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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 presents a remarkable opportunity for a seasoned Clinical Operations Professional with a robust background in overseeing Phase I-III clinical trials within the pharmaceutical sector. The ideal candidate will possess extensive knowledge 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, your primary responsibilities will include managing Contract Research Organizations (CROs) and ensuring the successful execution of clinical studies.
Key Responsibilities:
- Oversee clinical operations tasks associated with the execution of designated 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 clinical CROs and other study providers (e.g., core laboratories, Electronic Data Capture (EDC) vendors, and independent contractors) 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.
- Examine monitoring reports and other relevant study documentation as necessary.
- 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 achieve clinical study objectives.
- Follow up on assigned team action items and proactively identify, escalate, and resolve issues as they arise.
- Work alongside contract specialists to review and negotiate clinical trial agreements and site-specific budgets.
- Evaluate the adequacy and feasibility of potential clinical investigators and sites, assessing facilities, personnel, patient referral bases, and compliance with GCP.
- Develop clinical study monitoring priorities and Monitoring Plans in collaboration with CROs.
- Conduct site visits (e.g., training, initiation, monitoring) as required.
- Manage accountability for investigational products and oversee the reconciliation process.
- Assist in preparing safety, interim, and final clinical study reports while addressing data discrepancies.
- Provide clinical trial support, mentorship, leadership, and guidance to Clinical Research Associates (CRAs) assigned to clinical studies.
- Track study participant enrollment projections against actuals and manage study budgets.
- Act as the primary clinical operations contact 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 industry, 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 overseeing clinical CROs.
- Ability to thrive in a collaborative team environment, driven by a commitment to innovative approaches and technologies.
- Exceptional written and verbal communication skills.
- Demonstrated capacity to multitask, 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.
- Experience in global clinical trial operations is a plus.
- Knowledge of APAC regulations is highly desirable.
Desired Skills:
Clinical trial management, Phase I-III studies, drug development, Oncology, GCP, FDA compliance, ICH guidelines, vendor oversight, travel, APAC regulations.
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