Senior Clinical Trial Manager / Clinical Trial Manager
Bayside Solutions · San Mateo County, CA · 4 wk ago
HybridProject Management$77–$84/hrFull-time
Duties and Responsibilities
- Manage the implementation, on-time execution, and conduct of clinical study(ies), including the development of study plan(s), key milestones, timelines, study costs, and vendor selection while ensuring the highest level of quality and compliance.
- Prepare and deliver accurate and timely study updates, metrics, and reports to senior management.
- Ability to identify potential risks that may impact the study(ies), e.g., study data, ethical conduct, and adherence to ICH guidelines, and provide risk mitigation solutions.
- Appropriately manage the various stages of study activities, e.g., start-up, treatment, maintenance, and close-out, to ensure the study is conducted on time and within budget.
- Understand the data requirements of clinical study(ies) to ensure quality and integrity of data during collection, review, cleaning, and monitoring.
- Perform responsibilities with a high degree of independence while effectively partnering with team members to meet deliverables and deadlines.
Requirements and Qualifications
- Effective team player with exceptional written and interpersonal communication skills.
- Demonstrated aptitude for strategic and flexible thinking, with the ability to anticipate challenges, evaluate alternatives, and adjust strategies as needed.
- Proven ability to manage delegated aspects of clinical trials, leveraging strong planning, organizational, and time-management skills.
- Ability to manage CROs and clinical study vendors.
- Ability to collaborate with cross-functional clinical study teams.
- Strong working knowledge of FDA & ICH/GCP regulations and guidelines, and ability to translate into inspection readiness at all times.
- Proficiency in MS Office, including Word, Excel, PowerPoint, and other applications; demonstrated experience in technical writing.
- Travel Requirements: domestic and/or international up to 25%.
- BS/BA in Life Sciences or related discipline.
- 3-5 years of experience in clinical and drug development.