Note: The job is a remote job and is open to candidates in USA. Bayside Solutions is seeking an experienced Contract Clinical Trial Manager to support clinical studies for a fast-paced biotechnology organization. The role leads and oversees clinical trial activities from startup through closeout, including cross-functional coordination, vendor management, regulatory compliance, study documentation, budgets, monitoring, and patient safety.
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
Skills
- • 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
- Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate
Benefits
- Remote Role - PST
- W2 Contract
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