Associate Clinical Trial Manager
San Diego, Canada • Penuh Waktu
Jadilah yang pertama mendaftar
- Pengalaman
- 1–2 tahun
- Gaji
- USD 122,000 – USD 137,000 / year
- Lowongan
- 1
- Diposting
- 2 jam yang lalu
- Mode kerja
- Di kantor
- Pendidikan
- Bachelor's degree in Biological Sciences or allied health fields preferred
- Melanjutkan
- Wajib mendaftar
Tempat Anda akan bekerja
Deskripsi pekerjaan
About Erasca, Inc.
Erasca, Inc. is a clinical-stage precision oncology company dedicated to discovering, developing, and commercializing therapies for cancer patients. Our programs focus on innovative strategies to inhibit the RAS/MAPK signaling pathway, which is mutated in millions of people worldwide each year. The company's name symbolizes our bold mission to eradicate cancer.
Position Overview
As an Associate Clinical Trial Manager (aCTM), reporting to the Senior Clinical Project Manager of Clinical Operations, you will support the execution and management of clinical research projects from start-up through study close-out. Your duties involve oversight of clinical vendors, contract research organizations (CROs), timelines, budgets, and resource allocation. You will also maintain and control the quality of Trial Master File (TMF) activities managed by the CRO.
Key Responsibilities
- Coordinate or aid in managing global oncology clinical trials (Phases 1-3) to ensure adherence to protocols, ICH GCP, and local regulations.
- Support critical study-related milestones and deliverables.
- Assist with training initiatives to guarantee that team members comply with protocols and study documentation.
- Monitor study progress and maintain updates on site selection, IRB approvals, regulatory documentation, enrollment, source data verification, drug inventory, and specimen tracking.
- Provide regular status reports and strategies for resolving challenges such as trial issues, feedback from investigators or coordinators, monitoring difficulties, and patient enrollment barriers.
- Manage and support the electronic Trial Master File (eTMF) modules and workflows.
- Control user access, permission roles, and document indexing per ICH-GCP guidelines and company SOPs.
- Review CRO documentation filing practices, ensuring timely resolution of missing or non-compliant files in collaboration with study teams.
- Prepare for regulatory and sponsor audits by facilitating document retrieval and addressing corrective actions.
- Occasionally conduct monitoring visits alongside CRO during various study stages.
- Perform all duties aligned with company values, policies, and regulatory requirements.
Required Qualifications and Experience
- Preferably holds a bachelor's degree in Biological Sciences or allied health fields (pharmacy, medicine, nursing, etc.) with 1-2 years relevant experience.
- 1-2 years in clinical operations within pharmaceutical companies or CROs, involving trial set-up, monitoring, and close-out for US and international Phase 1-3 trials.
- Experience (1-2 years) with TMF/document management or clinical trial support activities.
- Familiarity with electronic TMF systems such as Trial Interactive or Veeva Vault.
- Proven ability to successfully support multiple clinical projects and priorities simultaneously.
- Preferred experience managing study vendors including CROs, IRT/IXRS, central labs, and CTMS/eTMF providers.
- Strong understanding and applied knowledge of ICH-GCP and US/non-US regulatory guidelines.
- Ability to collaborate effectively with global, multidisciplinary teams.
- Self-motivated, able to excel in a fast-moving, entrepreneurial environment.
- Strong organizational, oral, and written communication skills.
- Continuous learner with a commitment to science and patient welfare.
Compensation and Benefits
The annual salary range is $122,000 to $137,000, dependent on experience and qualifications. Additional compensation includes annual bonuses and equity grants in the form of stock options. Benefits encompass paid time off, holidays, sick leave, comprehensive medical, dental, and vision insurance, disability plans, life and AD&D coverage, flexible spending accounts, critical illness and accident insurance, pet insurance, employee assistance programs, 401(k) with company match, and an employee stock purchase program.
Diversity & Inclusion
Erasca is proud to be an Equal Opportunity Employer, committed to maintaining a diverse and inclusive workplace. Employment decisions are made without regard to legally protected characteristics such as sex, race, religion, national origin, disability, age, sexual orientation, or veteran status.