- Clinical operations functional activities related to the execution of assigned clinical trials based upon department and corporate goals and objectives
- Management of clinical studies and vendors to ensure studies are completed on time, within budget, and in compliance with Standard Operating Procedures (SOPs), FDA regulations, and International Council for Harmonization (ICH)/ GCP guidelines.
- Identify, engage, and manage the activities of clinical CROs and other clinical study providers (e.g., core labs, Electronic Data Capture (EDC) providers, and independent contractors) to execute clinical trials.
- Review and contribute to developing study-specific documentation, including clinical trial protocols, case report forms, study guides/manuals, informed consent forms, and clinical databases.
- Review monitoring reports and other study documentation as required.
- Oversee the collection and management of clinical trial documentation to be filed in the Trial Master File (TMF).
- Participate in team meetings and collaborate with other functional groups within the company (e.g., Clinical Development, Pharmacokinetics, Quantitative Sciences, Regulatory, QA, Finance, Legal, etc.) to achieve clinical study goals.
- Follow up on assigned team action items and identify, escalate, and resolve issues as needed.
- Collaborate with contracts specialists to review and negotiate Clinical Trial Agreements and site-specific study budgets.
- Assess the adequacy and feasibility of potential clinical investigators and sites, including evaluating facilities, personnel, patient referral base, and adherence to GCP.
- Development of clinical study monitoring priorities and Monitoring Plan in conjunction with CRO
- Conduct site visits (e.g., training visits, site initiation visits, monitoring visits) as required.
- Manage investigational product accountability and reconciliation processes.
- Assist with preparing safety, interim, and final clinical study reports and resolving data discrepancies.
- Provide clinical trial support, mentoring, leadership, guidance, and direction to Clinical Research Associates (CRAs) assigned to clinical studies.
- Prepare and track study participant enrollment projections against actuals and study budgets.
- Serve as the primary clinical operations contact for internal and external (clinical sites, vendors, etc.) teams for assigned studies.
- B.S. or M.S. degree with a minimum of 3 years of clinical operations experience in the pharmaceutical or biotech industry, preferably the majority in oncology drug development
- Hands-on experience in running early-stage clinical trials within an industry environment
- Experience with clinical trial operations outside the USA is desired.
- Strong working knowledge of FDA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials
- Experience in the selection of CROs/vendors and management of external resources.
- Experience in working with cooperative group studies and investigator-sponsored trials is preferred.
- Demonstrated record of strong vendor management and teamwork
- Direct experience in managing clinical CROs
- Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
- Excellent written and verbal communication skills
- Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute goals as a member of an interdisciplinary team
- Able to travel (~25%)
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Senior Clinical Trial Management Associate - Fremont, United States - Bayside Solutions
Description
Senior Clinical Trial Management Associate
W2 Contract
Salary Range: $145,600 - $156,000 per year
Location: Redwood City, CA - Hybrid Role
Job Summary:
As a Senior Clinical Trial Management Associate, you will be responsible for Contract Research Organization (CRO) oversight and execution of clinical studies. This role is an opportunity for an experienced Clinical Operations Professional with technical expertise supporting Phase I-III clinical trials in an industry setting and a strong knowledge of clinical operations, Good Clinical Practice (GCP), and U.S. Food and Drug Administration (FDA) regulatory requirements.
Duties and Responsibilities:
Requirements and Qualifications:
Desired Skills and Experience
Clinical trial, Phase I-III, oncology, drug development, CRO, FDA, ICH Guidelines, GCP, TMF
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