Manager, CRO Coordination & Documentation

Position Summary:

City Therapeutics is seeking a highly organized and detail-oriented CRO coordinator and manager to join our Translational Sciences team. The individual will serve as the primary point of contact for external partners, coordinate CRO activities (e.g. contract setup, protocol development, sample shipment, and report generation), and manage nonclinical regulatory documentation (CTA/IND).

The successful candidate will play a central role in advancing programs toward clinical development by providing end-to-end operational oversight for both external and internal nonclinical studies, ensuring scientific quality, regulatory compliance, and timely delivery of results. Prior experience on bioanalytical assay development, qualification, and validation, and/or monitoring of toxicology studies and/or ADME studies is a plus. This role will collaborate closely with internal scientists, regulatory, and project management teams, serving as the operational bridge between City Therapeutics and its CRO partners.

Key Responsibilities:

CRO management and Oversight:

• Serve as the primary point of contact for CROs, ensuring seamless setup and execution of nonclinical studies (e.g. toxicology, pharmacology, bioanalytical, ADME) and clinical PK and PD sample analysis.
• Partner with in-house stakeholders to support study conduct.
• Monitor CRO study execution from protocol development through reporting and archiving, ensuring GLP compliance and data quality.
• Ensure external study timelines are tracked and aligned with internal program milestones.
• Travel to CRO sites to perform technical assessments, monitor key study phases and prepare site visit reports to document observations and follow-up actions.

Internal Study Support:

• Coordinate and monitor the conduct of internal nonclinical studies, ensuring activities adhere to protocols, timelines, and quality standards.
• Support logistics for sample management, data collection, and study documentation.
• Facilitate communication between internal scientists, project managers, and leadership.

Study Tracking & Logistics:

• Manage operational activities including contracting studies, reviewing and executing SOWs, generating study and PO numbers, and coordinating with Finance/Legal as needed.
• Coordinate test article and sample shipments to and from CROs, ensuring proper storage before, during, and after delivery.
• Oversee financial tracking by monitoring installment-based study invoices, ensuring accuracy, timely approvals, and budget alignment.

Documentation & Compliance:

• Coordinate and manage internal study document QC reviews and approval.
• Conduct QC review of external study protocols, protocol amendments, and study reports, ensuring sections are accurate, complete, and submission ready.
• Assist in preparing nonclinical components of regulatory submissions (e.g., IND, CTA, IB).
• Ensure compliance with internal SOPs, GLP standards, and regulatory guidelines (FDA, EMA, ICH).

Qualifications:

• Ph.D. (3+ years), MS (6+ years) or BS (8+ years) in life sciences, biotechnology, pharmacology, or related field in nonclinical development (or Translational Sciences), CRO/vendor coordination, or related operations.
• Prior experience in bioanalytical assay development and validation.
• Demonstrated experience working with GLP-compliant CROs and/or managing GLP/non-GLP studies in a biotech or pharmaceutical setting is required.
• Strong organizational skills with attention to detail and the ability to manage multiple projects simultaneously.
• Excellent written and verbal communication skills, with the ability to build strong vendor and internal relationships.
• Willingness to travel to CRO sites as needed.
• Comfortable working in a fast-paced, highly collaborative environment.
• Experience in toxicology study monitoring or outsourcing ADME studies or document managements is a plus.
• Please note this role is required to be on-site at our offices in Cambridge, MA 5 days a week.

Join us as a core member of our Translational Sciences team and play a critical role in advancing our pipeline toward the clinic and beyond.

City Therapeutics is accepting resumes/CVs from direct applicants only.  Recruitment Agency submissions will not be accepted at this time.

City Therapeutics is an Equal Opportunity and Affirmative Action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.