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Senior Clinical Operations Manager
2 months ago
Position: Clinical Trial Manager / Senior Clinical Trial Manager
Employment Type: W2 Contract-to-Hire
Compensation: $156,000 - $187,200 annually
Work Arrangement: Hybrid or Remote (PST)
Overview:
This position offers a distinctive opportunity for a seasoned Clinical Operations Professional with substantial expertise in overseeing Phase I-III clinical trials within a corporate environment. The ideal candidate will possess a comprehensive understanding of clinical operations, Good Clinical Practice (GCP), and the regulatory standards set forth by the US Food and Drug Administration (FDA). As a Clinical Program Manager, you will play a pivotal role in managing Contract Research Organizations (CROs) and ensuring the successful execution of clinical studies.
Key Responsibilities:
- Oversee clinical operations activities related to the implementation of assigned clinical trials, aligning with departmental and corporate objectives.
- Direct clinical studies and vendor relationships to guarantee timely completion, adherence to budgetary constraints, and compliance with Standard Operating Procedures (SOPs), FDA regulations, and ICH/GCP guidelines.
- Identify, engage, and manage the contributions of clinical CROs and other study providers, such as core laboratories and Electronic Data Capture (EDC) services, to facilitate clinical trial execution.
- Review and assist in the creation of study-specific documentation, including clinical trial protocols, case report forms, study manuals, informed consent documents, and clinical databases.
- Evaluate monitoring reports and other necessary study documentation.
- Supervise the collection and organization of clinical trial documentation for inclusion in the Trial Master File (TMF).
- Participate in team meetings and collaborate with various functional groups within the organization (e.g., Clinical Development, Pharmacokinetics, Quantitative Sciences, Regulatory Affairs, Quality Assurance, Finance, Legal) to meet clinical study objectives.
- Track assigned team action items and proactively identify, escalate, and resolve issues as necessary.
- Work alongside contract specialists to review and negotiate clinical trial agreements and site-specific budgets.
- Assess the suitability and feasibility of potential clinical investigators and sites, including evaluating facilities, personnel, patient referral capabilities, and compliance with GCP.
- Develop clinical study monitoring priorities and Monitoring Plans in collaboration with CROs.
- Conduct site visits as required, including training, initiation, and monitoring visits.
- Manage investigational product accountability and the reconciliation process.
- Assist in the preparation of safety, interim, and final clinical study reports, addressing any data discrepancies.
- Provide clinical trial support, mentorship, leadership, and guidance to Clinical Research Associates (CRAs) involved in clinical studies.
- Monitor and track study participant enrollment projections against actual figures and manage study budgets.
- Act as the primary clinical operations liaison for internal and external teams involved in assigned studies.
Qualifications:
- Bachelor's or Master's degree with a minimum of 5+ years of clinical operations experience in the pharmaceutical or biotechnology sector, ideally with a focus on Oncology drug development.
- Hands-on experience managing early-stage clinical trials in an industry context.
- Strong understanding of FDA Regulations, ICH Guidelines, and GCPs governing clinical trial conduct.
- Experience in selecting and managing CROs and external resources.
- Proven track record of effective vendor management and teamwork.
- Direct experience in overseeing clinical CROs.
- Ability to thrive in a collaborative team environment, driven by a desire to implement innovative approaches and technologies.
- Exceptional written and verbal communication skills.
- Demonstrated capability to manage multiple tasks, prioritize effectively, anticipate challenges, and achieve goals as part of an interdisciplinary team.
- Willingness to travel (~25%).
- Oncology experience is preferred.
- Experience with cooperative group studies and investigator-sponsored trials is advantageous.
- Global clinical trial operations experience is a plus.
- Knowledge of APAC regulations is highly desirable.
Preferred Skills and Experience:
Clinical trial management, Phase I-III studies, drug development, Oncology, GCP, FDA, ICH, vendor management, travel, APAC regulations.
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