Clinical Trial Manager

Bayside Solutions; California (MO); On-site; USD 95,000 - 130,000; Full time

Job summary

Bayside Solutions, a biotechnology-focused firm, seeks an experienced Contract Clinical Trial Manager to lead trials from startup through closeout. You will coordinate with Regulatory Affairs, Clinical Pharmacology, QA, Legal, Data Management and Biostatistics to ensure study progression and compliance.

Responsibilities include vendor management (Central Lab, IRT, CRO), TMF oversight, protocol development support, and budget tracking.

Qualifications

• Bachelor's degree with 5-8 years, or master's degree with 5 years, of Clinical Operations experience in the pharmaceutical/biotechnology industry
• Thorough knowledge of ICH/GCP guidelines
• Experience in the Clinical Study Lead role from startup through closedown and cross-functional leadership
• Experience successfully managing vendors independently, including Central Lab, IRT, and CRO vendors"],
• job_responsibilities_description":[

Responsibilities

• Supporting the conduct, management, and completion of assigned clinical trials under the leadership and guidance of the Clinical Study Lead.
• Partnering with team members and other functional areas to perform study-related activities.
• Providing accurate and up-to-date information, including study status reports, to the study team members.
• Timely issue escalation to the Clinical Study Lead and assisting with the resolution of issues.
• Ensuring significant issues that affect the timeline, budget, or resourcing are escalated appropriately.
• Supporting development of key study documents (Protocol, ICFs, CSRs, etc.).
• Reviewing/approving study work orders, change orders, and invoices.
• Managing the study vendor selection process, including RFIs, budget negotiation, and change orders.
• Oversight of study systems (Central Lab, IRT) and TMF throughout the study.
• Maintaining contact with CRO and study vendors and QA audits.
• Preparing details for initial public trial registration and ensuring changes are reviewed, approved, and submitted.

Skills

Clinical Trial Management

Clinical Operations

Vendor Management

TMF oversight

ICH-GCP Compliance

Cross-Functional Leadership

Project Management

Risk Management

Study Start-Up and Closeout

CRO Oversight

Site Budget Negotiation

Contract and Invoice Review

Study Budgets

Regulatory Compliance

Inspection Readiness

Clinical Study Documentation

Patient Safety

IP Forecasting

Quality Assurance

Education

Bachelor's degree in a related field

Master's degree in a related field

Tools

Microsoft Word

Microsoft Project

PowerPoint

Excel

SharePoint

Job description

We are seeking an experienced and highly motivated Contract Clinical Trial Manager to apply expertise in leading innovative clinical study trials from startup through closedown at our fast-paced small biotechnology organization.

Duties and Responsibilities:

• Supporting the conduct, management, and completion of assigned clinical trials under the leadership and guidance of the Clinical Study Lead.
• Partnering with team members and other functional areas, including Regulatory Affairs, Clinical Pharmacology, Clinical Development, Quality Assurance, Legal, Data Management, and Biostatistics, to perform study-related activities.
• Providing accurate and up-to-date information, including study status reports, to the study team members.
• Timely issue escalation to the Clinical Study Lead and assisting with the resolution of issues.
• Ensuring significant issues that affect the timeline, budget, or resourcing are escalated appropriately.
• Supporting development of key study documents, including Protocol, ICFs, CSRs, and study-specific plans (Pharmacy Manual, Vendor Oversight Plan, Vendor-Specific Plans, etc.).
• Reviewing/approving study work orders, change orders, and invoices.
• Managing the study vendor selection process, including requests for proposals, budget negotiation, work order setup, and change orders.
• Responsibility and accountability for oversight of study vendors, including overseeing or directing the setup, maintenance, and closedown of study systems such as Central Lab and IRT.
• Maintaining frequent contact with and working effectively with CRO and study vendors.
• Overseeing the TMF throughout the conduct of the study and participating in periodic QC.
• Confirming documents to be included in TMF, timelines, recipients, and the process for distribution.
• Approving site budget templates, negotiating site budgets, along with site payments, and any necessary changes.
• Ensuring oversight of monitoring activities (i.e., review of monitoring visit reports, protocol deviations) to protect subject safety and ensure compliance with regulatory requirements.
• Leading review of protocol deviations and follow-up, in collaboration with CRO and study team.
• Assessing the impact of amendments and leading associated changes to study timelines, budget, vendor responsibilities, and study-specific systems.
• Assisting with review of CRF design; ensuring queries are resolved, generation of any interim data cuts, and preparation of any DRT/DRC charters, if applicable.
• Collaborating with Clinical Development to ensure patient safety.
• Collaborating with Clinical Supplies to forecast and maintain adequate IP supplies and set up IRT.
• Collaborating with Regulatory Affairs to ensure regulatory compliance for study conduct.
• Collaborating with Quality Assurance (QA) to ensure quality events are properly addressed, that investigative sites and vendors are properly qualified, to provide assistance with inspection readiness activities, to ensure QA vendor selection audits are complete, and to ensure that investigative sites' audits are performed, as necessary.
• Preparing details for initial public trial registration and ensuring changes are reviewed, approved, and submitted.

Requirements and Qualifications:

• Bachelor's degree with 5-8 years, or master's degree with 5 years, of Clinical Operations experience in the pharmaceutical/biotechnology industry
• Thorough knowledge of ICH/GCP guidelines
• Experience in the Clinical Study Lead role from startup through closedown, and able to lead a cross-functional team and direct the work of others in a matrix environment.
• Demonstrated successful collaboration with other functional area representatives
• Experience successfully managing vendors independently, including Central Lab, IRT, and CRO vendors.
• Strong communication skills to ensure that clinical study plans are transparent, and risks, issues, and results are clear to all SMT stakeholders
• Ability to interpret study-level data (both operational and clinical) and identify risks and mitigations
• Demonstrated leadership and interpersonal skills that have enabled you to successfully hire, develop, and retain employees. This includes aligning employees around a common vision and goals, and utilizing complementary strengths and experience to create high-performing teams.
• A collaborative and flexible leadership style that allows you to adapt to the nuances of managing a diverse team and the ongoing training, coaching, and performance management that results in increased engagement and retention
• Excellent written and verbal communication skills
• Adaptability in a dynamic, rapidly evolving organization
• Ability to work collaboratively across geographies
• Proficiency in Microsoft Word, Project, PowerPoint, Excel, and SharePoint

Desired Skills and Experience

Clinical Trial Management, Clinical Operations, Study Start-Up and Closeout, ICH-GCP Compliance, CRO Oversight, Vendor Management, Central Laboratory Management, Interactive Response Technology (IRT), Trial Master File (TMF), TMF Quality Control, Clinical Monitoring Oversight, Protocol Deviations, Risk Management, Issue Escalation, Study Budgets, Contract and Invoice Review, Site Budget Negotiation, Clinical Study Documentation, Protocols, Informed Consent Forms, Clinical Study Reports, Case Report Form Design, Clinical Data Review, Investigational Product Forecasting, Patient Safety, Regulatory Compliance, Inspection Readiness, Clinical Trial Registration, Cross-Functional Leadership, Matrix Team Management, Project Management, Microsoft Word, Microsoft Project, PowerPoint, Excel, SharePoint

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at www.baysidesolutions.com.