Tech Stack

Description

You will manage day-to-day operations of phase 1-3 clinical trials, including start-up, conduct, and close-out activities. This role involves overseeing CROs and service providers, leading cross-functional teams, and ensuring compliance with GCP and regulatory requirements.

Requirements

• B.A./B.S. degree.
• 6+ years of clinical research experience in Biotech or similar industry.
• At least 2 years directly supporting clinical trial management.
• Knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trial management.
• Strong clinical study management skills.
• Understanding of regulatory framework applicable to interactions with HCPs, payers, advocacy.
• Proven clinical operational skills to direct protocol execution.
• Excellent communication skills.
• Experience reviewing trial plans and developing strategies for site monitoring, risk mitigation, budgets, etc.
• Clinical research knowledge and cross-functional understanding of clinical trial methodology.
• Excellent organizational, conflict resolution, prioritization and negotiation skills.
• Proven ability in creative problem-solving and exercising sound judgment.
• Team oriented and ability to collaborate effectively.
• Ability to handle high volume of complex tasks within timeline.
• Ability to develop Therapeutic Areas knowledge and expertise.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
• Working knowledge of MS Project.

Responsibilities

• Serve as primary contact for managing protocol execution, including oversight of CRO and other service providers.
• Lead cross-functional study execution team to support study deliverables.
• Support establishment of study milestones and ensure accurate tracking and reporting.
• Ensure trials are managed in accordance with ICH GCP, regulations, protocol, and SOPs.
• Assist in preparation and review of clinical trial documentation (protocol, ICF, IB, etc.).
• Maintain Trial Master File (TMF) and conduct periodic reviews.
• Participate in service provider selection and outsourcing activities.
• Proactively identify and resolve project issues with support from senior staff.
• Assess operational feasibility, recommend study execution plan and site selection.
• Select and train CRO study staff, monitors, and investigational sites.
• Facilitate development of clinical trial agreements and other documents.
• Manage clinical trial budgets, provide financial reporting and projections.
• Negotiate and finalize site contracts and budgets.
• Perform data review process on an ongoing basis.
• Conduct site visits (qualification, initiation, monitoring, close-out) as needed.
• Oversee outsourced monitoring by reviewing reports and ensuring quality.
• Track and review protocol deviations and assess impact on study data.
• Develop and manage study budget; review and approve clinical invoices.
• Provide oversight for forecasting of clinical supplies.