About the Company
Adagene Inc. (Nasdaq: ADAG) is a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. Adagene combines computational biology and artificial intelligence to design novel antibodies that address unmet patient needs. Powered by its proprietary DPL platform, composed of NEObody, SAFEbody, and POWERbody technologies, Adagene’s highly differentiated pipeline features novel immunotherapy programs. Adagene has forged strategic collaborations with reputable global partners that leverage its technology in multiple approaches at the vanguard of science.
The Clinical Trial Manager (CTM) drives the clinical trial execution activities for assigned clinical trials, and ensures trial deliverables are met according to timelines, budget, operational procedures, quality standards, GCP, SOPs and business guidelines.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Highly effective in the management of Clinical Research Organizations (CROs), specialty labs and vendor(s) as it relates to clinical program level deliverables and relationship with key CRO (functional and project) and vendor counterparts
- Track and report on progress of study site activation, patient enrollment, and monitoring visit activities and TMF maintenance. Serve as the liaison with internal and external groups to ensure effective and timely communication of study progress, action items and implementation plans
- Generates status reports of operational execution activities for management team
- May perform periodic oversight visits sites and/or vendors to assess progress and compliance. Ability to co-monitor site activities, perform site feasibility assessments
- May mentor in-house Clinical Research Associate(s) and/or Clinical Trial Coordinator(s)
- Reports study issues and recommended contingency plans to the line manager. Review and track trial budget activities including forecasting and reconciliation
- Accountable for timeliness and accuracy of trial information in all trial databases and tracking systems. Monitor performance of investigational sites and IP accountability and reconciliation process.
- Review key study metrics and determine appropriate actions in conjunction with the study team
- Manages vendor evaluation and onboarding activities and responsible for day-to-day management including setting expectations, training, managing timelines and deliverables, and issue management
- Liaises with legal and procurement on vendor, investigator, license, and other types of agreements
- Identifies and/or anticipates operational risks and mitigation plans within assigned clinical trials and escalates issues to Director of Clinical Operations as necessary
- Provides review and input to the clinical development plan and operational aspects of the clinical trial protocol. Develop study needed documents and plans
- Participates in the preparation and review of business processes and SOPs
- Other projects or responsibilities as may be required
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions of the job.
Minimum Qualifications – Education and Experience
- Bachelor or higher degree in the health or life sciences or equivalent
- 6-8 years of clinical research experience at a Biotech/Pharmaceutical or CRO company, at least 4 years of hands-on study management experience in oncology. Global trial experience a must
- Oncology experience required. CRA monitoring experience required
- Good communication and interpersonal skills in managing a cross-functional team
- Strong problem-solving capabilities
- Advanced understanding of study trial design, trial execution and operations
- Excellent organizational & time management skills and excellent computer skills required
- Work in a flexible remote environment that sometimes requires flexibility to meet early or late day so that interactions with global partners and staff can take place
- Sound working knowledge of the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory guidelines required
Equal Opportunity Employer
Adagene is an equal opportunity employer that is committed to diversity and inclusion. We prohibit discrimination and harassment of any kind based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, pregnancy, veteran status, or other legally protected characteristics as outlined by federal, state, or local laws. Learn more about your EEO Rights as an applicant.
Adagene will not discriminate or retaliate against applicants who inquire about, disclose, or discuss their compensation.
Adagene will consider for employment all qualified applicants with criminal histories in a manner consistent with applicable law. If you are applying for a position in San Francisco, review the San Francisco Fair Chance Ordinance guidelines applicable in your area.
Adagene participates in the E-Verify program in certain locations as required by law. Learn more about the E-Verify program.