Clinical Trials Manager

Job Description
Manages clinical trial studies for specific therapeutic area(s). Provides guidance and oversight to internal and external project team members for the successful management of all aspects of study operation management in accordance with GCP/ICH Guidelines, applicable regulatory requirements, company SOPs, and study protocols.
Primary Responsibilities: ? Oversees third party vendors as well as develops and coordinates responses to third party vendor audits.
? Evaluates vendor performance to ensure early mitigation/resolution of potential issues and develops/implements corrective action plans as appropriate.
? Provides clinical input and/or develops required clinical documents for submission to regulatory authorities (e.g., protocols, investigator brochures, clinical study reports), as necessary.
? Manages overall planning of investigator meetings.
? Develops study specific timelines and manages/mitigates with program timelines.
? Ensures internal functional areas drive to completion of deliverables to manage study issues and support milestone achievement.
? Oversees that study information is effectively communicated to data management, safety, regulatory personnel, and other functional or departmental groups.
? Contributes to study specific clinical risks and opportunities registry for studies assigned including identification of risks, opportunities, contingency and mitigation plans.
? Partners with Biometry to develop robust case report forms, data management plan, data transfer plans, data cleaning, data reconciliation and coordinate clinical review of listings.
? Partners with Manager of Supplies to ensure timely manufacturing, packaging, labeling, and shipping of supplies are created according to regulatory/country specifications in required timeline.
? Works closely with Manager of Contracts in developing and contributing to the study budget, RFPs and Investigator budget template, including participation in and driving the vendor selection process.
? Manages and leads meetings with CROs, vendors, and multi-functional teams on a day-to-day basis to ensure quality, on budget and timeliness of deliverables.
? Reviews site and vendor invoices to ensure that project expenses are in accordance with work conducted.
? Ensures appropriate training is conducted for internal staff, CRO staff, vendors, investigators, and study coordinators on study requirements, therapeutic indication and SOPs.
? Maintains overall responsibility for ensuring the resolution of escalated study conduct issues from study centers, regulatory authorities and IRBs/ECs.
? Reviews escalated issues from study managers and CRAs to ensure adequate mitigation plans are implemented (e.g., investigational site monitoring and site audit report findings).
? Drafts, reviews and approves relevant documents including informed consent, site worksheets, vendor site manuals, pharmacy manual, and central laboratory manual, as necessary.
? Oversees CTMS tracking that supports evaluation and continual management of clinical study set-up and follow-up study activities.
? Monitors adherence to the regulatory/essential document collection process and release of clinical supplies.
? Manages the trial master file process including ongoing maintenance, accurate filing and administration of QC plan.
? Reviews tables, listings, and EDC data to ensure integrity of data and identify trends.
Key Competencies Required: 1. Leadership and People Management:
Training and Development: Skill in ensuring appropriate training for internal staff, CRO staff, vendors, investigators, and study coordinators.
2. Vendor Management:
Oversight and Evaluation: Experience in overseeing third-party vendors, evaluating their performance, and managing responses to vendor audits.
Issue Resolution: Capability to develop and implement corrective action plans for vendor-related issues.
3. Regulatory and Clinical Documentation:
Document Development: Proficiency in developing and providing clinical input for regulatory documents such as protocols, investigator brochures, and clinical study reports.
Regulatory Compliance: Understanding of regulatory requirements and ensuring compliance through accurate documentation and timely submissions
4. Project and Study Management:
Timeline Management: Expertise in developing and managing study-specific timelines, coordinating with program timelines, and ensuring milestone achievement.
Study Coordination: Ability to oversee the planning and execution of investigator meetings and manage study information flow across various functional areas.
5. Risk and Opportunity Management:
Risk Identification and Mitigation: Skill in contributing to the study-specific clinical risks and opportunities registry, identifying risks and opportunities, and developing contingency and mitigation plans.
6. Collaboration and Coordination:
Cross-Functional Partnerships: Ability to work effectively with various stakeholders including Biometry, Manager of Supplies, Manager of Contracts, and other functional groups.
Meeting Management: Experience in managing and leading meetings with CROs, vendors, and multi-functional teams to ensure quality and timely deliverables.
7. Financial and Contract Management:
Budget Development: Competency in developing and contributing to study budgets, RFPs, and Investigator budget templates
Invoice Review: Skill in reviewing site and vendor invoices to ensure alignment with project expenses.
8. Quality Assurance and Issue Resolution:
Issue Resolution: Capability to handle escalated issues from study centers, regulatory authorities, and IRBs/ECs, ensuring adequate mitigation plans are in place.
Data Integrity: Ability to review tables, listings, and EDC data to ensure data integrity and identify trends.
9. Documentation and Record Management:
Trial Master File Management: Experience in managing the trial master file process, including maintenance, accurate filing, and adherence to the QC plan.
Manuals and Documents Review: Proficiency in drafting, reviewing, and approving relevant study documents such as informed consent forms, site worksheets, and study manuals.
10. Technical Skills:
CTMS Tracking: Familiarity with CTMS tracking systems to support the evaluation and management of study set-up and follow-up activities.
Data Management: Ability to partner with data management teams to develop robust data management plans and ensure effective data cleaning and reconciliation.