Clinical Trials Manager (12-month contract)

What You'll Do

• Acts as clinical trial lead on one or two early-phase clinical studies
• Maintains global study timelines and aligns study start-up, enrollment, study conduct and close out activities with corporate goals
• Identifies and ensures compliance with Key Performance Indicator (KPI); Key Risk indicators (KRI); and Key quality indicators (KQI) for assigned clinical trial
• Ensures study is carried out according to the study protocol, SOPs, CFR, ICH/GCP guidelines and study-specific manuals and procedures; collaborates with QA to ensure inspection readiness
• Develops and implements study specific processes and trains study teams
• Works closely with the study management team to develop clinical trial protocols and designs all associated clinical forms, including Case Report Forms, SAE Forms, etc. for assigned clinical trial
• Prepares, reviews, and approves study-related documents (e.g., Monitoring plans, Laboratory Manual, Patient Diary and CRF completion guidelines)
• Proactively identifies study issues/risks and recommends/implements solutions for assigned clinical trial
• Reviews and analyzes clinical trial data routinely to identify, develop and implement changes required for improvement and compliance at site level and/or study level
• Develops and reviews site budgets working closely with finance and CRO partner
• Plans and conducts, investigator meetings, internal team meetings, and other trial-specific meetings
• Affords in-house and on-site quality audits, as well as regulatory authority inspections
• Collaborates with CRO to manage site related interactions and serves as a liaison and resource for investigational sites. Troubleshoots and helps to address recruitment obstacles
• Reviews CRO/vendor invoices for accuracy
• Reviews and analyzes the initial and revised scope of service agreements, budgets, plans, and detailed timelines ensuring that performance expectations (timeline/quality/cost) are met with the CRO/vendor
• Manages assigned clinical trial with minimal oversight
• Participates in the selection, training, and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function
• Develops and implements processes with efficiencies for assigned clinical study
• Fosters effective and collaborative working relationships with fellow employees, management, and external partners

What You'll Bring

• University degree and relevant clinical trials experience in pharmaceutical, biotech or CRO setting including clinical trial management experience
• Minimum of 5 years’ pharmaceutical industry drug safety experience, optimally in a small-to-mid cap biotech environment
• An equivalent combination of education and experience may be considered
• Prior experience in lead role of global clinical trials is required
• CRO/vendor management and oversight experience are required
• Oncology clinical research experience is preferred
• Knowledge of and experience with international regulatory adverse event reporting requirements
• Demonstrated line management experience
• Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team
• Excellent communication and organizational skills and the ability to work effectively in a high paced, fast changing environment
• Thorough knowledge of FDA/EMA, CFR and GCP/ICH requirements
• Ability to work independently, establish functional priorities and execute on goals
• Experience in oncology drug development desirable
• Ability to travel for site co-monitoring activities, vendor visits/audits as required (up to 30%)