Clinical Trial Manager
Company: ClinLab Solutions Group Agency
- Location: United States
- Work mode: Remote
- Seniority: Senior
- Employment type: Contract
- Posted: Yesterday
- Offer language: English
Job description
Job Title: Clinical Trial Manager
Work Location: REMOTE, USA
DURATION: 1 year contract, renewable
Summary:
Seeking an experienced Clinical Trial Manager to oversee the planning, execution, and management of global clinical trials in oncology and other therapeutic areas. This role involves collaboration with cross-functional teams and external partners to ensure successful trial delivery and compliance with regulatory standards.
Responsibilities:
- Design and implement global site management plans, including timelines, budgets, and resource allocation for clinical trials.
- Supervise site selection, initiation, and monitoring activities to ensure compliance with Good Clinical Practice (GCP) and regulatory requirements.
- Coordinate with external vendors such as CROs and laboratories to ensure timely and high-quality study deliverables.
- Manage essential trial documentation, including protocols, informed consent forms, and regulatory submissions.
- Identify risks, implement mitigation strategies, and address issues to maintain data integrity and trial validity.
- Act as the main contact for investigative sites, offering guidance and support throughout the study duration.
- Serve as a subject matter expert for clinical systems such as eTMF and CTMS as needed.
- Drive process improvements and contribute to best practices within the clinical operations function.
Qualifications:
- Bachelor’s degree in life sciences or a related field.
- 6+ years of clinical trial management experience in the pharmaceutical, biotechnology, or CRO industry.
- Experience managing Phase 1-3 oncology clinical trials is required.
- Proven track record in global trial management across multiple phases.
- Direct experience overseeing global CROs and study vendors.
- Strong attention to detail and organizational skills.
- 3+ years of on-site monitoring experience preferred.
- Excellent written and verbal communication skills.
- Ability to work collaboratively in a small, dynamic team environment and fill functional gaps as needed.
- Demonstrated ability to set priorities, work with urgency, and manage relationships effectively.
- Creative problem-solving abilities and adaptability in a fast-paced setting.
- Proficiency with Microsoft Office, CTMS, eTMF, IRT, and EDC platforms.
- Experience working cross-culturally and across multiple time zones.
- Ability to work independently, prioritize tasks, and adapt to changing priorities.
