Sr. Clinical Trial Manager (Sr. CTM)

Ascentage Pharma; United States; On-site; USD 100,000 - 140,000; Full time

Benefits offered by this job

Competitive benefits package

Generous PTO and holidays

Flexible work arrangements

Job summary

A global clinical-stage biotechnology company is seeking a Clinical Trial Manager to oversee Phase I-III clinical trials. Responsibilities include managing trial operations, ensuring compliance with regulations, and collaborating with CROs. The ideal candidate has at least six years of clinical trial experience and a strong background in oncology. The position is eligible for remote work anywhere in the US.

Qualifications

• Minimum six years of clinical trial/operations experience.
• Strong project management skills and ability to deliver results.
• Experience in oncology Phase 1-2 trials preferred.
• Experience in oncology Phase 1-2 trials and vendor contract management desirable.
• Solid vendor management skills (CRO, lab, clinical supply logistics).
• Knowledge of FDA/EU regulations, GCP/ICH guidelines; IND safety reporting.

Responsibilities

• Oversees clinical investigations by conducting site evaluations.
• Participates in planning, implementation, and management of trials.
• Tracks, monitors, and reports study progress.
• Prepare documents (ICFs, CRFs, monitoring plans) and ensure regulatory compliance.
• Oversee site monitoring and TMF maintenance; ensure audit readiness.

Skills

Project management

Clinical trial operations

Regulatory compliance

Vendor management

Attention to detail

Attention to detail

Education

Bachelor’s or Master’s degree in nursing, life sciences, or related field

Tools

Microsoft Office

TMF maintenance

Microsoft Office

Job description

Overview

Ascentage Pharma (Nasdaq: AAPG and HKEX: 6855) is a global, clinical-stage biotechnology company developing novel therapies for cancer and other diseases. We are a dynamic, fast-paced organization with a collaborative culture focused on advancing therapeutics that positively impact patients’ lives. Locations include the USA, China, UK and Australia, with expertise in structure-based drug design and an innovative drug discovery engine.

The Opportunity: Clinical Trial Manager

Position Summary

Participates in the preparation and execution of Phase I-III clinical trials. Oversees clinical investigations by conducting site evaluation, initiation, and interim close-out visits to sites. Monitors clinical trials following Good Clinical Practices and Ascentage Pharma procedures. Works closely with the Clinical Trial Manager and/or Lead CRA to ensure all monitoring activities align with study requirements.

Responsibilities

• Participates in planning, implementation, and management of Phase I- II clinical trials in collaboration with CRO partners, including project timelines, quality of deliverables, and management of approved trial budgets.
• Contributes to development of RFPs, participates in CRO/vendor selection, and manages CRO/vendor activities to meet deliverables and timelines. May train CROs, vendors, investigators, and study coordinators on study requirements. Maintains regular contact with CROs to monitor performance and provide guidance.
• Participates in executing a clinical trial from protocol design to final study report; contributes to protocol development and clinical study reports.
• Prepares and coordinates review/distribution of documents (e.g., informed consent forms, case report forms, monitoring plans, monitoring reports).
• Implements operational procedures for assigned projects and collaborates with internal and external teams to ensure regulatory compliance and GCP/ICH adherence.
• Oversees site adherence to regulations through review of monitoring reports, audit reports, investigator communications, and CRO/designee personnel.
• Participates in site selection with clinical/medical operations and vendors; identifies risks and resolves issues with minimal supervision.
• Maintains study timelines (including recruitment) and contributes to study budgets and site-level budgets; manages expenditures and spending trends.
• Tracks, monitors, and reports study progress; ensures TMF is audit-ready and addresses audit observations promptly.
• Provides leadership and guidance to other clinical operations staff as needed; contributes to development of departmental processes, procedures, and guidelines.
• Complies with health, safety and environmental policies; performs other duties as requested.

Knowledge/Skills/Abilities

• Bachelor’s or Master’s degree in nursing, life sciences, or related field, or equivalent
• Minimum six years of clinical trial/operations experience, including at least five years in clinical project management in a biopharmaceutical setting
• Strong project management skills; ability to deliver results in a fast-paced environment
• Experience in oncology Phase 1-2 trials preferred; prior clinical monitoring and vendor contract management experience desirable
• Solid vendor management skills (CRO, lab, clinical supply logistics); familiarity with insourced/outsourced studies
• Thorough knowledge of clinical research operations, FDA/EU regulations, GCP/ICH guidelines; knowledge of IND safety reporting
• Attention to detail, strong organizational and communication skills; ability to lead cross-functional teams and interface with clinical site personnel
• Ability to write/edit protocols, amendments, informed consent forms, and other trial-related documents
• Ability to manage multiple priorities across complex trials in a matrix environment
• Knowledge of electronic data capture and TMF maintenance; proficient in Microsoft Office

Location

• Based in Rockville, MD, USA, with the position eligible to be remote anywhere in the US.

Culture

We strive for a culture that supports personal and professional growth with a focus on collaboration, diversity, and patient-centric science. We aim to empower and develop our employees in a diverse, multidisciplinary environment.

Why Join Us – Our Value Proposition

This role offers the opportunity to shape the clinical vision of a public biotech at a pivotal growth moment, with a meaningful impact on patients. We seek exceptional people, provide resources and flexibility to thrive, and support impactful work in cancer therapeutics.

What We Offer

• Exciting, global work environment with competitive benefits (medical, dental, vision, disability, life insurance; STD/LTD; 401(k) with immediate vesting).
• Generous PTO and holidays with floating holidays; career growth through training and conference attendance.
• Commitment to engagement, diversity, inclusion, and empowerment; flexible work arrangements (onsite, remote, or hybrid).

Compensation

At Ascentage, base pay is part of a total rewards package that includes comprehensive benefits and eligible bonuses/equity. Actual pay is determined by location, experience, skills, education, and internal equity.

About Ascentage Pharma

Ascentage Pharma is a globally focused, clinical-stage biotechnology company developing novel therapies for cancer, CHB, and age-related diseases. In January 2025, Ascentage went public on NASDAQ. In July 2025, we announced the approval of Lisaftoclax by China’s NMPA for chronic lymphocytic leukemia/small lymphocytic lymphoma.