.
• Excellent oral and written communication skills, including scientific writing and presentation skills.
• Strong analytical and problem-solving skills.

Nice-to-haves

• Prior involvement in IND and NDA submissions.
• Previous clinical monitoring experience.
• Medical writing experience or training.
• Experience with Microsoft Project and PowerPoint.

Benefits

• Equal opportunity employer
• Commitment to diversity and inclusion