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Senior Clinical Operations Manager
2 months ago
Position: Clinical Trial Manager / Senior Clinical Trial Manager
Contract Type: W2 Contract-to-Hire
Compensation: $156,000 - $187,200 annually
Work Arrangement: Hybrid or Remote
Overview:
This position offers a remarkable opportunity for a seasoned Clinical Operations Professional with specialized knowledge in overseeing Phase I-III clinical trials within the pharmaceutical sector. The ideal candidate will possess a robust 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 take charge of the oversight of Contract Research Organizations (CROs) and the implementation of clinical studies.
Key Responsibilities:
- Execute clinical operations tasks pertinent to the management of assigned clinical trials in alignment with departmental and corporate objectives.
- Oversee clinical studies and associated vendors to guarantee timely completion, adherence to budgetary constraints, and compliance with Standard Operating Procedures (SOPs), FDA regulations, and ICH/GCP guidelines.
- Identify, engage, and supervise the activities of clinical CROs and other study providers (e.g., core laboratories, Electronic Data Capture (EDC) providers, and independent contractors) for effective trial execution.
- Contribute to the development of study-specific documentation, including clinical trial protocols, case report forms, study manuals, informed consent documents, and clinical databases.
- Review monitoring reports and other necessary study documentation.
- Ensure the collection and management of clinical trial documentation for filing 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.
- Follow up on assigned team action items, identifying, escalating, and resolving issues as required.
- Work with 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 capabilities, 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 necessary.
- 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, preferably with a focus on Oncology drug development.
- Hands-on experience managing early-stage clinical trials in an industry context.
- Strong knowledge 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 managing clinical CROs.
- Ability to thrive in a collaborative team environment, driven by a desire to implement innovative approaches and technologies.
- Excellent written and verbal communication skills.
- Demonstrated capacity to multi-task, prioritize tasks, 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 a plus.
- Global clinical trial operations experience is advantageous.
- Knowledge of APAC regulations is highly desirable.
Desired Skills:
Clinical trial management, Phase I-III studies, drug development, Oncology, GCP, FDA, ICH, vendor oversight, travel, APAC regulations.
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