Drop off your CV/Resume
We'd love to hear from you. Send us your CV/Resume and one of our team will be in touch.
Associate Director Clinical Operations Oncology remote
148692
Posted:
20/08/2024th
20/08/2024
- 185000 USD - 185000 USD
- Hayward, United States
- Permanent
Associate Director, Clinical Operations – Oncology
Location: Remote (U.S.)
Are you an experienced clinical operations professional with a passion for oncology? We are seeking an Associate Director, Clinical Operations to lead and oversee various aspects of our clinical trials. This role ensures that trials are executed efficiently, adhering to standard operating procedures (SOPs), regulatory guidelines, and company objectives.
As the Associate Director, you will work closely with internal teams, external vendors, and clinical study sites. Your responsibilities will include managing trial operations, coordinating with Contract Research Organizations (CROs), and ensuring compliance with Good Clinical Practices (GCP) and relevant regulations.
Key Responsibilities:
- Operational Oversight: Manage the operational elements of clinical trials, including project plans, timelines, budgets, and resources.
- Vendor Management: Oversee interactions with CROs, including their functional activities such as study management and site management.
- Protocol Development: Contribute to the development of protocols, Case Report Forms (CRFs), Clinical Study Reports, and regulatory submissions.
- Risk Management: Identify and address potential issues or risks associated with clinical studies and recommend or implement solutions.
- Metrics & Reporting: Prepare and present metrics and updates to management.
- CRO/Vendor Selection: Participate in the selection process and work with vendors to develop and revise service agreements, budgets, and timelines.
- Compliance: Ensure compliance with GCP and relevant regulations through effective management of clinical monitoring activities.
- SOP Development: Contribute to the development and implementation of departmental SOPs and processes.
- Innovative Solutions: Recommend and implement innovative ideas to enhance clinical trial management.
- Meeting Management: Organize and manage internal team meetings, investigator meetings, and other trial-specific meetings.
- Documentation: Review study-related documents, including monitoring plans, laboratory manuals, patient diaries, and site contracts.
- Team Management: Participate in the selection, training, and evaluation of study personnel, and potentially manage clinical operations staff.
Requirements:
- Bachelor’s degree in a relevant field.
- Minimum of 7 years of experience in clinical trial management, with a focus on oncology preferred.
- Proven experience managing external vendors, including CROs.
- Strong understanding of clinical research operations and regulations, including FDA guidelines and ICH standards.
- Excellent written and verbal communication skills with strong analytical and problem-solving abilities.
- High attention to detail and proficiency in Microsoft Office Suite.
This is a remote position open to candidates across the U.S. If you’re ready to make a significant impact in oncology clinical trials, we’d love to hear from you!
Martin Wenzel
Division Director