What are the responsibilities and job description for the Senior Clinical Trial Manager position at peptilogics?
About Peptilogics: Leaders in Scalable, Rational Design
Peptilogics is a clinical-stage biotechnology company that designs and develops novel peptide therapeutics. The company leverages machine learning, automation, and peptide synthesis to build platforms for science at scale. With its foundations in drug development and engineering, the company’s platforms vertically integrate proprietary hardware, software, bioinformatics, chemistry, and molecular biology to advance basic research, target validation, and clinical trials.
Position Overview
The Senior Clinical Trial Manager (CTM) oversees the planning, execution, and completion of clinical trials to ensure they meet regulatory standards, timelines, and budget constraints. Oversees vendors with a focus on ensuring project and program objectives are being met. This role is pivotal in ensuring the integrity and success of clinical research studies.
Essential Functions
- Manage day-to-day operations of clinical trials, working closely with both the internal cross-functional study team and with the CRO team members
- Lead internal team meetings to provide study status updates
- Review study budgets and invoices. Track financial spending across vendors.
- Serve as the CRO primary point of contact for all day-to-day activities, including study startup, monitoring, site management, and close-out activities
- Monitor, track and report site and study performance metrics, budget and timelines. Review with Clinical Operations team and take needed steps to ameliorate when needed.
- Review monitoring trip reports and provide feedback to CRO as needed
- Ensure compliance with Good Clinical Practice (GCP), ICH, and regulatory requirements
- Serve as the Vendor point of contact for select vendors, ensuring deliverables are complete, of high quality and provided on time
- Provide regular updates and reports to stakeholders
- Oversee study team training records and ensure team members maintain current training status throughout the study
- Review TMF files to ensure TMF is complete and inspection ready
- Ensure study operations are compliant with study plans
- Work with the Sponsor and CRO teams to prioritize data integrity and participant safety
- Continuously monitor for quality issues and implement quality control measures as needed
- Perform other duties as assigned
Required Qualifications and Skills
- Bachelor’s degree in life sciences, health sciences, or related field (Master’s preferred)
- 3–5 years of experience in clinical research with a strong history of trial management
- Strong knowledge of GCP, FDA regulations, and ICH guidelines
- Certification (e.g., CCRP, CCRA, PMP) is often preferred
- Familiarity with GCP training and certification preferred
- Excellent clinical research project management and organizational skills
- Excellent interpersonal skills, integrity, and professionalism
- Ability to operate effectively in a fast-paced, dynamic environment with shifting priorities
- Strong communication and leadership abilities
- Proficiency in timeline management
- Ability to manage multiple deadlines simultaneously
- Proficiency in Microsoft Office applications (Word, Excel, PowerPoint)
Desirable Qualifications and Skills
- Startup company clinical trial leadership experience preferred
Our Commitment to Equal Opportunity
Peptilogics is proud to be an equal opportunity employer. We make hiring decisions based on qualifications, experience, and potential—without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected status. We welcome candidates from all backgrounds to apply.